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1.
Gynecol Oncol ; 161(3): 681-686, 2021 06.
Article En | MEDLINE | ID: mdl-33795131

OBJECTIVE: Despite radical surgery and chemotherapy, most patients with ovarian cancer die due to disease progression. M-Trap is an implantable medical device designed to capture peritoneal disseminated tumor cells with the aim to focalize the disease. This trial analyzed the safety and performance of the device. METHODS: This first-in-human prospective, multi-center, non-blinded, single-arm study enrolled 23 women with high-grade serous advanced ovarian cancer. After primary or interval debulking surgery, 3 M-Trap devices were placed in the peritoneum of the abdominal cavity. 18-months post-implantation or at disease progression, devices were initially removed by laparoscopy. The primary safety endpoint was freedom from device and procedure-related major adverse events (MAEs) through 6-months post-implantation compared to an historical control. The primary performance endpoint was histopathologic evidence of tumor cells capture. RESULTS: Only one major adverse event was attributable to the device. 18 women were free of device and procedure related MAEs (78.3%). However, the primary safety endpoint was not achieved (p = 0.131), primarily attributable to the greater surgical complexity of the M-Trap patient population. 62% of recurrent patients demonstrated tumor cell capture in at least one device with a minimal tumor cell infiltration. No other long-term device-related adverse events were reported. The secondary performance endpoint demonstrated a lack of disease focalization. CONCLUSIONS: The M-Trap technology failed to meet its primary safety objective, although when adjusted for surgical complexity, the study approved it. Likewise, the devices did not demonstrate the anticipated benefits in terms of tumor cell capture and disease focalization in recurrent ovarian cancer.


Carcinoma, Ovarian Epithelial/surgery , Cytoreduction Surgical Procedures/instrumentation , Neoplasm Recurrence, Local/surgery , Ovarian Neoplasms/surgery , Peritoneal Neoplasms/surgery , Adult , Aged , Carcinoma, Ovarian Epithelial/secondary , Female , Humans , Middle Aged , Neoplasm Metastasis , Neoplasm Recurrence, Local/pathology , Ovarian Neoplasms/pathology , Peritoneal Neoplasms/secondary , Prospective Studies , Spain , Treatment Outcome
2.
Br J Cancer ; 123(10): 1471-1473, 2020 11.
Article En | MEDLINE | ID: mdl-32830203

Ovarian cancer surgery endeavours to remove all visible tumour deposits, and surgical technologies could potentially facilitate this aim. However, there appear to be barriers around the adoption of new technologies, and we hope this article provokes discussion within the specialty to encourage a forward-thinking approach to new-age surgical gynaecological oncology.


Carcinoma, Ovarian Epithelial/surgery , Gynecologic Surgical Procedures/methods , Medical Oncology/methods , Ovarian Neoplasms/surgery , Practice Patterns, Physicians'/trends , Carcinoma, Ovarian Epithelial/epidemiology , Combined Modality Therapy/history , Combined Modality Therapy/methods , Combined Modality Therapy/trends , Cytoreduction Surgical Procedures/instrumentation , Cytoreduction Surgical Procedures/methods , Cytoreduction Surgical Procedures/trends , Female , Fertility Preservation/methods , Fertility Preservation/trends , Gynecologic Surgical Procedures/adverse effects , Gynecologic Surgical Procedures/history , Gynecologic Surgical Procedures/trends , History, 20th Century , History, 21st Century , Humans , Inventions/trends , Medical Oncology/history , Medical Oncology/trends , Morbidity , Ovarian Neoplasms/epidemiology , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Postoperative Complications/prevention & control , Practice Patterns, Physicians'/history , Robotic Surgical Procedures/history , Robotic Surgical Procedures/instrumentation , Robotic Surgical Procedures/methods , Robotic Surgical Procedures/trends , Therapies, Investigational/instrumentation , Therapies, Investigational/methods , Therapies, Investigational/psychology , Therapies, Investigational/trends
3.
Brasília; CONITEC; mar. 2020.
Non-conventional Pt | BRISA | ID: biblio-1122930

INTRODUÇÃO: A associação de cirurgia citorredutora e perfusão intraoperatória da cavidade peritoneal, com solução quimioterápica hipertérmica, representa uma nova e promissora modalidade terapêutica para o MPM. Sua incidência varia em todo o mundo, sendo as maiores taxas observadas na Austrália, Bélgica e Grã-Bretanha. O surgimento do MPM está associado à exposição ao amianto. Com longo período de latência (15 a 60 anos), é esperado aumento na incidência do MPM nas próximas décadas. Em países como o Brasil, também é esperado aumento na mortalidade por essa neoplasia nos próximos anos. PERGUNTA: O tratamento com cirurgia de citorredução com hipertermoquimioterapia é mais eficaz e custo-efetivo em pacientes com mesotelioma peritoneal difuso maligno quando comparado à quimioterapia sistêmica? TECNOLOGIA: Cirurgia de Citorredução (peritonectomia) com Quimioterapia Intraperitoneal Hipertérmica (HIPEC). EVIDÊNCIAS CIENTÍFICAS: Não foram encontrados ensaios clínicos sobre cirurgia de citorredução + HIPEC específicos para pacientes com MPM. Como a intervenção em questão é a HIPEC, estudos que utilizaram quimioterapia intraperitoneal normotérmica não foram considerados. Foram selecionados 11 estudos observacionais, que utilizaram bancos de dados de pacientes atendidos, em um ou mais centros de saúde. O número de pacientes avaliados nesses estudos variou de 11 a 401, e o período de coleta de dados de 3 a 26 anos. As técnicas de HIPEC utilizadas foram: em 4 estudos abdômen aberto (ou técnica do Coliseu); em outros 4 estudos abdômen fechado; em 2 estudos multicêntricos as abordagens cirúrgicas (aberta ou fechada) variaram entre os centros participantes e em um dos estudos detalhes da técnica não foram informados. A temperatura da HIPEC variou entre 40C e 43C, o tempo de administração da quimioterapia variou de 60 a 120 minutos, e a mitomicina c, associada ou não a outro medicamento (platina), foi utilizada na maioria dos estudos. A maioria dos estudos apresenta dados de sobrevida global em 5 anos, sendo observada uma variação entre 27% e 80,8%. AVALIAÇÃO ECONÔMICA: Foram simulados 24 pacientes em cadeia de Markov, com horizonte temporal da vida toda, sob a perspectiva do SUS utilizando uma taxa de desconto de 5%. A razão de custo efetividade incremental (ICER) do procedimento foi estimada em R$56.929,28/ano de vida ganho. Em nenhuma das simulações o valor foi estimado abaixo de 1 PIB per capita. Quando o valor da cirurgia é reduzido a R$34.621,00 o ICER é igual a esse limiar. AVALIAÇÃO DE IMPACTO ORÇAMENTÁRIO: A avaliação de impacto orçamentário estimou o valor incremental por centro de saúde assumindo que este realizaria 24 procedimentos por ano. Foi construído um modelo dinâmico de microssimulação com horizonte temporal de 5 anos. O parecer da SBCO estimou em 120-200 casos por ano de pseudomixoma peritoneal e mesotelioma peritoneal somados elegíveis para o procedimento. O resultado do impacto orçamentário médio anual para os 24 pacientes é R$ 1.692.864,36. Para toda a população, os valores por ano variaram de R$ 8.661.117,15 a R$ 14.657.044,06. RECOMENDAÇÃO PRELIMINAR: O Plenário da CONITEC realizado em 04 de dezembro de 2019, considerou que, apesar da evidência científica ser restrita, os resultados apontam para uma maior eficácia do tratamento com cirurgia de citorredução + HIPEC para os pacientes com mesotelioma peritoneal. A avaliação econômica encontrou uma razão de custoefetividade incremental com valor próximo a 2 PIB per capita por ano de vida ganho, o que foi considerado aceitável por se tratar de uma condição clínica rara. Portanto, emitiu-se recomendação preliminar pela incorporação no SUS da cirurgia de citorredução (peritonectomia) com Quimioterapia Intraperitoneal Hipertérmica (HIPEC), para tratamento de mesotelioma peritoneal. Essa incorporação deverá ser feita em centros de saúde com profissionais capacitados para realização, por se tratar de um procedimento complexo. CONSULTA PÚBLICA: Foram recebidas 45 contribuições técnico-científicas e 13 contribuições de experiência ou opinião, a grande maioria concordante com a recomendação preliminar da CONITEC a favor da incorporação da cirurgia de citorredução + HIPEC para o tratamento de mesotelioma peritoneal. Apenas uma contribuição não concorda, nem discorda da recomendação, mas relata não ter experiência com o tema. Não há argumentação que justifique a alteração da recomendação inicial. RECOMENDAÇÃO FINAL: Os membros da Conitec presentes na 86° reunião ordinária, nos dias 4 e 5 de março de 2020, deliberaram, por unanimidade, por recomendar a incorporação da cirurgia de citorredução + HIPEC para o tratamento de mesotelioma peritoneal, no SUS, conforme protocolo a ser elaborado pelo Ministério da Saúde. DECISÃO: incorporar a cirurgia de citorredução com hipertermoquimioterapia em pacientes com mesotelioma peritoneal maligno, conforme estabelecido pelo Ministério da Saúde, no âmbito do Sistema Único de Saúde - SUS, conforme a Portaria nº 12, publicada no Diário Oficial da União nº 64, seção 1, página 91, em 2 de abril de 2020.


Humans , Peritoneum/pathology , Chemotherapy, Adjuvant/instrumentation , Cytoreduction Surgical Procedures/instrumentation , Mesothelioma/surgery , Technology Assessment, Biomedical , Unified Health System , Brazil , Cost-Benefit Analysis/economics
4.
Brasília; CONITEC; mar. 2020.
Non-conventional Pt | BRISA | ID: biblio-1129256

INTRODUÇÃO: O pseudomixoma peritoneal (PMP) é uma condição clínica caracterizada por ascite mucinosa geralmente decorrente de uma neoplasia epitelial perfurada de apêndice. A abordagem de tratamento mais indicada atualmente consiste em uma modalidade cirúrgica e quimioterapêutica e parece ganhar terreno como tratamento padrão para doenças superficiais peritoneais de todos os tipos de origem. Nesse tratamento, procedimentos de peritonectomia com ressecção das vísceras envolvidas, visa ressecção de superfícies peritoneais, facilitando assim a realização de uma citorredução macroscópica completa. Além disso, com o objetivo de erradicar qualquer resíduo de tumor macroscópico ou microscópico para evitar a recorrência, a cirurgia é combinada com quimioterapia intraperitoneal hipertérmica (HIPEC). Esse tratamento de modalidade combinada é uma abordagem com intenção curativa, principalmente em pacientes com PMP, devido ao padrão característico de disseminação e ao caráter não invasivo. PERGUNTA: O tratamento com cirurgia de citorredução com hipertermoquimioterapia é mais eficaz e custo-efetivo para a sobrevida de pacientes com pseudomixoma peritoneal quando comparado à quimioterapia sistêmica? TECNOLOGIA: Cirurgia de Citorredução (peritonectomia) com Quimioterapia Intraperitoneal Hipertérmica (HIPEC). EVIDÊNCIAS CIENTÍFICAS: Não foram encontrados ensaios clínicos sobre cirurgia de citorredução + HIPEC específicos para pacientes com pseudomixoma peritoneal. Os 15 estudos selecionados são observacionais, com número de pacientes entre 29 e 636 e com período de coleta de dados variando entre 3 e 26 anos. A sobrevida global em 5 anos variou entre 42% e 94%. Os estudos com maior número de indivíduos analisados apresentaram sobrevida global em 5 anos de 73% e 84%. Para os dois estudos publicados mais recentemente, os valores de sobrevida em 5 anos foram de 87% e 82%. Mesmo não tendo sido encontrados estudos com grupo de comparação, os estudos observacionais que utilizaram métodos de tratamento mais antigos (cirurgia e/ou quimioterapia sistêmica) encontraram valores de sobrevida global inferiores, sugerindo de forma indireta uma superioridade do método de citorredução +HIPEC. AVALIAÇÃO ECONÔMICA: Foram simulados 24 pacientes em cadeia de Markov, com horizonte temporal de 7 anos, sob a perspectiva do SUS e utilizando uma taxa de desconto de 5%. A razão de custo efetividade incremental (ICER) do procedimento foi estimada em R$68.920,00/QALY. Em nenhuma das simulações o valor foi estimado abaixo de 1 PIB per capita. Quando o valor da cirurgia é reduzido a R$21.393,00 o ICER é igual a esse limiar. AVALIAÇÃO DE IMPACTO ORÇAMENTÁRIO: A avaliação de impacto orçamentário estimou o valor incremental por centro de saúde assumindo que este realizaria 24 procedimentos por ano. Foi construído um modelo dinâmico de microssimulação com horizonte temporal de 5 anos. O parecer da SBCO estimou em 120-200 casos por ano no Brasil de pseudomixoma peritoneal e mesotelioma peritoneal somados elegíveis para o procedimento. O resultado do impacto orçamentário médio anual para os 24 pacientes é R$ 1.692.864,36. Para toda a população, os valores por ano variaram de R$ 8.661.117,15 a R$ 14.657.044,06. RECOMENDAÇÃO PRELIMINAR: O Plenário da CONITEC realizado em 04 de dezembro de 2019, considerou que, apesar da evidência científica ser restrita, os resultados apontam para uma maior eficácia do tratamento com cirurgia de citorredução + HIPEC para os pacientes com PMP. A avaliação econômica encontrou uma razão de custo-efetividade incremental com valor próximo a 2 PIB per capita, o que foi considerado aceitável por se tratar de uma condição clínica rara. Portanto, emitiu-se recomendação preliminar pela incorporação no SUS da Cirurgia de citorredução (peritonectomia) com Quimioterapia Intraperitoneal Hipertérmica (HIPEC), para tratamento de PMP. Essa incorporação deverá ser feita em centros de saúde com profissionais capacitados para realização, por se tratar de um procedimento complexo. CONSULTA PÚBLICA: Foram recebidas 58 contribuições técnico-científicas e 8 contribuições de experiência ou opinião, a grande maioria concordante com a recomendação preliminar da CONITEC a favor da incorporação da cirurgia de citorredução + HIPEC para o tratamento de pseudomixoma peritoneal. Apenas uma contribuição foi discordante. Não há argumentação que justifique a alteração da recomendação inicial. RECOMENDAÇÃO FINAL: Os membros da Conitec presentes na 86° reunião ordinária, nos dias 4 e 5 de março de 2020, deliberaram, por unanimidade, por recomendar a incorporação da cirurgia de citorredução + HIPEC para o tratamento de pseudomixoma peritoneal, no SUS, conforme protocolo a ser elaborado pelo Ministério da Saúde. DECISÃO: incorporar a cirurgia de citorredução com hipertermoquimioterapia em pacientes com pseudomixoma peritoneal, conforme estabelecido pelo Ministério da Saúde, no âmbito do Sistema Único de Saúde - SUS, conforme a Portaria nº 13, publicada no Diário Oficial da União nº 64, seção 1, página 91, em 2 de abril de 2020.


Humans , Pseudomyxoma Peritonei/surgery , Cytoreduction Surgical Procedures/instrumentation , Technology Assessment, Biomedical , Unified Health System , Brazil , Cost-Benefit Analysis/economics
5.
London; European Society of Surgical Oncology; Feb. 28, 2020. 25 p.
Non-conventional En | BIGG | ID: biblio-1117236

Pseudomyxoma Peritonei (PMP) is a rare peritoneal malignancy, most commonly originating from a perforated epithelial tumour of the appendix. Given its rarity, randomized controlled trials on treatment strategies are lacking, nor likely to be performed in the foreseeable future. However, many questions regarding the management of appendiceal tumours, especially when accompanied by PMP, remain unanswered. This consensus statement was initiated by members of the Peritoneal Surface Oncology Group International (PSOGI) Executive Committee as part of a global advisory role in the management of uncommon peritoneal malignancies. The manuscript concerns an overview and analysis of the literature on mucinous appendiceal tumours with, or without, PMP. Recommendations are provided based on three Delphi voting rounds with GRADE-based questions amongst a panel of 80 worldwide PMP experts.


Humans , Female , Pseudomyxoma Peritonei/prevention & control , Cytoreduction Surgical Procedures/instrumentation , Hyperthermia, Induced/instrumentation
6.
Surg Endosc ; 34(2): 536-543, 2020 02.
Article En | MEDLINE | ID: mdl-30963261

BACKGROUND: Laparoscopic liver resection (LLR) of posterosuperior (PS) segment liver tumors is technically challenging with confusion about optimal patient positioning and trocar placement (i.e., transabdominal vs. transcostal). The aim of this study is to describe our technique and outcomes with LLR of these tumors. METHODS: This is an IRB-approved retrospective review of a prospective database. Between 2005 and 2017, patients with benign and malignant lesions underwent LLR. Perioperative outcomes of PS (segments 4A, 7, and 8) and anterolateral (AL) resections were compared. All patients were operated through intra-abdominal trocars in the supine position. RESULTS: 304 patients underwent LLR for AL (n = 217) and PS (n = 87) segmental lesions. Minor liver resections were performed in 274 patients and major resections in 30. Groups were comparable for age, sex, pathology, and tumor size (mean 4.2 and 3.7 cm for AL and PS). Inflow occlusion was more frequently performed for PS resections, but precoagulation rates were similar. PS resections more frequently required hand assistance (50% vs. 20%, p < 0.001) and conversion to open (18% vs. 7%, p = 0.04). For PS versus AL resections, operative time (253 vs. 205 min, p ≤ 0.001) was longer and associated with more blood loss (307 vs. 211 mL, p < 0.001) and more frequent need for blood transfusion (15% vs. 7%, p = 0.04). However, the rate of negative resection margin, 90-day complication rates, and length of stay were similar between the two groups. CONCLUSION: This study shows that LLR of PS located liver tumors is more challenging compared to AL lesions. Nevertheless, it can be performed successfully in the majority of patients with supine positioning and intra-abdominal trocar placement, without compromising oncologic principles. Liberal uses of hand assistance and inflow occlusion were the technical tips helping us to successfully resect these tumors laparoscopically.


Hepatectomy/instrumentation , Laparoscopy/instrumentation , Liver Neoplasms/surgery , Minimally Invasive Surgical Procedures/instrumentation , Surgical Instruments , Adult , Aged , Cytoreduction Surgical Procedures/instrumentation , Cytoreduction Surgical Procedures/methods , Female , Hepatectomy/methods , Humans , Laparoscopy/methods , Male , Margins of Excision , Middle Aged , Minimally Invasive Surgical Procedures/methods , Operative Time , Patient Positioning , Retrospective Studies , Supine Position
7.
Can J Urol ; 26(5): 9963-9972, 2019 10.
Article En | MEDLINE | ID: mdl-31629449

For men experiencing lower urinary tract symptoms (LUTS) refractory to medical therapy, there have been numerous developments in the treatment options offered for benign prostatic hyperplasia (BPH) in the recent years. Transurethral resection of the prostate (TURP) has remained the reference standard for men with prostates sized 30 cc-80 cc, while open prostatectomy is universally guidelines-recommended in the absence of enucleation, for men with prostates larger than 80 cc-100 cc. While these techniques are effective, they have the potential for bleeding complications requiring transfusions, electrolyte abnormalities such as TURP syndrome, and often require prolonged hospitalization. GreenLight photoselective vaporization (GL-PVP) with the XPS LBO-180W system offers a minimally invasive treatment that can be carried out on essential any sized prostate gland. In addition, the GL-PVP procedure can be done as a same day discharge surgery requiring no overnight hospital admission and allows patients to continue any necessary anti-coagulants given the significantly reduced risks of bleeding complications or TURP syndrome. In 2005, the anatomic vaporization-incision technique (VIT) using the XPS LBO-180W system was described to address larger prostate volumes. VIT combines principles of traditional GL-PVP and enucleation techniques to identify the reference surgical capsule early-on into the surgery and resect portions of prostate adenoma without the need for tissue morcellation. Early studies comparing anatomic VIT to standard PVP outcomes demonstrated significant improvements of IPSS and uroflowmetry parameters, along with statistically significant greater PSA reduction at 6 months, particularly in prostate volumes greater than 80 cc. The objective of this article is to detail our surgical approach to the anatomic GreenLight laser vaporization-incision technique using the XPS LBO-180W system, based on extensive personal experience with both enucleation and vaporization techniques using various laser technologies. Standardization of the VIT based on proper cystoscopy, knowledge of prostate anatomy with preoperative ultrasound, and routine technique is essential to developing consistent, reproducible and optimal surgical outcomes.


Adenoma/surgery , Cytoreduction Surgical Procedures/methods , Laser Therapy/methods , Prostatic Hyperplasia/surgery , Prostatic Neoplasms/surgery , Color , Cystoscopy , Cytoreduction Surgical Procedures/instrumentation , Humans , Laser Therapy/instrumentation , Male , Patient Selection , Postoperative Care
8.
Gynecol Oncol ; 155(2): 220-223, 2019 11.
Article En | MEDLINE | ID: mdl-31488245

OBJECTIVES: To determine if intraperitoneal (IP) ports placed concurrently with bowel resection during surgical treatment of ovarian cancer is associated with more complications than those ports placed without concurrent bowel resection. METHODS: The medical records of all patients who had an IP port placed at our institution between 2005 and 2016 were reviewed. Two groups were analyzed: IP ports placed with bowel resection (IP-BR) and those without (IP). RESULTS: Of 306 patient charts reviewed, 31% had a surgery with IP port placement and concurrent bowel resection (IP-BR). Demographics were similar except for mean BMI (25.6 IP-BR vs 27.4 IP, p = 0.007). More IP-BR patients had stage IIIC disease (83.3% IP-BR vs 56.9% IP, p ≤0.01). Patients were cytoreduced to R0 in 48.7% IP-BR vs 56.4% IP (p = 0.253). For adjuvant treatment, IV chemotherapy was administered before IP chemotherapy in 90.4% IP-BR (median 2 cycles), and 50.3% IP, (median 2 cycles, p < 0.01). Ultimately 80.2% IP-BR (median 4 cycles) and 77.8% IP (median 5 cycles) received IP chemotherapy (p = 0.65). Rates of total IP port complications were similar (19.2% IP-BR vs 23.2% IP, p = 0.397), including IP port infections (0% IP-BR vs 0.7% IP, p = 0.5). Eleven percent of IP-BR patients had a bowel complication (e.g. obstruction or perforation) while IP port was in situ vs 2.7% IP (p = 0.01). Only 2.7% IP-BR and 6% IP discontinued IP chemotherapy due to IP port complication (p = 0.3). CONCLUSIONS: Patients who have IP ports placed concurrently with a bowel resection do not appear to have more complications, nor lower rates of IP chemotherapy administration.


Laparoscopy/instrumentation , Ovarian Neoplasms/surgery , Antineoplastic Agents/therapeutic use , Chemotherapy, Adjuvant , Cytoreduction Surgical Procedures/adverse effects , Cytoreduction Surgical Procedures/instrumentation , Cytoreduction Surgical Procedures/methods , Female , Humans , Laparoscopy/adverse effects , Laparoscopy/methods , Middle Aged , Neoplasm Recurrence, Local/etiology , Ovarian Neoplasms/drug therapy , Peritoneum/surgery , Postoperative Complications/etiology , Retrospective Studies , Surgical Instruments/adverse effects , Treatment Outcome
9.
In Vivo ; 33(5): 1641-1644, 2019.
Article En | MEDLINE | ID: mdl-31471417

BACKGROUND: An open-label, single-arm study was conducted to assess the safety of a cryosurgery unit named CRYO2 for debulking at the site of obstruction or stenosis. PATIENTS AND METHODS: In order to treat central airway tumor-related stenosis, debulking at the stenotic site of the airway was performed using CRYO2 under general or local anesthesia. The primary endpoint was the incidence of moderate to massive hemorrhage. RESULTS: Incidence of moderate to massive hemorrhage during surgery was 3.8% (1/26) (95% confidence interval(CI)=0.1-19.6%). Technical success was 96.2% (25/26), with a 95% confidence interval of 80.4-99.9%. CONCLUSION: CRYO2 for debulking at the site of obstruction or stenosis can be performed safely.


Airway Obstruction/pathology , Airway Obstruction/surgery , Constriction, Pathologic/surgery , Cytoreduction Surgical Procedures , Adult , Aged , Aged, 80 and over , Airway Obstruction/etiology , Constriction, Pathologic/diagnosis , Constriction, Pathologic/etiology , Cryosurgery/adverse effects , Cryosurgery/instrumentation , Cryosurgery/methods , Cytoreduction Surgical Procedures/adverse effects , Cytoreduction Surgical Procedures/instrumentation , Cytoreduction Surgical Procedures/methods , Female , Humans , Hypoxia/etiology , Hypoxia/therapy , Male , Middle Aged , Oxygen/administration & dosage , Respiratory Tract Neoplasms/complications , Respiratory Tract Neoplasms/diagnosis , Respiratory Tract Neoplasms/therapy , Treatment Outcome
10.
J Ovarian Res ; 12(1): 71, 2019 Jul 31.
Article En | MEDLINE | ID: mdl-31362769

About 80 % of all women affected by ovarian cancer present with advanced stage disease at the time of diagnosis. Achieving complete cytoreduction is complicated when many small tumor spots are found. Yet, complete cytoreduction is the most important determinant of survival.Application of a thermal plasma energy device to standard surgical instruments may help achieve complete cytoreduction. The 'PlasmaJet® Device' (Plasma Surgical, Inc., Roswell, GA, USA) is an electrically neutral device which emits a high-energy jet of argon plasma for direct tissue effects. We performed a literature review to investigate whether the use of the 'PlasmaJet® Device' in surgery of advanced stage ovarian carcinoma (FIGO IIIB-IV) is effective and safe.The primary outcome was the proportion of complete cytoreductions. The secondary outcomes were: complication rate, proportion of colostomies applied, histological findings, disease-free survival and overall survival.Five case series or reports were found, including a total of 77 patients with FIGO stage IIIC-IV ovarian cancer in whom the PlasmaJet® device was used for primary or interval debulking. Complete cytoreduction was obtained in 79% of the patients. Apart from one pneumothorax after extensive surgery, but no harm or additional complications related to the use of the PlasmaJet® Device were reported. Data on disease-free survival or overall survival were not reported.These findings suggest that the PlasmaJet® Device is an efficient and safe innovative surgical device for debulking surgery with encouraging results. We have proposed an RCT in which we will compare feasibility, safety and effectiveness aspects of the use of the PlasmaJet® versus conventional electrosurgery in advanced stage epithelial ovarian cancer (FIGO IIIB-IV).


Carcinoma, Ovarian Epithelial/surgery , Cytoreduction Surgical Procedures/methods , Ovarian Neoplasms/surgery , Carcinoma, Ovarian Epithelial/diagnosis , Carcinoma, Ovarian Epithelial/mortality , Cytoreduction Surgical Procedures/instrumentation , Female , Humans , Neoplasm Staging , Ovarian Neoplasms/diagnosis , Ovarian Neoplasms/mortality , Prognosis , Treatment Outcome
11.
Surg Endosc ; 33(9): 2991-3000, 2019 09.
Article En | MEDLINE | ID: mdl-30421076

INTRODUCTION: While minimally invasive left pancreatectomy has become more widespread and generally accepted over the last decade, opinions on modality of minimally invasive approach (robotic or laparoscopic) remain mixed with few institutions performing a significant portion of both operative approaches simultaneously. METHODS: 247 minimally invasive left pancreatectomies were retrospectively identified in a prospectively maintained institutional REDCap™ database, 135 laparoscopic left pancreatectomy (LLP) and 108 robotic-assisted left pancreatectomy (RLP). Demographics, intraoperative variables, postoperative outcomes, and OR costs were compared between LLP and RLP with an additional subgroup analysis for procedures performed specifically for pancreatic adenocarcinoma (35 LLP and 23 RLP) focusing on pathologic outcomes and 2-year actuarial survival. RESULTS: There were no significant differences in preoperative demographics or indications between LLP and RLP with 34% performed for chronic pancreatitis and 23% performed for pancreatic adenocarcinoma. While laparoscopic cases were faster (p < 0.001) robotic cases had a higher rate of splenic preservation (p < 0.001). Median length of stay was 5 days for RLP and LLP, and rate of clinically significant grade B/C pancreatic fistula was approximately 20% for both groups. Conversion rates to laparotomy were 4.3% and 1.8% for LLP and RLP approaches respectively. RLP had a higher rate of readmission (p = 0.035). Pathologic outcomes and 2-year actuarial survival were similar between LLP and RLP. LLP on average saved $206.67 in OR costs over RLP. CONCLUSIONS: This study demonstrates that at a high-volume center with significant minimally invasive experience, both LLP and RLP can be equally effective when used at the discretion of the operating surgeon. We view the laparoscopic and robotic platforms as tools for the modern surgeon, and at our institution, given the technical success of both operative approaches, we will continue to encourage our surgeons to approach a difficult operation with their tool of choice.


Cytoreduction Surgical Procedures , Laparoscopy , Pancreatectomy , Pancreatic Neoplasms , Pancreatitis, Chronic/surgery , Robotic Surgical Procedures , Cytoreduction Surgical Procedures/adverse effects , Cytoreduction Surgical Procedures/instrumentation , Cytoreduction Surgical Procedures/methods , Female , Hospitals, High-Volume/statistics & numerical data , Humans , Laparoscopy/adverse effects , Laparoscopy/methods , Length of Stay , Male , Middle Aged , Outcome and Process Assessment, Health Care , Pancreatectomy/adverse effects , Pancreatectomy/instrumentation , Pancreatectomy/methods , Pancreatic Neoplasms/pathology , Pancreatic Neoplasms/surgery , Retrospective Studies , Robotic Surgical Procedures/adverse effects , Robotic Surgical Procedures/methods , Pancreatic Neoplasms
12.
J Cosmet Dermatol ; 17(6): 960-967, 2018 Dec.
Article En | MEDLINE | ID: mdl-30225926

BACKGROUND: Rhinophyma is a cosmetically deforming disease characterized by nodular overgrowth of the lower 2/3 of the nose and is considered the end stage of acne rosacea. AIMS: Review the spectrum of procedural techniques for treatment of rhinophyma with a focus on the advantages and disadvantages of each modality. METHODS: A comprehensive literature search was conducted using the search terms "rhinophyma," "treatment," and "surgery" in PubMed. Case reports, case series, and small retrospective trials using procedural techniques for management of rhinophyma were included for review. Animal studies, non-English articles, and reports of medical treatment of rhinophyma were excluded. RESULTS: There are currently no prospective, randomized controlled studies evaluating procedural management of rhinophyma. The most commonly employed treatments include scalpel excision, resection with heated knives, dermabrasion, electrosurgery and lasers, specifically carbon dioxide (CO2 ) and erbium:yttrium-aluminum-garnet (Er:YAG). The main complication associated with complete excision of rhinophymatous tissue is excessive scarring. To correct for this adverse effect, partial or tangential excision with preservation of underlying adnexal structures is now the accepted technique, irrespective of the chosen modality. CONCLUSION: There is no accepted gold standard for management of rhinophyma, and each modality succeeds in maintaining hemostasis, reducing scarring and achieving satisfactory cosmesis to different degrees. There is a conflicting data on the theoretical risk of recurrence with partial excision due to incomplete removal of tissue. Further studies evaluating this risk and alternate methods of prevention are required.


Cytoreduction Surgical Procedures/methods , Dermatologic Surgical Procedures/methods , Rhinophyma/surgery , Rhinoplasty/methods , Cytoreduction Surgical Procedures/instrumentation , Dermabrasion , Dermatologic Surgical Procedures/instrumentation , Electrosurgery , Humans , Lasers, Gas/therapeutic use , Recurrence , Rhinoplasty/instrumentation
13.
Rev Col Bras Cir ; 45(4): e1909, 2018 Aug 20.
Article Pt, En | MEDLINE | ID: mdl-30133548

Peritoneal carcinomatosis is the natural course of gastrointestinal, gynecologic, and primary peritoneal neoplasms. In recent years, our understanding of carcinomatosis has changed; it is no longer considered a disseminated condition, but rather a disease confined to the peritoneum. Thus, the combination of cytoreductive surgery and intraperitoneal chemotherapy has become the cornerstone of control of peritoneal metastases. Traditionally, intraperitoneal chemotherapy is delivered in the form of liquid solutions. However, a new mode of chemotherapy delivery to the abdominal cavity has arisen as an alternative to the conventional method. In Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC), the liquid solution is aerosolized into a spray, potentiating the distribution and penetration of the chemotherapeutic agent intraperitoneally. The present study aims to describe a novel form of this innovative surgical technique performed for the first time in Brazil, in a modification of the technique originally described for PIPAC: delivery through a single-port device.


A carcinomatose peritoneal é a evolução natural das neoplasias gastrointestinais, ginecológicas e primárias do peritônio. Nos últimos anos, a carcinomatose passou a ser considerada uma doença confinada ao peritônio, e não mais uma doença disseminada. Desta forma, a associação de citorredução cirúrgica associada à quimioterapia intraperitoneal se tornou o ponto chave no controle das metástases peritoneais. Tradicionalmente, a quimioterapia intraperitoneal é aplicada utilizando soluções líquidas. Uma nova modalidade de infusão da quimioterapia na cavidade abdominal surge como uma alternativa ao método tradicional. A chamada PIPAC (Pressurized Intraperitoneal Aerosol Chemotherapy) transforma a solução terapêutica líquida em um spray aerossolizado, potencializando a distribuição e penetração da quimioterapia intraperitoneal. Este relato tem por objetivo descrever essa nova técnica cirúrgica inovadora, realizada pela primeira vez por um monoportal no Brasil, alterando a forma descrita originalmente para a aplicação da PIPAC.


Antineoplastic Agents/administration & dosage , Cytoreduction Surgical Procedures/standards , Palliative Care/standards , Peritoneal Neoplasms/surgery , Aerosols/administration & dosage , Cytoreduction Surgical Procedures/instrumentation , Cytoreduction Surgical Procedures/methods , Humans , Operating Rooms/standards , Palliative Care/methods , Peritoneal Neoplasms/secondary , Pressure
15.
Medicine (Baltimore) ; 97(11): e0095, 2018 Mar.
Article En | MEDLINE | ID: mdl-29538201

RATIONALE: Salivary duct carcinoma (SDC) is a rare and aggressive subtype of salivary gland carcinoma that histologically resembles in situ and invasive ductal carcinoma of the breast. We present the first case of advanced SDC of the minor salivary gland arising from the supraglottis and review the literature on the clinicopathologic characteristics and prognosis of SDC. PATIENT CONCERNS: A 59-year-old male patient with progressive difficulty in swallowing and a muffled voice for 2 months. DIAGNOSES: The patient was diagnosed with SDC arising from the supraglottis with extensive tumor invasion into the subsites of the larynx and pharynx. INTERVENTIONS: Due to impending airway obstruction, the patient underwent CO2 laser debulking surgery. In addition to local disease, lymph node and distant metastases were also noted at diagnosis and concurrent chemoradiation therapy was arranged. OUTCOMES: Laryngeal function was preserved and tracheostomy was avoided. The patient has survived for >1 year after the initial diagnosis. LESSONS: SDC is a rare and aggressive subtype of salivary gland carcinoma that histologically resembles in situ and invasive ductal carcinoma of the breast. Here we presented the first case of advanced SDC of the minor salivary gland arising from the supraglottis that was treated with CO2 laser debulking surgery followed by concurrent chemoradiation therapy. Due to their rarity, further studies are required to establish the most effective treatment protocol for advanced SDC.


Carcinoma , Chemoradiotherapy/methods , Cytoreduction Surgical Procedures , Larynx , Salivary Ducts/pathology , Salivary Gland Neoplasms , Salivary Glands, Minor/pathology , Airway Obstruction/etiology , Airway Obstruction/surgery , Carcinoma/pathology , Carcinoma/physiopathology , Carcinoma/therapy , Cytoreduction Surgical Procedures/instrumentation , Cytoreduction Surgical Procedures/methods , Humans , Larynx/pathology , Larynx/physiopathology , Larynx/surgery , Lasers, Gas/therapeutic use , Lymphatic Metastasis/pathology , Male , Middle Aged , Neoplasm Invasiveness , Neoplasm Staging , Salivary Gland Neoplasms/pathology , Salivary Gland Neoplasms/physiopathology , Salivary Gland Neoplasms/therapy , Treatment Outcome
16.
Head Neck ; 40(4): 837-841, 2018 04.
Article En | MEDLINE | ID: mdl-29360235

BACKGROUND: Most retrosternal goiter surgical removal can be performed via a transcervical approach. However, it is often a challenging procedure, which might include sternotomy. METHODS: We describe a surgical technique using a microdebrider for intracapsular volume reduction that precedes an extracapsular thyroidectomy, thereby avoiding the need for sternotomy, with decreased morbidity and risk. The procedure is described in detail with 2 representative cases and a summary of our experience in 26 cases. RESULTS: Twenty-six patients with retrosternal goiters are included in our cohort. None of the patients needed a sternotomy, and no major or permanent complications occurred. The average length of hospital stay was 4.30 days after total thyroidectomy and 2.57 days after hemithyroidectomy. CONCLUSION: The use of a microdebrider for intracapsular volume reduction thyroidectomy is extremely helpful for transcervical removal of retrosternal goiters in selected cases, and avoids the need for sternotomy, which is especially beneficial in elderly patients, and those with comorbidities for whom sternotomy should be avoided.


Cytoreduction Surgical Procedures/instrumentation , Goiter, Substernal/diagnostic imaging , Goiter, Substernal/surgery , Sternotomy/methods , Thyroidectomy/methods , Aged , Aged, 80 and over , Cohort Studies , Cytoreduction Surgical Procedures/methods , Female , Follow-Up Studies , Humans , Male , Middle Aged , Preoperative Care/methods , Retrospective Studies , Risk Assessment , Severity of Illness Index , Tomography, X-Ray Computed/methods , Treatment Outcome
18.
Rev. Col. Bras. Cir ; 45(4): e1909, 2018. graf
Article Pt | LILACS | ID: biblio-956574

RESUMO A carcinomatose peritoneal é a evolução natural das neoplasias gastrointestinais, ginecológicas e primárias do peritônio. Nos últimos anos, a carcinomatose passou a ser considerada uma doença confinada ao peritônio, e não mais uma doença disseminada. Desta forma, a associação de citorredução cirúrgica associada à quimioterapia intraperitoneal se tornou o ponto chave no controle das metástases peritoneais. Tradicionalmente, a quimioterapia intraperitoneal é aplicada utilizando soluções líquidas. Uma nova modalidade de infusão da quimioterapia na cavidade abdominal surge como uma alternativa ao método tradicional. A chamada PIPAC (Pressurized Intraperitoneal Aerosol Chemotherapy) transforma a solução terapêutica líquida em um spray aerossolizado, potencializando a distribuição e penetração da quimioterapia intraperitoneal. Este relato tem por objetivo descrever essa nova técnica cirúrgica inovadora, realizada pela primeira vez por um monoportal no Brasil, alterando a forma descrita originalmente para a aplicação da PIPAC.


ABSTRACT Peritoneal carcinomatosis is the natural course of gastrointestinal, gynecologic, and primary peritoneal neoplasms. In recent years, our understanding of carcinomatosis has changed; it is no longer considered a disseminated condition, but rather a disease confined to the peritoneum. Thus, the combination of cytoreductive surgery and intraperitoneal chemotherapy has become the cornerstone of control of peritoneal metastases. Traditionally, intraperitoneal chemotherapy is delivered in the form of liquid solutions. However, a new mode of chemotherapy delivery to the abdominal cavity has arisen as an alternative to the conventional method. In Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC), the liquid solution is aerosolized into a spray, potentiating the distribution and penetration of the chemotherapeutic agent intraperitoneally. The present study aims to describe a novel form of this innovative surgical technique performed for the first time in Brazil, in a modification of the technique originally described for PIPAC: delivery through a single-port device.


Humans , Palliative Care/standards , Peritoneal Neoplasms/surgery , Cytoreduction Surgical Procedures/standards , Antineoplastic Agents/administration & dosage , Operating Rooms/standards , Palliative Care/methods , Peritoneal Neoplasms/secondary , Pressure , Aerosols/administration & dosage , Cytoreduction Surgical Procedures/instrumentation , Cytoreduction Surgical Procedures/methods
19.
Cardiovasc Intervent Radiol ; 40(7): 964-977, 2017 Jul.
Article En | MEDLINE | ID: mdl-28451812

Traditional percutaneous balloon angioplasty and stent placement is based on mechanical plaque disruption and displacement within the arterial wall. On the contrary, transcatheter atherectomy achieves atherosclerotic plaque clearance by means of directional plaque excision or rotational plaque removal or laser plaque ablation. Debulking atherectomy may allow for a more uniform angioplasty result at lower pressures with consequently less vessel barotrauma and improved luminal gain, thereby decreasing the risk of plaque recoil and dissection that may require permanent metal stenting. It has been also argued that atherectomy may disrupt the calcium barrier and optimize drug transfer and delivery in case of drug-coated balloon applications. The authors discuss the various types of atherectomy devices available in clinical practice to date and critically appraise their mode of action as well as relevant published data in each case. Overall, amassed randomized and observational evidence indicates that percutaneous atherectomy of the femoropopliteal and infrapopliteal arteries may achieve high technical success rates and seems to lessen the frequency of bailout stenting, however, at the expense of increased risk of peri-procedural distal embolization. Long-term clinical outcomes reported to date do not support the superiority of percutaneous atherectomy over traditional balloon angioplasty and stent placement in terms of vessel patency or limb salvage. The combination of debulking atherectomy and drug-coated balloons has shown promise in early studies, especially in the treatment of more complex lesions. Unanswered questions and future perspectives of this continuously evolving endovascular technology as part of a broader treatment algorithm are discussed.


Atherectomy/instrumentation , Cytoreduction Surgical Procedures/instrumentation , Endovascular Procedures/instrumentation , Peripheral Vascular Diseases/surgery , Algorithms , Equipment Design , Femoral Artery/surgery , Humans , Limb Salvage/instrumentation , Randomized Controlled Trials as Topic , Stents , Vascular Patency
20.
Int J Gynecol Cancer ; 27(1): 177-182, 2017 01.
Article En | MEDLINE | ID: mdl-27922979

OBJECTIVES: Complete cytoreduction of ovarian cancer often requires excision or ablation of bowel serosa implants. Both argon beam coagulator (ABC) and thermal plasma energy (TPE) (PlasmaJet; PlasmaSurgical, Roswell, Ga) have been used to ablate bowel serosa implants. Our objective was to identify comparable power settings as well as determine the rate of bowel perforation, depth of thermal injury, and extent of inflammatory response with ABC versus TPE in a porcine model. MATERIALS AND METHODS: Nine pigs underwent vaporization of small bowel and colon serosa according to assigned treatment group (TPE vs ABC) and settings (ABC: 30, 50, and 70 W; TPE: Cut 10U, 20U, and 30U and Coagulation 10U, 20U, and 30U). Animals underwent necropsy with blinded histomorphologic evaluation on days 0, 3, and 10 postprocedure to assess for presence of bowel perforation, depth of thermal injury, and extent of inflammatory response. RESULTS: At necropsy, bowel perforation was not identified in any animals. Depth of treatment with ABC in the porcine colon was variable and unrelated to power settings whereas TPE was associated with a consistent treatment depth of 1.0 mm regardless of location or power. Treatment with ABC resulted in greater tissue coagulation and desiccation as well as increased rates of mucosal necrosis, especially at higher settings (>50 W). Treatment with TPE primarily resulted in tissue ablation and minimal mucosal necrosis at low settings (Coag 10U-20U). The inflammatory response associated with TPE treatments was interpreted as biologically benign, and less than that observed with the ABC regardless of treatment settings. CONCLUSIONS: Both ABC and TPE effectively ablate bowel serosa in a porcine model. The TPE seems to result in a more predictable tissue effect with less inflammatory response, especially when used at low power settings such as Coag 10U or 20U. These characteristics are appealing for ablation of bowel serosa implants during ovarian cancer surgery and warrant further investigation.


Cytoreduction Surgical Procedures/instrumentation , Intestine, Small/surgery , Laser Coagulation/instrumentation , Laser Therapy/instrumentation , Plasma Gases/therapeutic use , Animals , Argon Plasma Coagulation/adverse effects , Argon Plasma Coagulation/instrumentation , Argon Plasma Coagulation/methods , Cytoreduction Surgical Procedures/adverse effects , Cytoreduction Surgical Procedures/methods , Female , Intestinal Mucosa/surgery , Laser Coagulation/adverse effects , Laser Therapy/adverse effects , Laser Therapy/methods , Models, Animal , Swine
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