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1.
Ann Surg ; 279(1): 172-179, 2024 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-36928294

RESUMO

OBJECTIVE: To determine the relationship between race/ethnicity and case volume among graduating surgical residents. BACKGROUND: Racial/ethnic minority individuals face barriers to entry and advancement in surgery; however, no large-scale investigations of the operative experience of racial/ethnic minority residents have been performed. METHODS: A multi-institutional retrospective analysis of the Accreditation Council for Graduate Medical Education case logs of categorical general surgery residents at 20 programs in the US Resident OPerative Experience Consortium database was performed. All residents graduating between 2010 and 2020 were included. The total, surgeon chief, surgeon junior, and teaching assistant case volumes were compared between racial/ethnic groups. RESULTS: The cohort included 1343 residents. There were 211 (15.7%) Asian, 65 (4.8%) Black, 73 (5.4%) Hispanic, 71 (5.3%) "Other" (Native American or Multiple Race), and 923 (68.7%) White residents. On adjusted analysis, Black residents performed 76 fewer total cases (95% CI, -109 to -43, P <0.001) and 69 fewer surgeon junior cases (-98 to -40, P <0.001) than White residents. Comparing adjusted total case volume by graduation year, both Black residents and White residents performed more cases over time; however, there was no difference in the rates of annual increase (10 versus 12 cases per year increase, respectively, P =0.769). Thus, differences in total case volume persisted over the study period. CONCLUSIONS: In this multi-institutional study, Black residents graduated with lower case volume than non-minority residents throughout the previous decade. Reduced operative learning opportunities may negatively impact professional advancement. Systemic interventions are needed to promote equitable operative experience and positive culture change.


Assuntos
Cirurgia Geral , Internato e Residência , Humanos , Estudos Retrospectivos , Etnicidade , Competência Clínica , Grupos Minoritários , Educação de Pós-Graduação em Medicina , Cirurgia Geral/educação
2.
J Surg Res ; 293: 613-617, 2024 01.
Artigo em Inglês | MEDLINE | ID: mdl-37837816

RESUMO

INTRODUCTION: Lymphoscintigraphy (LS) helps identify drainage to interval (epitrochlear or popliteal) lymph node basins for extremity melanomas. This study evaluated how often routine LS evaluation identified an interval sentinel lymph node (SLN) and how often that node was found to have metastasis. METHODS: A single institution, retrospective study identified patients with an extremity melanoma who underwent routine LS and SLN biopsy over a 25-y period. Comparisons of factors associated with the identification of interval node drainage and tumor status were made. RESULTS: In 634 patients reviewed, 5.7% of patients drained to an interval SLN. Of those biopsied, 29.2% were positive for micrometastases. Among patients with biopsies of both the traditional and interval nodal basins, nearly 20% had positive interval nodes with negative SLNs in the traditional basin. Sex, age, thickness, ulceration, and the presence of mitotic figures were not predictive of identifying an interval node on LS, nor for having disease in an interval node. Anatomic location of the primary melanoma was the only identifiable risk factor, as no interval nodes were identified in melanomas of the thigh or upper arm (P ≤ 0.001). CONCLUSIONS: Distal extremity melanomas have a moderate risk of mapping to an interval SLN. Routine LS should be considered in these patients, especially as these may be the only tumor-positive nodes. However, primary extremity melanomas proximal to the epitrochlear or popliteal nodal basins do not map to interval nodes, and improved savings and workflow could be realized by selectively omitting routine LS in such patients.


Assuntos
Linfadenopatia , Melanoma , Linfonodo Sentinela , Neoplasias Cutâneas , Humanos , Linfonodo Sentinela/diagnóstico por imagem , Linfonodo Sentinela/patologia , Linfocintigrafia , Estudos Retrospectivos , Metástase Linfática/diagnóstico por imagem , Metástase Linfática/patologia , Cintilografia , Neoplasias Cutâneas/diagnóstico por imagem , Neoplasias Cutâneas/cirurgia , Neoplasias Cutâneas/patologia , Melanoma/diagnóstico por imagem , Melanoma/cirurgia , Melanoma/patologia , Linfonodos/patologia , Biópsia de Linfonodo Sentinela , Extremidade Superior/diagnóstico por imagem , Excisão de Linfonodo , Melanoma Maligno Cutâneo
3.
J Surg Oncol ; 2024 Jun 03.
Artigo em Inglês | MEDLINE | ID: mdl-38828742

RESUMO

BACKGROUND: Neoadjuvant chemotherapy (NAC) use for pancreatic ductal adenocarcinoma (PDAC) has increased, but some patients never get resection following NAC. METHODS: Data from January 2012 to December 2019 for all clinically resectable patients across two health networks were utilized, as well as data from the ACS NCDB registry. Univariate testing, multivariable logistic regression, and survival analyses were employed to evaluate failure to resection after neo-adjuvant chemotherapy. RESULTS: Of the 10 007 registry patients eligible for resection, the resected group was younger (64.6 vs. 69.5 years; p < 0.001) and had a slightly lower mean comorbidity index (0.41 vs. 0.45; p < 0.001) than the nonsurgical group. The nonsurgical group was composed of a higher percentage of Black and Hispanic patients (17.5 vs. 13.1%; p < 0.001). After adjusting for age and comorbidities, the factors associated with decreased probability of resection after NAC were evaluation at a community hospital (OR 2.4), Black or Hispanic race (OR 1.6), areas of increased high school drop-out rates (OR 1.4), and lack of private health insurance (OR 1.3). The median overall survival for nonsurgery was markedly worse than the surgical cohort (10.6 vs. 26.6 months; p < 0.001). The most frequent reasons for a lack of definitive resection were operative upstaging to unresectable (39.6%), patient preference (14.5%), progression on NAC (13.2%), deconditioning or comorbidity severity (12.5%), and nonreferral to a surgeon (8.8%). CONCLUSIONS: Racial, economic, and educational disparities have a considerable influence on the successful completion of a neoadjuvant approach for resectable PDAC. A comprehensive closed or highly collaborative/communicative multidisciplinary neoadjuvant program is optimal for treatment success and completion.

4.
Surg Endosc ; 38(2): 742-756, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38049669

RESUMO

BACKGROUND: Post-operative pancreatic fistula (POPF) is a major complication following pancreatectomy and is currently difficult to predict pre-operatively. This study aims to validate pre-operative risk factors and develop a novel combined score for the prediction of POPF in the pre-operative setting. METHODS: Data were collected from 2016 to 2021 for radiologic main pancreatic duct diameter (MPD), body mass index (BMI), physical status classified by American Society of Anesthesiologists (ASA), polypharmacy, mean platelet ratio (MPR), comorbidity-polypharmacy score (CPS), and a novel Combined Pancreatic Leak Prediction Score (CPLPS) (derived from MPD diameter, BMI, and CPS) were obtained from pre-operative data and analyzed for their independent association with POPF occurrence. RESULTS: In total, 166 patients who underwent pancreatectomy with pancreatic leak (Grade A, B, and C) occurring in 51(30.7%) of patients. Pre-operative radiologic MPD diameter < 4 mm (p < 0.001), < 5 mm (p < 0.001), < 6 mm (p = 0.001), BMI ≥ 25 (p = 0.009), and ≥ 30 (p = 0.017) were independently associated with the occurrence of pancreatic leak. CPLPS was also predictive of pancreatic leak following pancreatectomy on univariate (p = 0.005) and multivariate analysis (p = 0.036). CONCLUSION: MPD and BMI were independent risk factors predictive for the development of pancreatic leak. CPLPS, was an independent predictor of pancreatic leak following pancreatectomy and could be used to help guide surgical decision making and patient counseling.


Assuntos
Pancreatectomia , Pancreaticoduodenectomia , Humanos , Pancreatectomia/efeitos adversos , Pancreaticoduodenectomia/efeitos adversos , Pâncreas/cirurgia , Fatores de Risco , Fístula Pancreática/diagnóstico , Fístula Pancreática/etiologia , Fístula Pancreática/epidemiologia , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Estudos Retrospectivos
5.
Ann Surg ; 278(1): 1-7, 2023 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-36994704

RESUMO

OBJECTIVE: To examine differences in resident operative experience between male and female general surgery residents. BACKGROUND: Despite increasing female representation in surgery, sex and gender disparities in residency experience continue to exist. The operative volume of male and female general surgery residents has not been compared on a multi-institutional level. METHODS: Demographic characteristics and case logs were obtained for categorical general surgery graduates between 2010 and 2020 from the US Resident OPerative Experience Consortium database. Univariable, multivariable, and linear regression analyses were performed to compare differences in operative experience between male and female residents. RESULTS: There were 1343 graduates from 20 Accreditation Council for Graduate Medical Education-accredited programs, and 476 (35%) were females. There were no differences in age, race/ethnicity, or proportion pursuing fellowship between groups. Female graduates were less likely to be high-volume residents (27% vs 36%, P < 0.01). On univariable analysis, female graduates performed fewer total cases than male graduates (1140 vs 1177, P < 0.01), largely due to a diminished surgeon junior experience (829 vs 863, P < 0.01). On adjusted multivariable analysis, female sex was negatively associated with being a high-volume resident (OR = 0.74, 95% CI: 0.56 to 0.98, P = 0.03). Over the 11-year study period, the annual total number of cases increased significantly for both groups, but female graduates (+16 cases/year) outpaced male graduates (+13 cases/year, P = 0.02). CONCLUSIONS: Female general surgery graduates performed significantly fewer cases than male graduates. Reassuringly, this gap in operative experience may be narrowing. Further interventions are warranted to promote equitable training opportunities that support and engage female residents.


Assuntos
Cirurgia Geral , Internato e Residência , Cirurgiões , Humanos , Masculino , Feminino , Competência Clínica , Educação de Pós-Graduação em Medicina , Etnicidade , Cirurgia Geral/educação
6.
J Surg Oncol ; 128(4): 531-539, 2023 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-37165984

RESUMO

BACKGROUND: Intraoperative bile cultures (IOBCs) taken during pancreatic surgery are commonly performed and there has been limited evidence that a positive IOBC could aid in perioperative adverse event (AE) management. Therefore, this study aims to describe infection management in patients undergoing irreversible electroporation (IRE). METHODS: An Institutional Review Board (IRB)-approved prospective database was utilized from 8/2016 to 6/2022, with 127 pancreatic adenocarcinoma patients included. RESULTS: A total of 28 patients that underwent IRE also had a simultaneous positive IOBC and the remaining 99 patients that underwent IRE had negative IOBC. A total of 11(39%) of the patients with a positive IOBC had AE's, and 38 (38%) of the patients with negative IOBC had AE's. Both groups had similar rates of AEs leading to new hospitalization and prolonged hospitalizations. Overall, there was no correlation between a positive IOBC and a patient developing an AE. CONCLUSIONS: The findings of this study provide insights that improve the infectious management of patients undergoing IRE.


Assuntos
Adenocarcinoma , Segunda Neoplasia Primária , Neoplasias Pancreáticas , Humanos , Neoplasias Pancreáticas/cirurgia , Neoplasias Pancreáticas/patologia , Adenocarcinoma/cirurgia , Adenocarcinoma/patologia , Resultado do Tratamento , Pâncreas/patologia , Eletroporação
7.
Int J Clin Oncol ; 28(4): 565-575, 2023 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-36745265

RESUMO

BACKGROUND: The optimal access for thermal ablation of the liver has not been evaluated in the literature for the laparoscopic versus percutaneous techniques. The aim of this manuscript was to determine the optimal ablation technique and patient selection for hepatic malignancies by comparing the efficacy and recurrence-free survival of laparoscopic and percutaneous thermal ablation. METHODS: A detailed literature search was made in PubMed, Web of Science, Google scholar, and EMBASE for related research publications. The data were extracted and assessed by two reviewers independently. Analysis of pooled data was performed, and Odds Ratio (OR) or Hazard Ratio (HR) with corresponding confidence intervals (CIs) was calculated and summarized respectively. RESULTS: A total of 10 articles were included with 1916 ablation patients. Laparoscopic ablation success (Median 100%) was found to be higher than percutaneous ablation success (median 89.4%) (p = ns). There was a higher percentage of both local and non-local hepatic recurrence in the patients treated with percutaneous ablation versus laparoscopic ablation. Meta-analysis indicated no difference in the adjusted hazard rate of recurrence by procedure type (p = 0.94). Laparoscopic ablation had a higher percentage of complications compared to percutaneous ablation (median lap 14.5% vs. perc 3.3%). CONCLUSIONS: While laparoscopic and percutaneous ablation are both effective interventions for hepatic malignancies, laparoscopic ablation was found to have improved ablation success and less local and non-local hepatic recurrence compared to percutaneous ablation.


Assuntos
Carcinoma Hepatocelular , Ablação por Cateter , Laparoscopia , Neoplasias Hepáticas , Humanos , Carcinoma Hepatocelular/patologia , Ablação por Cateter/métodos , Neoplasias Hepáticas/patologia
8.
Ann Surg Oncol ; 29(9): 5462-5473, 2022 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-35657463

RESUMO

BACKGROUND: Unresectable intrahepatic cholangiocarcinoma (ICC) carries a poor prognosis, and currently there are moderately established chemotherapeutic [gemcitabine/cisplatin (Gem/Cis)] treatments to prolong survival. The purpose of this study was to assess the efficacy of irinotecan drug-eluting beads (DEBIRI) therapy by transarterial infusion in combination with systemic therapy in unresectable ICC. PATIENTS AND METHODS: This is a prospective, multicenter, open-label, randomized phase II study (Clin Trials: NCT01648023-DELTIC trial) of patients with ICC randomly assigned to Gem/Cis with DEBIRI or Gem/Cis alone. The primary endpoint was response rate. RESULTS: The intention-to-treat population comprised 48 patients: 24 treated with Gem/Cis and DEBIRI and 22 with Gem/Cis alone (2 screen failures). The two groups were similar with respect to the extent of liver involvement (35% versus 38%) and presence of extrahepatic disease (29% versus 14%, p = 0.12). Median numbers of chemotherapy cycles were similar (6 versus 6), as were rates of grade 3/4 adverse events (34% for the Gem/Cis-DEBIRI group versus 36% for the Gem/Cis group). The overall response rate was significantly greater in the Gem/Cis-DEBIRI arm versus the Gem/Cis arm at 2 (p < 0.04), 4 (p < 0.03), and 6 months (p < 0.05). There was significantly more downsizing to resection/ablation in the Gem/Cis-DEBIRI arm versus the Gem/Cis arm (25% versus 8%, p < 005), and there was improved median progression-free survival [31.9 (95% CI 8.5-75.3) months versus 10.1 (95% CI 5.3-13.5) months, p = 0.028] and improved overall survival [33.7 (95% CI 13.5-54.5) months versus 12.6 (95% CI 8.7-33.4) months, p = 0.048]. CONCLUSION: Combination Gem/Cis with DEBIRI is safe, and leads to significant improvement in downsizing to resection, improved progression-free survival, and overall survival.


Assuntos
Neoplasias dos Ductos Biliares , Colangiocarcinoma , Neoplasias Hepáticas , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias dos Ductos Biliares/tratamento farmacológico , Neoplasias dos Ductos Biliares/etiologia , Ductos Biliares Intra-Hepáticos , Camptotecina , Colangiocarcinoma/tratamento farmacológico , Cisplatino/uso terapêutico , Desoxicitidina/análogos & derivados , Humanos , Irinotecano/uso terapêutico , Estudos Prospectivos , Resultado do Tratamento , Gencitabina
9.
HPB (Oxford) ; 24(10): 1789-1795, 2022 10.
Artigo em Inglês | MEDLINE | ID: mdl-35491339

RESUMO

BACKGROUND: The aim of this study is to present radiologically designated LAPC found to be resectable upon surgical exploration and evaluate the outcomes of such resections. METHODS: Sequential LAPC patients between 2013 and 2019 were staged and underwent resection were included in the analysis of both perioperative and long-term outcomes. RESULTS: Twenty-eight patients with radiologically-designated LAPC underwent surgical resection after chemotherapy with a median follow-up of 31.7 m,75% underwent pancreaticoduodenectomy. The margin positivity and local recurrence rates were 21.4% and 35.7%, respectively. When compared to the 30 BRPC controls, the LAPC group had a higher rates of an arterial resection (11vs.1; p = 0.002), but the groups were similar with regard to all other preoperative and intraoperative variables (p < 0.05). Perioperative morbidity rates were similar (25.9%vs21.4%; p = 0.53). The LAPC and BRPC groups were also equivalent with respect to median recurrence-free survival (9.0mo; 95%CI 6.3, 11.7vs.8.3mo; 95%CI 5.4, 11.2) and median overall survival (19.9mo; 95%CI 17.0, 22.7 vs. 19.9mo; 95%CI 14.8, 25.1), respectively. CONCLUSION: Despite a radiologic designation of locally advanced pancreatic cancer, certain subtypes of LAPC warrant surgical exploration provided the operative surgeon is prepared for major arterial and/or venous resection. Pancreatectomy in these patients has acceptable morbidity and oncologic outcomes, similar to patients who are radiologically borderline resectable.


Assuntos
Neoplasias Pancreáticas , Humanos , Neoplasias Pancreáticas/diagnóstico por imagem , Neoplasias Pancreáticas/cirurgia , Neoplasias Pancreáticas/tratamento farmacológico , Terapia Neoadjuvante , Pancreatectomia/efeitos adversos , Pancreatectomia/métodos , Pancreaticoduodenectomia/efeitos adversos , Contraindicações
10.
Ann Surg Oncol ; 28(8): 4173-4180, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-33586072

RESUMO

Locally advanced pancreatic cancer (LAPC) is a challenging disease to treat. There is consensus that systemic chemotherapy should be the first line of therapy for most patients. However, there is no consensus on how to manage those patients who do not have sufficient response to become candidates for resection but also do not have distant progression after weeks or months of systemic therapy. Radiation therapy is the most commonly used and best-studied local ablative therapy. One recent randomized controlled trial (LAP-07) failed to demonstrate an overall survival benefit for conventional chemoradiation therapy after induction chemotherapy versus chemotherapy alone. This study had several limitations, and ongoing studies are re-evaluating the role of chemoradiation after more effective chemotherapy regimens as well as more advanced radiation techniques. In parallel, there has been increasing interest in other thermal and non-thermal methods of ablation. In particular, irreversible electroporation has gained traction for treatment of LAPC, with at least one ongoing randomized controlled trial designed to address its role compared with systemic chemotherapy alone. Multiple preclinical and clinical studies are investigating combinations of local ablation and immunotherapy with the goal of generating immune responses that will meaningfully improve outcomes.


Assuntos
Neoplasias Pancreáticas , Quimiorradioterapia , Eletroporação , Humanos , Quimioterapia de Indução , Pâncreas , Neoplasias Pancreáticas/tratamento farmacológico
11.
Ann Surg Oncol ; 28(3): 1499-1510, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-33393028

RESUMO

Hepatocellular carcinoma (HCC), the most common primary hepatic malignancy worldwide, is the second leading cause of cancer-related death. Underlying liver dysfunction and advanced stage of disease require treatments to be optimally timed and implemented to minimize hepatic parenchymal damage while maximizing disease response and quality of life. Locoregional therapies (LRTs) such as trans-arterial chemo- and radio-embolization remain effective for intermediate liver-only and advanced HCC disease (i.e., Barcelona-Clinic liver cancer stages B and C) not amendable to primary resection or ablation. Additionally, these minimally invasive interventions have been shown to augment the immune system. This and the recent success of immune-oncologic treatments for HCC have generated interest in applying these therapies in combination with such locoregional interventions to improve patient outcomes and response rates. This report reviews the use of trans-arterial LRTs with immunotherapy for stages B and C HCC, potential biomarkers, and imaging methods for assessing the response and safety of such combinations.


Assuntos
Carcinoma Hepatocelular , Quimioembolização Terapêutica , Neoplasias Hepáticas , Carcinoma Hepatocelular/terapia , Humanos , Imunoterapia , Neoplasias Hepáticas/terapia , Qualidade de Vida
12.
Ann Surg Oncol ; 28(9): 4960-4966, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-33730227

RESUMO

BACKGROUND: The purpose of this study was to present the optimal patient selection for esophageal stenting after esophageal resection to investigate possible factors leading to treatment success or treatment failure in these patients. METHODS: This was a prospective, observational study of patients from January 2005 to May 2019 with an esophageal anastomotic leak that were treated with a self-expandable stent (SES). RESULTS: A total of 34 patients were treated. All achieved technical success (100%); 33 (97%) achieved clinical success. No patient had to have reoperative surgery based on their leak management. The stenting in-hospital mortality was 0% with 1 patient (2%) with a 90-day mortality from possible leak-related death. Patients had their stents removed with a median of 106 days. CONCLUSIONS: Stenting for an anastomotic leak after resection offers a safe and effective method of treatment and is successful in the majority of cases. Critical to success is optimal patient selection, adequate leak drainage, and optimal stent selection and placement.


Assuntos
Fístula Anastomótica , Esôfago , Fístula Anastomótica/cirurgia , Fístula Anastomótica/terapia , Humanos , Estudos Prospectivos , Reoperação , Estudos Retrospectivos , Stents , Resultado do Tratamento
13.
Ann Surg Oncol ; 28(11): 6201-6210, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-34089107

RESUMO

BACKGROUND: Locally-advanced pancreatic cancer (LAPC) is traditionally considered stage III unresectable disease. Advances in induction systemic therapy regimens, surgical technique, and perioperative care have led to successful resection of an increasing number of these tumors with reasonable perioperative outcomes and disease-free intervals. Certain anatomic characteristics that meet criteria for locally-advanced disease, however, are more likely to result in a successful surgical outcome. METHODS: A practical and consistent system is needed to communicate such nuance between surgical and nonsurgical oncologists for optimal treatment planning and to improve recording for cancer registries and research studies. RESULTS: The present study proposes a novel subclassification system for stage III pancreatic cancers based on their pattern of vascular involvement and examines the current evidence for resection in each scenario. Introducing needed detail into the current catch-all stage III categorization will help to direct patient referrals and increase the body of knowledge about the variable presentations of this complex malignancy. CONCLUSION: This proposed staging revision for LAPC is designed to convey more actionable tumor descriptions for treating oncologists, clinical trial eligibility, and surgical patient selection in the era of effective induction systemic therapy.


Assuntos
Segunda Neoplasia Primária , Neoplasias Pancreáticas , Humanos , Estadiamento de Neoplasias , Pâncreas/patologia , Neoplasias Pancreáticas/patologia , Neoplasias Pancreáticas/cirurgia
14.
BMC Cancer ; 21(1): 785, 2021 Jul 07.
Artigo em Inglês | MEDLINE | ID: mdl-34233640

RESUMO

BACKGROUND: Irreversible electroporation (IRE) is a local ablation technique utilizing high voltage, low energy direct current to create nanopores in cell membrane which disrupt homeostasis and leads to cell death. Previous reports have suggested IRE may have a role in treating borderline resectable and unresectable Stage 3 pancreatic tumors. METHODS: Patients with Stage 3 pancreatic ductal adenocarcinoma (PDAC) will be enrolled in either a randomized, controlled, multicenter trial (RCT) or a multicenter registry study. Subjects enrolled in the RCT must have no evidence of disease progression after 3 months of modified FOLFIRINOX (mFOLFIRINOX) treatment prior to being randomization to either a control or IRE arm. Post-induction and post-IRE treatment for the control and IRE arms, respectively, will be left to the discretion of the treating physician. The RCT will enroll 528 subjects with 264 per arm and include up to 15 sites. All subjects will be followed for at least 24 months or until death. The registry study will include two cohorts of patients with Stage 3 PDAC, patients who received institutional standard of care (SOC) alone and those treated with IRE in addition to SOC. Both cohorts will be required to have undergone at least 3 months of SOC without progression prior to enrollment. The registry study will enroll 532 patients with 266 patients in each arm. All patients will be followed for at least 24 months or until death. The primary efficacy endpoint for both studies will be overall survival (OS). Co-primary safety endpoints will be 1) time from randomization or enrollment in the registry to death or new onset of Grade 4 adverse event (AE), and (2 high-grade complications defined as any AE or serious AE (SAE) with a CTCAE v5.0 grade of 3 or higher. Secondary endpoints will include progression-free survival, cancer-related pain, quality of life, and procedure-related pain for the IRE arm only. DISCUSSION: These studies are intended to provide Level 1 clinical evidence and real-world data demonstrating the clinical utility and safety of the use of IRE in combination with chemotherapy in patients with Stage 3 PDAC. TRIAL REGISTRATION: Clinicaltrials.gov NCT03899636 and NCT03899649. Registered April 2, 2019. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) trial G180278 approved on May 3, 2019.


Assuntos
Técnicas de Ablação/métodos , Adenocarcinoma/cirurgia , Neoplasias Pancreáticas/cirurgia , Adenocarcinoma/mortalidade , Adenocarcinoma/patologia , Humanos , Neoplasias Pancreáticas/mortalidade , Neoplasias Pancreáticas/patologia , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Sistema de Registros , Análise de Sobrevida , Resultado do Tratamento
15.
World J Surg ; 45(3): 808-814, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-33230586

RESUMO

BACKGROUND: National guidelines suggest routine intraoperative esophagogastroduodenoscopy (EGD) during laparoscopic Heller myotomy (LHM) to assess for mucosal perforation and myotomy adequacy, but the utility of this is unknown. This study aimed to evaluate the effect of intraoperative EGD on outcomes after LHM. METHODS: Patients who underwent LHM in a single center were retrospectively identified. Outcomes were compared between patients who did and did not undergo intraoperative EGD. RESULTS: Sixty-one patients were reviewed: 46 (75%) underwent intraoperative EGD and 15 (25%) did not. Mucosal perforations occurred in 2 (4%) of the EGD group and 3 (20%) of the non-EGD group (p = 0.06). All perforations, regardless of EGD use, were recognized laparoscopically. There were no postoperative leaks. Failed myotomy occurred in 5 (11%) who underwent EGD and 1 (7%) who did not (p = 0.64). CONCLUSIONS: Because EGD does not appear to improve outcomes after LHM, we emphasize its selective, rather than routine, use.


Assuntos
Acalasia Esofágica , Miotomia de Heller , Laparoscopia , Endoscopia do Sistema Digestório , Acalasia Esofágica/diagnóstico , Acalasia Esofágica/cirurgia , Humanos , Complicações Pós-Operatórias , Estudos Retrospectivos , Resultado do Tratamento
16.
HPB (Oxford) ; 23(1): 63-70, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-32448647

RESUMO

BACKGROUND: The optimal timing of treatment of liver metastases from low-grade neuroendocrine tumors (LG-NELM) varies significantly due to numerous treatment modalities and the literature supporting various treatment(s). This study sought to create and validate a literature-based treatment algorithm for LG-NELM. METHODS: A treatment algorithm to maximize overall survival (OS) was designed using peer-reviewed articles evaluating treatment of LG-NELM. This algorithm was retrospectively applied to patients treated for LG-NELM at our institution. Deviation was determined based on whether or not a patient received treatment consistent with that recommended by the algorithm. Patients who did and did not deviate from the algorithm were compared with respect to OS and number of treatments. RESULTS: Applying our algorithm to a 149-patient cohort, 57 (38%) deviated from recommended treatment. Deviation occurred in the form of alternative (28, 49%) versus additional procedures (29, 51%). Algorithm deviators underwent significantly more procedures than non-deviators (median 1 vs. 2, p < 0.001). Cox model indicated no difference in OS associated with algorithm deviation (HR 1.19, p = 0.58) when controlling for age and tumor characteristics. CONCLUSION: This literature-based algorithm helps standardize treatment protocols in patients with LG-NELM and can reduce cost and risk by minimizing unnecessary procedures. Prospective implementation and validation is required.


Assuntos
Neoplasias Hepáticas , Tumores Neuroendócrinos , Algoritmos , Hepatectomia , Humanos , Neoplasias Hepáticas/cirurgia , Tumores Neuroendócrinos/cirurgia , Estudos Prospectivos , Estudos Retrospectivos , Taxa de Sobrevida
17.
Ann Surg Oncol ; 27(11): 4348-4359, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32681477

RESUMO

BACKGROUND: Previously published work has demonstrated that combining gemcitabine with irreversible electroporation (IRE) results in increased drug delivery to pancreatic adenocarcinoma cells in vivo. This study assessed the efficacy of IRE + gemcitabine and IRE + FOLFIRINOX (5-fluorouracil, leucovorin, irinotecan, and oxaliplatin), the impact of the superior regimen on survival, and the safety of electrochemotherapy in human subjects. METHODS: Histologic analysis was performed after in vitro and in vivo treatment of S2013 and Panc-1 pancreatic cancer cells and S2013 orthotopic tumors, respectively, and levels of apoptotic machinery and cell cycle proteins were evaluated using quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) and Western blot. RESULTS: Electrochemotherapy (ECT) with IRE and FOLFIRINOX resulted in increased tumor cells apoptosis compared with gemcitabine, gemcitabine + IRE, and FOLFIRINOX alone, and significantly improved overall survival when compared with mice treated with IRE or FOLFIRINOX. Increased tumor cell apoptosis, caspase-3 mRNA, active caspase-3 protein, and decreased cell proliferation were noted at the time of death or euthanasia in the ECT group compared with folinic acid alone. In five patients, ECT with either FOLFIRINOX or gemcitabine was well-tolerated and resulted in no dose-limiting toxicities. CONCLUSIONS: ECT thus results in synergistic antitumor activity compared with either treatment modality used alone, resulting in increased tumor cell apoptosis as well as decreased tumor cell proliferation and improved overall survival. Pilot data suggest that ECT represents a promising modality for the treatment of patients with locally advanced pancreatic cancer. TRIAL REGISTRATION: The human subject portion of this work was conducted as part of an investigator-initiated clinical trial at the University of Louisville (NCT03484299).


Assuntos
Adenocarcinoma , Protocolos de Quimioterapia Combinada Antineoplásica , Eletroquimioterapia , Neoplasias Pancreáticas , Adenocarcinoma/tratamento farmacológico , Animais , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Linhagem Celular Tumoral , Desoxicitidina/administração & dosagem , Desoxicitidina/análogos & derivados , Modelos Animais de Doenças , Fluoruracila/administração & dosagem , Humanos , Irinotecano/administração & dosagem , Leucovorina/administração & dosagem , Camundongos , Oxaliplatina/administração & dosagem , Neoplasias Pancreáticas/tratamento farmacológico , Resultado do Tratamento , Gencitabina
18.
J Surg Res ; 256: 206-211, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-32711177

RESUMO

BACKGROUND: Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) is a common treatment for peritoneal surface malignancies but no standard carrier solution currently exists for the procedure. This study compared a standard low-dextrose perfusate to a higher-dextrose dialysate that has previously shown favorable impact on perioperative patient outcomes in trauma settings. MATERIALS AND METHODS: A single-center retrospective study identified patients undergoing CRS/HIPEC from 2008 to 2019 with recorded dextrose concentration of administered perfusate. An institutional shift to a higher-dextrose solution was made in late 2015. Comparisons of preoperative factors, intraoperative and postoperative glucose levels, and postoperative outcomes were made using the chi-square test, Fisher's exact test, Wilcoxon rank sum test, or repeated measures analysis of variance. RESULTS: There were 97 patients in the study, 73 (75%) in the low-dextrose group and 24 (25%) in the high-dextrose group. There was no significant difference in peak intraoperative blood glucose levels between the 1.5% (mean 230 mg/dL) and the 2.5% group (mean 199 mg/dL, P = 0.15). Daily postoperative glucose values were also not statistically different (repeated measures analysis of variance, P = 0.18). Median length of stay was slightly lower for the high-dextrose group (10 d, interquartile range 8-15) than that for the low-dextrose group (12 d, interquartile range 9-17), but was not statistically significant (P = 0.29). Return of bowel function and resumption of diet were similar between the groups. The high-dextrose group had a lower rate of overall complications (20.8%) than the low-dextrose group (49.3%, P = 0.0143). Ninety-day mortality was equivalent between the two groups (2.7% low-dextrose, 4.2% high-dextrose, P = 1.0). CONCLUSIONS: Use of 2.5% dextrose-containing perfusate appears safe for CRS/HIPEC operations, does not negatively impact intraoperative or postoperative glucose levels, and may be associated with a decreased risk of complications.


Assuntos
Quimioterapia do Câncer por Perfusão Regional/efeitos adversos , Procedimentos Cirúrgicos de Citorredução/efeitos adversos , Glucose/efeitos adversos , Quimioterapia Intraperitoneal Hipertérmica/efeitos adversos , Neoplasias Peritoneais/terapia , Complicações Pós-Operatórias/epidemiologia , Antineoplásicos/administração & dosagem , Glicemia/análise , Quimioterapia do Câncer por Perfusão Regional/métodos , Soluções para Diálise/efeitos adversos , Soluções para Diálise/química , Feminino , Humanos , Quimioterapia Intraperitoneal Hipertérmica/métodos , Masculino , Pessoa de Meia-Idade , Neoplasias Peritoneais/mortalidade , Complicações Pós-Operatórias/sangue , Complicações Pós-Operatórias/etiologia , Estudos Prospectivos , Estudos Retrospectivos , Resultado do Tratamento
19.
J Surg Oncol ; 122(3): 407-411, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32483842

RESUMO

BACKGROUND AND OBJECTIVES: Irreversible electroporation (IRE) is a nonthermal electrical tumor ablative strategy for unresectable tumors. IRE is relatively safe around critical structures but may induce cardiac arrhythmia when its delivery is not synchronized to the cardiac cycle. We performed a systematic literature review to determine rates of arrhythmia when IRE was utilized with or without cardiac synchronization. METHODS: An online literature search was conducted with additional hand selection of articles. Data were extracted and pooled analyses were performed. RESULTS: Twelve articles were included in analysis. IRE was performed for 481 patients; 46% hepatic tumors (n = 223), 36% pancreatic lesions (n = 168), and multiple other locations including prostate. Synchronization was performed on 422 patients. Arrhythmias were noted in 3.7% of cases (n = 18/481); cardiac synchronization: 1.2% (n = 5/422) vs unsynchronized: 22.0% (n = 13/59), P < .0001. These events occurred in every organ except the prostate. CONCLUSIONS: IRE remains a potent technology for unresectable tumors, but arrhythmia is a clinical concern. This literature review confirms that cardiac gating should be used in all cases outside of prostate to prevent this potentially serious adverse event.


Assuntos
Técnicas de Ablação/estatística & dados numéricos , Arritmias Cardíacas/epidemiologia , Eletroporação/estatística & dados numéricos , Neoplasias Hepáticas/cirurgia , Neoplasias Pancreáticas/cirurgia , Técnicas de Ablação/efeitos adversos , Arritmias Cardíacas/diagnóstico por imagem , Arritmias Cardíacas/etiologia , Técnicas de Imagem de Sincronização Cardíaca/métodos , Humanos
20.
J Surg Oncol ; 122(3): 480-486, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32506498

RESUMO

INTRODUCTION: Surgical site infections (SSIs) lead to increased morbidity and cost. Negative-pressure wound therapy (NPWT) removes wound exudate and improves local blood flow, but its effect on SSI is unproven following hepatectomy and pancreatectomy. The aim of this trial was to evaluate the effect of NPWT on SSI in this population. METHODS: Patients were randomized to incisional NPWT or sterile island dressing following surgery. SSI predictive factors were recorded as well as patient comorbidities. Wound complications and type of SSI were recorded prospectively. RESULTS: Forty patients received the standardized perioperative bundle. Twenty patients received sterile island: 11 hepatic and 9 pancreatic resections; 20 patients received NPWT: 11 hepatic and 9 pancreatic resections; 23 patients were male; mean age 60.8 years (SD ±10.3); mean BMI 31.7 (SD ±7.0). There were three incisional wound infections: two with sterile island, one with NPWT; six organ space infections: four sterile island and two NPWT. There were no significant differences in SSI rates between groups (P = .57). CONCLUSION: NPWT does not improve SSI rates over simple sterile dressing following hepatectomy or pancreatectomy. Improvements in SSI must be directed toward organ-space infections, which are unaffected by NPWT.


Assuntos
Hepatectomia/métodos , Tratamento de Ferimentos com Pressão Negativa/métodos , Pancreatectomia/métodos , Infecção da Ferida Cirúrgica/prevenção & controle , Idoso , Bandagens , Feminino , Hepatectomia/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Pancreatectomia/efeitos adversos , Estudos Prospectivos , Infecção da Ferida Cirúrgica/etiologia , Resultado do Tratamento
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