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1.
Eur J Surg Oncol ; 49(9): 106978, 2023 09.
Article in English | MEDLINE | ID: mdl-37460370

ABSTRACT

INTRODUCTION: Neutral argon plasma (NAP) system could meet the requirements to achieve oncological cytoreduction of peritoneal carcinomatosis with miliary lesions, minimizing the associated morbidity. This phase I/II trial aims to establish the desirable dose that is safe and effective in eliminating tumor cells with lower penetration. METHODS: Patients diagnosed with different origins for peritoneal carcinomatosis and miliary implants were selected for the study. The safe and potentially effective dose (desirability) of NAP was evaluated according to three factors: distance (mm), application time (s) and power (%), to evaluate the response variables such as the presence of tumor cells (Y/N) and the depth of penetration. RESULTS: Ten patients and 120 samples were evaluated and treated with NAP. There was no vascular or organ injury intraoperative using a pre-established dose of 100% (coagulation mode) at a distance of 2-3 cm. The distance was found to be correlated with the presence of the tumor cells in ex-vivo analysis, with an OR of 15.4 (4.0-111.4). The time and energy used were protective factors to eliminate tumor cells with an OR of 0.4 (0.1-0.9) and 0.8 (0.8-0.9), respectively. The safest and most effective desirability results were as follows i) energy 80% during 2-4 s with a distance of 2 cm (0.89), and ii) energy 100% during 2-4 s with a distance of 3 cm (0.90). CONCLUSIONS: The use of NAP during a CRS and HIPEC is safe and effective for eradicating tumor cells on the peritoneal surface at suggested doses of energy, distance and duration. TRIAL IDENTIFICATION: ClinicalTrials.gov Identifier: NCT04904042.


Subject(s)
Hyperthermia, Induced , Peritoneal Neoplasms , Plasma Gases , Humans , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Combined Modality Therapy , Cytoreduction Surgical Procedures , Peritoneal Neoplasms/surgery , Survival Rate
2.
Cir. Esp. (Ed. impr.) ; 100(8)ago. 2022. ilus, tab
Article in Spanish | IBECS | ID: ibc-207748

ABSTRACT

Introducción Los tumores primarios de vena cava inferior son tumores raros de origen mesenquimal que surgen de la musculatura lisa de la pared. Debido a su escasa prevalencia, existen pocos datos definitivos sobre su tratamiento y pronóstico. Su tratamiento se basa en principios oncológicos generales. Métodos Se ha analizado una serie de 6 casos intervenidos desde 2010 a 2020, evaluando distintos parámetros relacionados con las características demográficas del tumor, del tratamiento recibido y de los resultados obtenidos en supervivencia y morbilidad. Además, se ha llevado a cabo una revisión bibliográfica de la evidencia disponible actualmente. Resultados En todos los pacientes se llevó a cabo una resección quirúrgica óptima con R0 en 4/6 y R1 en 2/6. La mayor morbilidad sucedió en un paciente fallecido en periodo intraoperatorio. Se realizó cavorrafia en un paciente y cavoplastia en 5/6 utilizando injerto criopreservado en 3/6 y prótesis en 2/6. Al final del seguimiento de nuestra serie (con una media de seguimiento de 10,7 meses), el 50% de los pacientes continúan vivos. La media de supervivencia fue de 11,3±9,07 meses. De los 6 pacientes, 3 presentaron recidivas hematógenas con un intervalo libre de enfermedad de 9±2 meses. Conclusión El diagnóstico y tratamiento del leiomiosarcoma de vena cava inferior continúa siendo un reto. Debido a su baja prevalencia, resultará difícil establecer un tratamiento totalmente estandarizado, y se recomienda su abordaje en centros especializados. Por otra parte, se deberían intentar aunar los casos intervenidos de cara a avanzar en el conocimiento del abordaje de esta enfermedad (AU)


Introduction Primary tumors of the inferior vena cava are rare tumors of mesenchymal origin. They arise from the smooth muscles of the vena cava wall. Due to its low prevalence, there are few definitive data on its treatment and prognosis. Its treatment is based on general oncological principles. Methods A series of six cases operated from 2010 to 2020 were analyzed. Different parameters related to the demographic characteristics, the tumor, the treatment received, and the results obtained in survival and morbidity were analyzed. In addition, a bibliographical review of the currently available evidence was carried out. Results Optimal surgical resection was accomplished in all patients with R0 in 4/6 and R1 in 2/6. The greatest morbidity occurred in a patient who died in the intraoperative period. Cavography was performed in one patient and cavoplasty in 5/6 using cryopreserved graft in 3/6 and prothesis in 2/6. The 50% were still alive at the end of the follow-up (with a mean follow-up of 10.7 months). The mean survival was 11.3±9.07 months. 3/6 patients presented hematogenous recurrences with a disease-free interval of 9±2 months. Conclusion The diagnosis and treatment of inferior vena cava leiomyosarcoma is still a challenge. Due to its low prevalence, it will be difficult to establish a totally standardized treatment and its approach is recommended in specialized centers. On the other hand, a multicentric study should be made to collect the most cases as possible in order to advance in the understanding of the approach to this disease (AU)


Subject(s)
Humans , Male , Female , Adult , Middle Aged , Aged , Leiomyosarcoma/surgery , Vascular Neoplasms/surgery , Vena Cava, Inferior , Retrospective Studies , Survival Analysis , Prognosis
3.
Eur J Surg Oncol ; 47(6): 1420-1426, 2021 06.
Article in English | MEDLINE | ID: mdl-33298341

ABSTRACT

INTRODUCTION: A laparoscopic approach for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (L-CRS+HIPEC) in highly selected patients has been reported in small cohorts with a demonstrable reduction in length of stay and post-operative morbidity. This study aims to analyse individual patient data from these international centres collected through the Peritoneal Surface Oncology Group International (PSOGI) L-CRS+HIPEC registry. METHODS: An international registry was designed through a networking database (REDCAP®). All centres performing L-CRS+HIPEC were invited through PSOGI to submit data on their cases. Patient's characteristics, postoperative outcomes and survival were analysed. RESULTS: Ten international centres contributed a total of 143 L-CRS+HIPEC patients during the study period. The most frequent indication was low grade pseudomyxoma peritonei in 79/143 (55%). Other indications were benign multicyst mesothelioma in 21/143(14%) and peritoneal metastasis from colon carcinoma in 18/143 (12,5%) and ovarian carcinoma in 13/143 (9%). The median PCI was 3 (2-5). The median length of stay was 6 (5-10) days, with 30-day major morbidity rate of 8.3% and 30-day mortality rate of 0.7%. At a median follow-up of 37 (16-64) months 126/143 patients (88.2%) were free of disease. CONCLUSIONS: Analysis of these data demonstrates that L-CRS+HIPEC is a safe and feasible procedure in highly selected patients with limited peritoneal disease when performed at experienced centres. While short to midterm outcomes are encouraging in patients with less invasive histology, longer follow up is required before recommending it for patients with more aggressive cancers with peritoneal dissemination.


Subject(s)
Colonic Neoplasms/pathology , Cytoreduction Surgical Procedures , Hyperthermic Intraperitoneal Chemotherapy , Mesothelioma/therapy , Ovarian Neoplasms/pathology , Peritoneal Neoplasms/pathology , Peritoneal Neoplasms/therapy , Pseudomyxoma Peritonei/therapy , Adult , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carboplatin/administration & dosage , Cisplatin/administration & dosage , Cytoreduction Surgical Procedures/adverse effects , Cytoreduction Surgical Procedures/methods , Disease-Free Survival , Doxorubicin/administration & dosage , Female , Follow-Up Studies , Humans , Hyperthermic Intraperitoneal Chemotherapy/methods , Laparoscopy/adverse effects , Length of Stay , Male , Mesothelioma/pathology , Middle Aged , Mitomycin/administration & dosage , Neoadjuvant Therapy , Neoplasm, Residual , Oxaliplatin/administration & dosage , Paclitaxel/administration & dosage , Peritoneal Neoplasms/secondary , Pseudomyxoma Peritonei/pathology , Registries , Severity of Illness Index , Survival Rate , Tumor Burden
4.
Tech Coloproctol ; 24(10): 1083-1088, 2020 10.
Article in English | MEDLINE | ID: mdl-32725353

ABSTRACT

BACKGROUND: The aim of our study was to present the technique for, and early results of complete laparoscopic pelvic peritonectomy (LPP) plus hyperthermic intraperitoneal chemotherapy (HIPEC). METHODS: We conducted a study on consecutive patients who had LPP for limited peritoneal carcinomatosis (peritoneal carcinomatosis index < 10) from ovarian cancer, colon cancer and benign multicystic mesothelioma, from January 2017 to November 2019 at 2 referral centers in Spain. Perioperative, pathologic, 30-day major morbidity and mortality characteristics were analyzed. The surgical technique is shown in the attached video. RESULTS: Twelve LPP + HIPEC were performed. Complete cytoreduction was achieved in 100% of the patients, the median duration of the operation was 450 min (range 360-600 min). There were 2 cases (16%) of IIIa morbidity (trocar hernia and pleural effusion), and no mortality. The median length of hospital stay was 5.5 days (range 4-10 days). The median length of follow-up was 10 months (range 2-30 months). There was a recurrence at the splenic hilum in 1 patient which was treated by laparoscopic splenectomy and one nodal recurrence at 13 months while all other patients are alive and free of disease at last follow-up. CONCLUSIONS: This is the first technical video of a minimally invasive approach for complete pelvic peritonectomy plus omentectomy associated with HIPEC. For highly selected patients, this procedure presents a feasible and safe alternative to the maximally invasive approach.


Subject(s)
Hyperthermia, Induced , Laparoscopy , Antineoplastic Combined Chemotherapy Protocols , Combined Modality Therapy , Female , Humans , Hyperthermic Intraperitoneal Chemotherapy , Neoplasm Recurrence, Local , Spain
5.
Ann Surg Oncol ; 26(8): 2595-2604, 2019 Aug.
Article in English | MEDLINE | ID: mdl-31111351

ABSTRACT

BACKGROUND: Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) are currently the most accepted treatment for peritoneal metastases from colorectal cancer. Restrictive selection criteria are essential to obtain the best survival benefits for this complex procedure. The most widespread score for patient selection, the peritoneal surface disease severity score (PSDSS), does not include current biological factors that are known to influence on prognosis. We investigated the impact of including RAS mutational status in the selection criteria for these patients. METHODS: We studied the risk factors for survival by multivariate analysis using a prospective database of consecutive patients with carcinomatosis from colorectal origin treated by CRS and HIPEC in our unit from 2009 to 2017. The risk factors obtained were validated in a multicentre, international cohort, including a total of 520 patients from 15 different reference units. RESULTS: A total of 77 patients were selected for local análisis. Only RAS mutational status (HR: 2.024; p = 0.045) and PSDSS stage (HR: 2.90; p = 0.009) were shown to be independent factors for overall survival. Early PSDSS stages I and II associated to RAS mutations impaired their overall survival with no significant differences with PSDSS stage III overall survival (p > 0.05). These results were supported by the international multicentre validation. CONCLUSIONS: By including RAS mutational status, we propose an updated RAS-PSDSS score that outperforms PSDSS alone providing a quick and feasible preoperative assessment of the expected overall survival for patients with carcinomatosis from colorectal origin undergone to CRS + HIPEC.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Chemotherapy, Cancer, Regional Perfusion/mortality , Colorectal Neoplasms/mortality , Cytoreduction Surgical Procedures/mortality , Hyperthermia, Induced/mortality , Mutation , Peritoneal Neoplasms/mortality , ras Proteins/genetics , Colorectal Neoplasms/genetics , Colorectal Neoplasms/pathology , Colorectal Neoplasms/therapy , Combined Modality Therapy , Female , Follow-Up Studies , Humans , Male , Middle Aged , Peritoneal Neoplasms/genetics , Peritoneal Neoplasms/secondary , Peritoneal Neoplasms/therapy , Prognosis , Retrospective Studies , Survival Rate
6.
Transplant Proc ; 51(1): 56-57, 2019.
Article in English | MEDLINE | ID: mdl-30736978

ABSTRACT

Herein we report on laparoscopic donor hepatectomy (left lateral sectionectomy) for pediatric living donor liver transplantation by using a pure laparoscopic approach. Seven laparoscopic living donor procedures were performed during the period March 2016 to February 2017 at our institution. The average age of donors was 33.3 years. Preoperative liver function was normal in all donors. Four donors required 1 or more Pringle maneuver(s). The etiology was biliary atresia (n = 3), metabolic disorders (n = 2) (OTC deficiency), Alagille syndrome (n = 1), and neonatal ductopenia (n = 1). The graft was implanted orthotopically in 6 patients; we performed an auxilliary transplantation in a patient with an OTC deficiency. The time of donor surgery was 363 minutes. Dindo-Clavien complications among donors were type I (n = 1), type IIa (n = 1), and type IIb (n = 2). The mean hospital stay for the recipients was 14 days. The mean donor stay was 3.7 days. Perioperative donor and recipient mortality was 0%. Graft survival was 87.5% with 1 graft loss secondary to inadequate venous outflow. In conclusion, we can propose the laparoscopic approach in experienced centers as a "standard of practice" due to its minimal complication rate and short hospital stay.


Subject(s)
Hepatectomy/methods , Laparoscopy/methods , Liver Transplantation/methods , Living Donors , Tissue and Organ Harvesting/methods , Adult , Child , Female , Graft Survival , Humans , Male , Spain
7.
Transplant Proc ; 51(1): 20-24, 2019.
Article in English | MEDLINE | ID: mdl-30655130

ABSTRACT

BACKGROUND: Ex vivo machine perfusion (MP) has been reported as a possibly method to rescue discarded organs. The main aim of this study was to report an initial experience in Spain using MP for the rescue of severely marginal discarded liver grafts, and to, secondarily, define markers of viability to test the potential applicability of these devices for the real increase in the organ donor pool. METHODS: The study began in January 2016. Discarded grafts were included in a research protocol that consisted of standard retrieval followed by 10 hours of cold ischemia. Next, either normothermic (NMP) or controlled subnormothermic (subNMP) rewarming was chosen randomly. Continuous measurements of portal-arterial pressure and resistance were screened. Lactate, pH, and bicarbonate were measured every 30 minutes. The perfusion period was 6 hours, after which the graft was discarded and evaluated as potentially usable, but never implanted. Biopsies of the donor and at 2, 4, and 6 hours after ex vivo MP were obtained. RESULTS: A total of 4 grafts were included in the protocol. The first 2 grafts were perfused by NMP and grafts 3 and 4 by subNMP. The second and third grafts showed a clear trend toward optimal recovery and may have been used. Lactate dropped to levels below 2.5 mmol/L with stable arterial and portal pressure and resistance. Clear biliary output started during MP. Biopsies showed an improvement of liver architecture with reduced inflammation at the end of the perfusion. CONCLUSION: This preliminary experience has demonstrated the potential of MP devices for the rescue of severely marginal liver grafts. Lactate and biliary output were useful for viability testing of the grafts. The utility of NMP or subNMP protocols requires further research.


Subject(s)
Liver Transplantation/methods , Organ Preservation/methods , Perfusion/methods , Tissue Donors/supply & distribution , Transplants , Cold Ischemia/methods , Extracorporeal Circulation/methods , Humans , Rewarming/methods , Spain , Transplants/pathology
8.
Transplant Proc ; 51(1): 25-27, 2019.
Article in English | MEDLINE | ID: mdl-30655137

ABSTRACT

In recent years, donation after circulatory death (DCD) has increased as an option to overcome the organ donor shortage crisis and to decrease the large number of patients on liver transplant waiting lists. The "super-rapid" technique is now the "gold standard" procurement method because of its availability, reproducibility, low cost, and extensive experience. Recently, extracorporeal support has been implemented, with encouraging results. Strict donor acceptance criteria have proven to be essential to optimize the DCD liver graft outcomes and minimize biliary complication rates. In this study we assessed the state of the art of DCD liver transplantation with regard to its development and the actual strategies to prevent graft complications, with aim of expanding the pool of marginal liver donors.


Subject(s)
Liver Transplantation/methods , Tissue Donors/supply & distribution , Tissue and Organ Procurement/methods , Adult , Death , Female , Graft Survival , Humans , Male , Middle Aged
9.
World J Surg ; 42(10): 3120-3124, 2018 10.
Article in English | MEDLINE | ID: mdl-29691625

ABSTRACT

BACKGROUND: The cytoreductive surgery (CRS) associated with hyperthermic intraperitoneal chemotherapy (HIPEC) has become the standard treatment in patients with carcinomatosis peritoneal from different origins. The use of a minimally invasive approach for this high complex procedure might be an alternative that provides them less morbidity and faster recovery with similar oncologic outcomes. METHODS: We describe the initial experience of CRS and HIPEC done via the laparoscopic route in patients with minimal peritoneal metastases in our Unit from March 2016 to January 2018. RESULTS: A total of eight patients were operated by this minimally invasive approach. The different diagnoses were low-grade pseudomyxoma peritonei (2), benign multicystic mesothelioma (2), primary epithelial ovarian carcinomatosis (2) and locally advanced colon carcinoma T4 (2). The median age was 54 (20-62) years, the median PCI was 3 (2-4), the median operative time was 287 min (240-360), complete cytoreduction CC0 was achieved in all the patients, and no major morbidity was observed. The median length of stay was 4.75 days (4-5). After a median follow-up of 9.5 months, no relapse has been observed. CONCLUSION: The results suggest that this minimally invasive approach for CRS and HIPEC is feasible and safe in a highly selected group of patients with peritoneal surface malignancies.


Subject(s)
Cytoreduction Surgical Procedures , Hyperthermia, Induced , Peritoneal Neoplasms/surgery , Pseudomyxoma Peritonei/drug therapy , Adult , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carcinoma/surgery , Colonic Neoplasms/drug therapy , Colonic Neoplasms/surgery , Female , Humans , Laparoscopy , Male , Mesothelioma/drug therapy , Mesothelioma/surgery , Middle Aged , Neoplasm Recurrence, Local/surgery , Ovarian Neoplasms/drug therapy , Ovarian Neoplasms/surgery , Percutaneous Coronary Intervention , Peritoneal Neoplasms/secondary , Peritoneum , Prospective Studies , Pseudomyxoma Peritonei/surgery , Retrospective Studies , Young Adult
10.
Transplant Proc ; 50(2): 664-668, 2018 Mar.
Article in English | MEDLINE | ID: mdl-29579883

ABSTRACT

INTRODUCTION: Some factors affect the pancreas of a marginal donor, and although their influence on graft survival has been determined, there is an increasing consensus to accept marginal organs in a controlled manner to increase the pool of organs. Certain factors related to the recipient have also been proposed as having negative influence on graft prognosis. The objective of this study was to analyze the influence of these factors on the results of our simultaneous pancreas-kidney (SPK) transplantation series. MATERIALS AND METHODS: Retrospective analysis of 126 SPK transplants. Donors and recipients were stratified in an optimal group (<2 expanded donor criteria) and a risk group (≥2 criteria). A pancreatic graft survival analysis was performed using a Kaplan-Meier test and log-rank test. Prognostic variables on graft survival were studied by Cox regression. Postoperative complications (graded by Clavien classification) were compared by χ2 test or Fisher test. RESULTS: Median survival of pancreas was 66 months, with no significant difference between groups (P > .05). Multivariate analysis showed risk factors to be donor age, cold ischemia time, donor body mass index, receipt body mass index, and receipt panel-reactive antibody. CONCLUSIONS: In our series, the use of pancreatic grafts from donors with expanded criteria is safe and has increased the pool of grafts. Different variables, both donor and recipient, influence the survival of the pancreatic graft and should be taken into account in organ distribution systems.


Subject(s)
Graft Survival , Kidney Transplantation/methods , Pancreas Transplantation/adverse effects , Postoperative Complications/epidemiology , Tissue Donors , Adult , Female , Humans , Kaplan-Meier Estimate , Kidney Transplantation/adverse effects , Male , Middle Aged , Multivariate Analysis , Pancreas Transplantation/methods , Postoperative Complications/etiology , Retrospective Studies , Risk Factors , Survival Analysis
11.
Transplant Proc ; 50(2): 673-675, 2018 Mar.
Article in English | MEDLINE | ID: mdl-29579885

ABSTRACT

INTRODUCTION: The use of intraoperative sodium heparin during simultaneous pancreas-kidney transplantation (SPKT) remains as a routine practice in some referral centers to minimize pancreatic graft thrombosis rate. One of its disadvantages is the theoretical increased risk of postoperative bleeding. In our center, we have abandoned its use since 2011. MATERIALS AND METHODS: We performed a retrospective analysis among 198 SPKTs performed in our center between the years 1989 and 2017. The variables of our study were vascular thrombosis of the pancreatic graft and hemoperitoneum and upper gastrointestinal bleeding in the mediate postoperative period (up to 2 months after the transplant). We compared these results between SPKT recipients who had undergone intraoperative heparinization (n = 157) and those who had not (n = 51). To avoid bias, a second comparison was performed using propensity score matching on the following characteristics: sex, recipient age, recipient body mass index, cold ischemia time, preoperative hemodialysis or peritoneal dialysis, time of diabetes, and Pancreas Donor Risk Index. Student t test or Mann-Whitney U test was used for intergroup comparisons of quantitative variables where appropriate, whereas χ2 or Fisher exact test was used to compare categorical data. RESULTS: No statistically significant differences were found when comparing the use of intraoperative heparin, even after the homogenization of both groups. CONCLUSIONS: In our experience, intraoperative heparinization during SPKT surgery was not useful because it did not significantly decrease the graft thrombosis rate, and its withdrawal did not enhance hemoperitoneum or upper gastrointestinal bleeding postoperative rates.


Subject(s)
Anticoagulants/therapeutic use , Heparin/therapeutic use , Kidney Transplantation/methods , Pancreas Transplantation/methods , Postoperative Hemorrhage/chemically induced , Thrombosis/prevention & control , Adult , Female , Graft Survival , Humans , Kidney Transplantation/adverse effects , Male , Middle Aged , Pancreas Transplantation/adverse effects , Postoperative Hemorrhage/epidemiology , Retrospective Studies , Thrombosis/etiology
12.
Transplant Proc ; 50(2): 676-678, 2018 Mar.
Article in English | MEDLINE | ID: mdl-29579886

ABSTRACT

INTRODUCTION: Solid organ donor hypernatremia has been classically reported to be a risk factor for cell lysis and graft damage. National criteria for pancreatic donation consider severe hypernatremia (sodium level more than 160 mEq/L) to be relative exclusion criteria. The aim of our study is to review the postoperative outcomes of our simultaneous pancreas-kidney transplantation (SPKT) sample in terms of pancreatic fistula, intra-abdominal abscesses, pancreatitis, pancreas graft thrombosis, early pancreatectomy, and reoperation rates regarding different ranges of donor sodium levels. MATERIAL AND METHODS: We performed a retrospective analysis among 161 SPKTs performed in our center between the years 2001 and 2017. We compared the aforementioned postoperative variables in two situations: 1) Whether the donor pancreas sodium levels were inferior to 149 mEq/L, or equal to or greater than 150 mEq/L; and 2) If they had severe hypernatremia (considering sodium levels greater than or equal to 160 mEq/L as threshold) or not. To ensure the comparability of the groups, a second comparison was performed on new samples after using propensity score matching. A Student t test or Mann-Whitney U test was used for intergroup comparisons of quantitative variables where appropriate, whereas a χ2 test or Fisher's exact test was used to compare categorical data. RESULTS: No statistically significant differences were found between the groups that relate high donor serum sodium levels with the morbidity variables included in our study or with early pancreatic graft loss. CONCLUSIONS: In our cohort, early postoperative main morbidity and pancreas graft loss of SPKT recipients do not differ significantly regarding donor serum sodium levels.


Subject(s)
Hypernatremia , Kidney Transplantation/methods , Pancreas Transplantation/methods , Postoperative Complications/etiology , Tissue Donors , Adult , Female , Humans , Male , Middle Aged , Postoperative Complications/epidemiology , Retrospective Studies , Risk Factors
13.
BMC Cancer ; 18(1): 183, 2018 02 13.
Article in English | MEDLINE | ID: mdl-29439668

ABSTRACT

BACKGROUND: Local relapse and peritoneal carcinomatosis (PC) for pT4 colon cancer is estimated in 15,6% and 36,7% for 12 months and 36 months from surgical resection respectively, achieving a 5 years overall survival of 6%. There are promising results using prophylactic HIPEC in this group of patients, and it is estimated that up to 26% of all T4 colon cancer could benefit from this treatment with a minimal morbidity. Adjuvant HIPEC is effective to avoid the possibility of peritoneal seeding after surgical resection. Taking into account these results and the cumulative experience in HIPEC use, we will lead a randomized controlled trial to determine the effectiveness and safety of adjuvant treatment with HIPEC vs. standard treatment in patients with colon cancer at high risk of peritoneal recurrence (pT4). METHODS/DESIGN: The aim of this study is to determine the effectiveness and safety of adjuvant HIPEC in preventing the development of PC in patients with colon cancer with a high risk of peritoneal recurrence (cT4). This study will be carried out in 15 Spanish HIPEC centres. Eligible for inclusion are patients who underwent curative resection for cT4NxM0 stage colon cancer. After resection of the primary tumour, 200 patients will be randomized to adjuvant HIPEC followed by routine adjuvant systemic chemotherapy in the experimental arm, or to systemic chemotherapy only in the control arm. Adjuvant HIPEC will be performed simultaneously after the primary resection. Mitomycin C will be used as chemotherapeutic agent, for 60 min at 42-43 °C. Primary endpoint is loco-regional control (LC) in months and the rate of loco-regional control (%LC) at 12 months and 36 months after resection. DISCUSSION: We assumed that adjuvant HIPEC will reduce the expected absolute risk of peritoneal recurrence from 36% to 18% at 36 months for T4 colon-rectal carcinoma. TRIAL REGISTRATION: NCT02614534 ( clinicaltrial.gov ) Nov-2015.


Subject(s)
Colorectal Neoplasms/surgery , Colorectal Neoplasms/therapy , Hyperthermia, Induced/methods , Mitomycin/therapeutic use , Adult , Aged , Antibiotics, Antineoplastic/therapeutic use , Combined Modality Therapy , Female , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Treatment Outcome , Young Adult
14.
Transplant Proc ; 48(9): 3037-3039, 2016 Nov.
Article in English | MEDLINE | ID: mdl-27932141

ABSTRACT

BACKGROUND: The Pancreatic Donor Risk Index (PDRI) was developed in 2010 in the United States to predict graft survival after pancreas transplantation, based on donor characteristics and logistical and technical conditions. The aim of the study was to validate the utility of PDRI as a pancreas allograft survival predictor in simultaneous pancreas-kidney transplantation (SPK) transplants performed in our hospital between 2000 and 2015. METHODS: This retrospective analysis of 126 SPK transplants was performed by the same surgical team from the years 2000 to 2015. Donor variables that are integrated in the PDRI were calculated (age, sex, race, creatinine serum levels, body mass index, height, cold ischemia time, cause of death, type of pancreas transplant). Pancreatic graft survival at 1 and 5 years was calculated by use of the Kaplan-Meier test. Comparison of survival curves between PDRI risk quartiles was calculated by use of the log-rank test. Association between graft survival and variables integrating the PDRI was calculated by use of univariate Cox regression analysis. RESULTS: Log-rank analysis found no statistically significant association between global graft survival and PDRI quartiles. Univariate Cox regression analysis showed a statistically significant association between graft survival and cold ischemia time (P < .05). CONCLUSIONS: PDRI was not a useful tool to predict pancreatic graft outcomes in a Spanish reference population.


Subject(s)
Kidney Transplantation/adverse effects , Pancreas Transplantation/adverse effects , Tissue Donors/statistics & numerical data , Adult , Female , Graft Survival/physiology , Hospitals/statistics & numerical data , Humans , Kaplan-Meier Estimate , Kidney Transplantation/methods , Kidney Transplantation/mortality , Male , Pancreas Transplantation/methods , Pancreas Transplantation/mortality , Regression Analysis , Retrospective Studies , Risk Assessment/methods , Risk Factors , United States , Young Adult
15.
Eur J Surg Oncol ; 42(6): 869-76, 2016 Jun.
Article in English | MEDLINE | ID: mdl-26898841

ABSTRACT

BACKGROUND: The acute renal dysfunction (ARD) is a common complication in cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC). Our aim is evaluate the ARD post-HIPEC procedures using the RIFLE and AKIN criteria. Evaluate the risk factors and analyze ARD's impact on postoperative course. METHODS: From 2011 to 2014, in a retrospective way using a prospective database were operated by HIPEC procedure. The ARD was analyzed by RIFLE and AKIN criteria. The perioperative features were analyzed and a multivariate analysis was performed to define the risk factors to develop the ARD. RESULTS: 141 patients were treated and analyzed. The ARD was detected in 30.5% (Injury 18.4% and Failure 12.1%) when RIFLE criteria were applied. The multivariate analysis detected that decrease of pH during HIPEC [OR = 29.39 (5.09-169.76)], PCI [OR = 1.07 (1.01-1.15)] and ureteral catheters [OR = 12.71 (1.44-111.85)] were associated to the development of acute renal injury (ARI) post-HIPEC. Decrease of Na during HIPEC [OR = 1.15 (1.01-1.30)], intraoperative inotrope use [OR = 3.83 (1.12-13.09)] and PCI [OR = 1.06 (1.0-1.14)] were associated to acute renal failure (ARF) post-HIPEC. The ARD was related to a higher length of stay hospital (17.2 ± 11 vs. 13.8 ± 8 days) (p = 0.05) but no impact in early survival was observed in ARD group. CONCLUSIONS: The widespread use of RIFLE criteria for ARD would have major benefits in terms of accurately diagnosing patients undergone HIPEC procedures. The ARD has a detrimental impact in length of stay hospital. The knowledge of risk factors helps us to prevent the ARD post-HIPEC by means of an aggressive and multidisciplinary perioperative management.


Subject(s)
Acute Kidney Injury/chemically induced , Acute Kidney Injury/diagnosis , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Chemotherapy, Cancer, Regional Perfusion/methods , Cytoreduction Surgical Procedures , Early Diagnosis , Hyperthermia, Induced/adverse effects , Ovarian Neoplasms/drug therapy , Peritoneal Neoplasms/drug therapy , Acute Kidney Injury/prevention & control , Adult , Aged , Chemotherapy, Cancer, Regional Perfusion/adverse effects , Female , Humans , Kaplan-Meier Estimate , Length of Stay , Male , Middle Aged , Ovarian Neoplasms/surgery , Patient Care Team , Peritoneal Neoplasms/surgery , Predictive Value of Tests , Retrospective Studies , Risk Assessment , Risk Factors , Treatment Outcome
16.
Eur J Surg Oncol ; 42(2): 224-33, 2016 Feb.
Article in English | MEDLINE | ID: mdl-26673283

ABSTRACT

BACKGROUND: Cytoreductive surgery with peritonectomy procedures and hyperthermic intraperitoneal chemotherapy (CRS + HIPEC) represents a radical therapeutic approach to achieve complete cytoreduction in ovarian peritoneal carcinomatosis. The aim of the present study was to analyze the outcomes obtained by the application of these procedures in a single center with extensive experience treating peritoneal carcinomatosis. PATIENTS AND METHODS: A series of 218 consecutive patients diagnosed with peritoneal carcinomatosis from primary or recurrent ovarian cancer (FIGO stage IIIC-IV) and treated with CRS + HIPEC between January 1996 and June 2012 were included in this observational study. RESULTS: Peritoneal carcinomatosis was treated primarily in 56% (124/218) of the cases and recurrently in 43% (94/218). A total of 42/218 patients (19%) presented with FIGO stage IV. Compared to recurrent cases, patients with primary ovarian carcinomatosis were older and presented higher Peritoneal Cancer Index (PCI) and percentage of FIGO stage IV; however, no significant differences in survival (5-year overall survival in patients with R0 cytoreduction, 63% and 56%, respectively) were observed. Cytoreduction score, PCI, lymphatic involvement and surgical morbidity ≥Grade III were statistically significant prognostic factors for survival in both univariate and multivariate analysis. CONCLUSIONS: CRS + HIPEC treating macroscopic and microscopic disease is currently an excellent surgical approach to achieve high rates of complete cytoreduction and improve survival in patients with peritoneal carcinomatosis from ovarian cancer. In order to minimize the high potential morbidity of these procedures, CRS + HIPEC should be performed in highly experienced centers.


Subject(s)
Carcinoma/therapy , Hyperthermia, Induced , Neoplasm Recurrence, Local/pathology , Ovarian Neoplasms/pathology , Peritoneal Neoplasms/therapy , Adult , Age Factors , Aged , Aged, 80 and over , Antineoplastic Agents/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carcinoma/mortality , Carcinoma/secondary , Cisplatin/administration & dosage , Cytoreduction Surgical Procedures , Female , Hospitals, High-Volume , Humans , Infusions, Parenteral , Middle Aged , Neoplasm Staging , Paclitaxel/administration & dosage , Peritoneal Neoplasms/mortality , Peritoneal Neoplasms/secondary , Survival Rate , Young Adult
17.
Transplant Proc ; 46(9): 3076-8, 2014 Nov.
Article in English | MEDLINE | ID: mdl-25420826

ABSTRACT

BACKGROUND: The use of expanded criteria for donors to expand the donor pool has increased the number of discarded liver grafts in situ. The aim of our study was to elaborate a prediction model to reduce the percentage of liver grafts discarded before the procuring team is sent out. METHODS: We analyzed the donor factors of 244 evaluated candidates for liver donation. We performed a multiple logistic regression to evaluate the probability of liver grafts discarded (PD). RESULTS: The PD was determined by use of 3 variables: age, pathological ultrasonography, and body mass index >30. The area under curve was 82.7%, and, for a PD of 70%, the false-positive probability was 1.2%. CONCLUSIONS: We have created a useful clinical prediction model that could avoid up to 20% of discarded liver grafts.


Subject(s)
Liver Transplantation , Tissue and Organ Procurement , Adult , Aged , Allografts , Female , Humans , Logistic Models , Male , Middle Aged , Multivariate Analysis , ROC Curve , Tissue Donors , Transplants
18.
Transplant Proc ; 41(6): 2444-6, 2009.
Article in English | MEDLINE | ID: mdl-19715946

ABSTRACT

OBJECTIVE: To analyze the primary factors that influence the development and consolidation of a pediatric liver transplantation program. PATIENTS AND METHODS: This was a retrospective study of 100 liver transplantation procedures performed in 84 pediatric patients between May 1990 and November 2007. The male-female ratio was 40:60. Mean (SD) age was 5 years (40 patients were younger than 2 years); cold ischemia time was 7.10 (3.1) hours; surgery time was 5.2 (2.2) hours; and time on the waiting list for transplantation was 75 (range, 1-1012) days. Indications for transplantation included cholestatic disease (43%), acute hepatic failure (AHF; 34%), metabolic disorders (14%), and cirrhosis (9%). Transplanted organs included 3 split grafts, 29 partial grafts, and 8 living-donor grafts. RESULTS: Mean graft survival was 70.4%, 59.2%, and 58.1% at 1, 3, and 5 years, respectively. Factors that influenced graft outcome were age younger than 2 years; surgery time more than 6 hours; and AHF vs cholestatic disease, metabolic disorders, and cirrhosis. There were no significant differences in long-term (51% vs 59%) and short-term (71% vs 70%) graft survival between procedures performed in 1990-1998 compared with those performed in 1999-2007; however, there was a higher percentage (P = .005) of recipients at high risk (age younger than 2 years or with AHF) in the later period. All data were consistent with those of the European Liver Transplant Registry 2007. CONCLUSIONS: A pediatric liver transplantation program can be established by a group experienced in liver transplantation.


Subject(s)
Liver Transplantation/methods , Child , Child, Preschool , Female , Graft Survival/physiology , Humans , Infant , Infant, Newborn , Liver Diseases/classification , Liver Diseases/surgery , Liver Transplantation/mortality , Liver Transplantation/physiology , Living Donors , Male , Retrospective Studies , Time Factors , Tissue and Organ Procurement/methods , Waiting Lists
19.
Transplant Proc ; 40(9): 2952-4, 2008 Nov.
Article in English | MEDLINE | ID: mdl-19010157

ABSTRACT

Postoperative Model for End-stage Liver Disease (MELD) values have never been assessed to predict very early (<1 week) death after liver transplantation (OLT). We retrospectively reviewed 275 consecutive OLTs performed in 252 recipients reported in a prospective database. We calculated the MELD score (pre-MELD) and consecutive postoperative MELD (post-MELD) scores computed daily during the first postoperative week and on days 15 and 30 after OLT. Post-MELD scores from nonsurviving recipients displayed on a scatterplot of immediate probability of death were adjusted to the best goodness-of-fit curve, and, finally, depicted graphically as a receiver operating characteristic (ROC) curve. Nonsurviving recipients showed higher post-MELD scores: day 1: 23.5 versus 16.6 (P = .05); day 3: 25.1 versus 12.5 (P = .000); day 5: 25.7 versus 11.8 (P = .000); and day 7: 22.1 versus 10.2 (P = .000). Overall comparisons were performed using a time-dependent general linear regression model, revealing higher post-MELD scores for nonsurviving recipients, irrespective of postoperative time (P = .002). The best goodness-of-fit curve was displayed when adjusting to a theoretical exponential regression curve calculated as follows: Probability of dying within the first week (%) = 3.36 x e(0.079 x (post-MELD)) (r = .89; P = .000). The area under the ROC curve was 0.783 (95% confidence interval, 0.630-0.935; P = .001). The model had a positive predictive value of 82.3%, a negative predictive value of 33.1%, and an accuracy of 79.2%. In conclusion, this study corroborated the suggestion that the MELD score may serve as a reliable tool to assess very early death after OLT.


Subject(s)
Liver Failure/classification , Liver Failure/surgery , Liver Transplantation/physiology , Adolescent , Adult , Aged , Confidence Intervals , Databases, Factual , Female , Humans , Liver Transplantation/mortality , Male , Middle Aged , Postoperative Period , Predictive Value of Tests , Preoperative Care , Probability , ROC Curve , Reoperation/statistics & numerical data , Retrospective Studies , Survival Rate , Survivors , Treatment Failure , Treatment Outcome , Young Adult
20.
Rev. esp. enferm. dig ; 99(12): 703-708, dic. 2007. ilus, tab
Article in Es | IBECS | ID: ibc-63314

ABSTRACT

Objetivo: analizar los posibles factores pronósticos de supervivenciaen tumores estromales gastrointestinales c-kit positivo(GIST), tras citorreducción óptima R0.Pacientes y método: estudio de 35 pacientes intervenidosen nuestra Unidad desde enero 2002 a febrero 2007, con tumoresdel estroma gastrointestinal CD117/c-kit positivo en los quese alcanzó citorreducción quirúrgica sin residuo tumoral macroscópico.Una base de datos prospectiva nos proporcionó las distintasvariables analizadas, de carácter demográfico, anatómico, clínico,histopatológico e inmunohistoquímico, entre otras. Elanálisis de la supervivencia actuarial se realizó según el método deKaplan-Meier y el análisis multivariante mediante el método de regresiónmúltiple de Cox.Resultados: la supervivencia global a 5 años fue del 77%,con una supervivencia media de 52 meses. El riesgo de malignidadsegún la clasificación de Fletcher y el tamaño tumoral mayorde 10 cm, influyeron significativamente de forma negativa sobrela supervivencia de los pacientes, tras el análisis univariante realizado(p < 0,05). La actividad proliferativa Ki-67 mayor del 50%fue la única covariable con significación estadística en el análisismultivariante. El 20% de los tumores recurrieron. Sólo 3 pacientesmetastáticos recibieron tratamiento adyuvante con mesilato deimatinib, todos ellos con Ki-67 > 50% y vivos en la actualidad.Conclusiones: el índice proliferativo Ki-67 podría representarun excelente marcador pronóstico de supervivencia en aquellospacientes con tumores del estroma gastrointestinal c-kit positivo.Su confirmación y el punto de corte adecuado deberían serobjeto de futuros estudios prospectivos, así como su posible utilidadpara seleccionar pacientes candidatos al tratamiento con mesilatode imatinib


Objective: to analyze the different factors predictive of survivalassociated with optimal R0-cytoreduction in c-kit-positivegastrointestinal stromal tumors.Methods: thirty-five patients were operated on in our OncologicalSurgery Department from January 2002 to February2007 because of CD117/c-kit-positive gastrointestinal stromal tumors,and an optimal surgical cytoreduction was obtained withoutmacroscopical residual disease. Demographic, anatomical, clinical,pathological, and immunohistochemical variables were analyzedfrom a specific database. Survival and multivariate analyseswere developed using Kaplan-Meier and multiple Cox regressionmodels, respectively.Results: five-year overall survival was 77% with a mean survivalof 52 months. Risk of malignant behaviour according toFletcher’s classification and tumor size higher than 10 cm had asignificantly negative influence on overall survival in the univariateanalysis (p < 0.05). Proliferative Ki-67 activity higher than 50%was the only statistically significant variable in the multivariateanalysis. Twenty percent of tumors recurred. Only 3 patients withmetastatic disease received adjuvant treatment with imatinib mesylate,all of them with Ki-67 > 50% and currently alive.Conclusions: the poliferative Ki-67 index could represent anexcellent predictive factor for survival in patients with c-kit-positivestromal gastrointestinal tumors. Confirmation and an adequatecut-off level should be the main objectives for futureprospective studies, mostly focused on the appropriate selectionof optimal candidates to imatinib-mesylate-based treatment


Subject(s)
Humans , Stromal Cells/pathology , Gastrointestinal Neoplasms/pathology , Prognosis , Regression Analysis , Proto-Oncogene Proteins c-kit/isolation & purification , Ki-67 Antigen/analysis , Survival Rate , Prospective Studies , Mesenchymoma/pathology
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