Treatment of Peritoneal Surface Malignancies by Cytoreductive Surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Spain: Results of the National Registry of the Spanish Group of Peritoneal Oncologic Surgery (REGECOP).

INTRODUCTION: Treatment of Peritoneal Surface Malignancies (PSM) with cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) has achieved results never seen before in these patients, which classically have a poor prognosis. The possibility of conducting clinical trials in these diseases is complicated, since some of them are rare, so the analysis of large databases provides very valuable scientific information. The aim of this study is to analyze the global results of the National Registry of the Spanish Group of Peritoneal Oncologic Surgery (REGECOP), whose objective is to register all patients scheduled for HIPEC nationwide. METHODS: This is a retrospective analysis of the data recorded in the REGECOP from 36 Spanish hospitals from 2001 to 2021. There were 4159 surgical interventions in 3980 patients. RESULTS: 66% are women and 34% are men with a median age of 59 years (range 17-86). 41.5% of the patients were treated for Peritoneal Metastases (PM) of colorectal cancer (CRC); 32.4% were women with ovarian cancer (OC) with PM; 12.8% were treated for pseudomyxoma peritonei (PMP); 6.2% had PM from gastric cancer (GC); 4.9% had PM of non-conventional origin; and, finally, 2.1% of cases were patients diagnosed with peritoneal mesothelioma. The median Peritoneal Cancer Index (PCI) was 9 (0-39), and complete cytoreduction was achieved in 81.7% of the procedures. Severe morbidity (Dindo-Clavien grade III-IV) was observed in 17.7% of surgeries, with 2.1% mortality. Median hospital stay was 11 days (0-259). Median overall survival (OS) was 41 months for CRC patients, 55 months for women with OC, was not reached in PMP patients, was 14 months for GC patients, and 66 months in mesothelioma patients. CONCLUSIONS: large databases provide extremely useful data. CRS with HIPEC in referral centers is a safe treatment with encouraging oncologic results in PSM.

Updated Review and Clinical Recommendations for the Diagnosis and Treatment of Patients with Retroperitoneal Sarcoma by the Spanish Sarcoma Research Group (GEIS).

Soft tissue sarcomas (STS) are an uncommon and biologically heterogeneous group of tumors arising from mesenchymal cells. The incidence is estimated at five cases per 100,000 people per year. Retroperitoneal sarcomas (RPS) account for 10-15% of all STS, and their management depends on their anatomical characteristics and histotype. Due to their very low incidence, it is recommended that RPS be treated in reference centers and evaluated by an experienced multidisciplinary team (MDT). In Spain, the Spanish Group for Research in Sarcomas (GEIS) brings together experts from various specialties to promote research on sarcomas and improve treatment results. This paper summarizes the GEIS recommendations for the diagnosis, treatment, and follow-up of patients with RPS.

The Role of Intraperitoneal Intraoperative Chemotherapy with Paclitaxel in the Surgical Treatment of Peritoneal Carcinomatosis from Ovarian Cancer-Hyperthermia versus Normothermia: A Randomized Controlled Trial.

BACKGROUND: The treatment of ovarian carcinomatosis with cytoreductive surgery and HIPEC is still controversial. The effect and pharmacokinetics of the chemotherapeutics used (especially taxanes) are currently under consideration. METHODS: A phase II, simple blind and randomized controlled trial (NTC02739698) was performed. The trial included 32 patients with primary or recurrent ovarian carcinomatosis undergoing cytoreductive surgery (CRS) and intraoperative intraperitoneal chemotherapy with paclitaxel (PTX): 16 in hyperthermic (42-43 °C) and 16 in normothermic (37 °C) conditions. Tissue, serum and plasma samples were taken in every patient before and after intraperitoneal chemotherapy to measure the concentration of PTX. To analyze the immunohistochemical profile of p53, p27, p21, ki67, PCNA and caspase-3 and the pathological response, a scale of intensity and percentage of expression and a grouped Miller and Payne system were used, respectively. Perioperative characteristics and morbi-mortality were also analyzed. RESULTS: The main characteristics of patients, surgical morbidity, hemotoxicity and nephrotoxicity were similar in both groups. The concentration of paclitaxel in the tissue was higher than that observed in plasma and serum, although no statistically significant differences were found between the two groups. No statistically significant association regarding pathological response and apoptosis (caspase-3) between both groups was proved. There were no statistically significant differences between the normothermic and the hyperthermic group for pathological response and apoptosis. CONCLUSIONS: The use of intraperitoneal PTX has proven adequate pharmacokinetics with reduction of cell cycle and proliferation markers globally without finding statistically significant differences between its administration under hyperthermia versus normothermia conditions.

GECOP-MMC: phase IV randomized clinical trial to evaluate the efficacy of hyperthermic intraperitoneal chemotherapy (HIPEC) with mytomicin-C after complete surgical cytoreduction in patients with colon cancer peritoneal metastases.

BACKGROUND: The French PRODIGE 7 trial, published on January 2021, has raised doubts about the specific survival benefit provided by HIPEC with oxaliplatin 460 mg/m2 (30 minutes) for the treatment of peritoneal metastases from colorectal cancer. However, several methodological flaws have been identified in PRODIGE 7, specially the HIPEC protocol or the choice of overall survival as the main endpoint, so its results have not been assumed as definitive, emphasizing the need for further research on HIPEC. It seems that the HIPEC protocol with high-dose mytomicin-C (35 mg/m2) is the preferred regime to evaluate in future clinical studies. METHODS: GECOP-MMC is a prospective, open-label, randomized, multicenter phase IV clinical trial that aims to evaluate the effectiveness of HIPEC with high-dose mytomicin-C in preventing the development of peritoneal recurrence in patients with limited peritoneal metastasis from colon cancer (not rectal), after complete surgical cytoreduction. This study will be performed in 31 Spanish HIPEC centres, starting in March 2022. Additional international recruiting centres are under consideration. Two hundred sixteen patients with PCI ≤ 20, in which complete cytoreduction (CCS 0) has been obtained, will be randomized intraoperatively to arm 1 (with HIPEC) or arm 2 (without HIPEC). We will stratified randomization by surgical PCI (1-10; 11-15; 16-20). Patients in both arms will be treated with personalized systemic chemotherapy. Primary endpoint is peritoneal recurrence-free survival at 3 years. An ancillary study will evaluate the correlation between surgical and pathological PCI, comparing their respective prognostic values. DISCUSSION: HIPEC with high-dose mytomicin-C, in patients with limited (PCI ≤ 20) and completely resected (CCS 0) peritoneal metastases, is assumed to reduce the expected risk of peritoneal recurrence from 50 to 30% at 3 years. TRIAL REGISTRATION: EudraCT number: 2019-004679-37; Clinicaltrials.gov: NCT05250648 (registration date 02/22/2022, ).

Erratum: Hindi, N., et al. Trabectedin Plus Radiotherapy for Advanced Soft-Tissue Sarcoma: Experience in Forty Patients Treated at a Sarcoma Reference Center. Cancers 2020, 12, 3740.

The authors noticed that content of "Conflicts of Interest" in the original version [...].

Executive summary of the Consensus Document of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) and of the Spanish Association of Surgeons (AEC) in antibiotic prophylaxis in surgery / Resumen ejecutivo del Documento de Consenso de la Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica (SEIMC) y de la Asociación Española de Cirujanos (AEC) en profilaxis antibiótica en cirugía

Antibiotic prophylaxis in surgery is one of the most effective measures for preventing surgical site infection, although its use is frequently inadequate and may even increase the risk of infection, toxicities and bacterial resistance. As a result of advances in surgical techniques and the emergence of multidrug-resistant organisms, the current guidelines for prophylaxis need to be revised. La Sociedad Española de Enfermedades Infecciosas (Spanish Society of Infectious Diseases and Clinical Microbiology) (SEIMC) together with the Asociación Española de Cirujanos (Spanish Association of Surgeons) (AEC) have revised and updated the recommendations for antibiotic prophylaxis to adapt them to any type of surgical intervention and to current epidemiology. This document gathers together the recommendations on antimicrobial prophylaxis in the various procedures, with doses, duration, prophylaxis in special patient groups, and in epidemiological settings of multidrug resistance to facilitate standardized management and the safe, effective and rational use of antibiotics in elective surgery

La profilaxis antibiótica en cirugía es una de las medidas más eficaces para la prevención de la infección de localización quirúrgica, aunque su uso es con frecuencia inadecuado, pudiendo incrementar el riesgo de infección, toxicidades y resistencias bacterianas. Debido al avance en las técnicas quirúrgicas y la emergencia de microorganismos multirresistentes, las actuales pautas de profilaxis precisan ser revisadas. La Sociedad Española de Enfermedades Infecciosas (SEIMC), conjuntamente con la Asociación Española de Cirujanos (AEC), ha revisado y actualizado las recomendaciones de profilaxis antimicrobiana para adaptarlas a cada tipo de intervención quirúrgica y a la epidemiología actual. En este documento se recogen las recomendaciones de los antimicrobianos utilizados en profilaxis en los diferentes procedimientos, las dosis, la duración, la profilaxis en huéspedes especiales, y en situación epidemiológica de multirresistencia, de tal forma que permitan un manejo estandarizado, un uso racional, seguro y efectivo de los mismos en la cirugía electiva

Resumen ejecutivo del Documento de Consenso de la Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica (SEIMC) y de la Asociación Española de Cirujanos (AEC) en profilaxis antibiótica en cirugía / Executive summary of the Consensus Document of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) and of the Spanish Association of Surgeons (AEC) in antibiotic prophylaxis in surgery

La profilaxis antibiótica en cirugía es una de las medidas más eficaces para la prevención de la infección de localización quirúrgica, aunque su uso es con frecuencia inadecuado, pudiendo incrementar el riesgo de infección, toxicidades y resistencias bacterianas. Debido al avance en las técnicas quirúrgicas y la emergencia de microorganismos multirresistentes las actuales pautas de profilaxis precisan ser revisadas. La Sociedad Española de Enfermedades Infecciosas (SEIMC), conjuntamente con la Asociación Española de Cirujanos (AEC) ha revisado y actualizado las recomendaciones de profilaxis antimicrobiana para adaptarlas a cada tipo de intervención quirúrgica y a la epidemiología actual. En este documento se recogen las recomendaciones de los antimicrobianos utilizados en profilaxis en los diferentes procedimientos, las dosis, la duración, la profilaxis en huéspedes especiales, y en situación epidemiológica de multirresistencia, de tal forma que permitan un manejo estandarizado, un uso racional, seguro y efectivo de los mismos en la cirugía electiva

Antibiotic prophylaxis in surgery is one of the most effective measures for preventing surgical site infection, although its use is frequently inadequate and may even increase the risk of infection, toxicities and antimicrobial resistance. As a result of advances in surgical techniques and the emergence of multidrug-resistant organisms, the current guidelines for prophylaxis need to be revised. The Sociedad Española de Enfermedades Infecciosas (Spanish Society of Infectious Diseases and Clinical Microbiology) (SEIMC) together with the Asociación Española de Cirujanos (Spanish Association of Surgeons) (AEC) have revised and updated the recommendations for antibiotic prophylaxis in surgery to adapt them to any type of surgical intervention and to current epidemiology. This document gathers together the recommendations on antimicrobial prophylaxis in the various procedures, with doses, duration, prophylaxis in special patient groups, and in epidemiological settings of multidrug resistance to facilitate standardized management and the safe, effective and rational use of antibiotics in elective surgery

Executive summary of the Consensus Document of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) and of the Spanish Association of Surgeons (AEC) in antibiotic prophylaxis in surgery.

Antibiotic prophylaxis in surgery is one of the most effective measures for preventing surgical site infection, although its use is frequently inadequate and may even increase the risk of infection, toxicities and bacterial resistance. As a result of advances in surgical techniques and the emergence of multidrug-resistant organisms, the current guidelines for prophylaxis need to be revised. La Sociedad Española de Enfermedades Infecciosas (Spanish Society of Infectious Diseases and Clinical Microbiology) (SEIMC) together with the Asociación Española de Cirujanos (Spanish Association of Surgeons) (AEC) have revised and updated the recommendations for antibiotic prophylaxis to adapt them to any type of surgical intervention and to current epidemiology. This document gathers together the recommendations on antimicrobial prophylaxis in the various procedures, with doses, duration, prophylaxis in special patient groups, and in epidemiological settings of multidrug resistance to facilitate standardized management and the safe, effective and rational use of antibiotics in elective surgery.

Executive summary of the Consensus Document of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) and of the Spanish Association of Surgeons (AEC) in antibiotic prophylaxis in surgery. / Resumen ejecutivo del Documento de Consenso de la Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica (SEIMC) y de la Asociación Española de Cirujanos (AEC) en profilaxis antibiótica en cirugía.

Antibiotic prophylaxis in surgery is one of the most effective measures for preventing surgical site infection, although its use is frequently inadequate and may even increase the risk of infection, toxicities and antimicrobial resistance. As a result of advances in surgical techniques and the emergence of multidrug-resistant organisms, the current guidelines for prophylaxis need to be revised. The Sociedad Española de Enfermedades Infecciosas (Spanish Society of Infectious Diseases and Clinical Microbiology) (SEIMC) together with the Asociación Española de Cirujanos (Spanish Association of Surgeons) (AEC) have revised and updated the recommendations for antibiotic prophylaxis in surgery to adapt them to any type of surgical intervention and to current epidemiology. This document gathers together the recommendations on antimicrobial prophylaxis in the various procedures, with doses, duration, prophylaxis in special patient groups, and in epidemiological settings of multidrug resistance to facilitate standardized management and the safe, effective and rational use of antibiotics in elective surgery.

Trabectedin Plus Radiotherapy for Advanced Soft-Tissue Sarcoma: Experience in Forty Patients Treated at a Sarcoma Reference Center.

Symptomatic control and tumoral shrinkage is an unmet need in advanced soft-tissue sarcoma (STS) patients beyond first-line. The combination of trabectedin and radiotherapy showed activity in a recently reported clinical trial in this setting. This retrospective series aims to analyze our experience with the same regimen in the real-life setting. We retrospectively reviewed advanced sarcoma patients treated with trabectedin concomitantly with radiotherapy with palliative intent. Growth-modulation index (GMI) was calculated as a surrogate of efficacy. Forty metastatic patients were analyzed. According to RECIST, there was one (2.5%) complete response, 12 (30%) partial responses, 18 (45%) disease stabilizations, and nine (22.5%) progressions. After a median follow-up of 15 months (range 2-38), median progression-free survival (PFS) and overall survival (OS) were 7.5 months (95% CI 2.8-12.2) and 23.5 months (95% CI 1.1-45.8), respectively. Median GMI was 1.42 (range 0.19-23.76), and in 16 (53%) patients, it was >1.33. In patients with GMI >1.33, median OS was significantly longer than in those with GMI 0-1.33 (median OS 52.1 months (95% CI not reached) vs. 8.9 months (95% CI 6.3-11.6), p = 0.028). The combination of trabectedin plus radiotherapy is an active therapeutic option in patients with advanced STS, especially when tumor shrinkage for symptomatic relief is needed.

Intraperitoneal hyperthermic chemotherapy after cytoreduction in patients with peritoneal metastases from endometrial cancer. The next frontier?

BACKGROUND: Endometrial cancer is the most common malignancy of the female genital tract. For cancers detected at an advanced stage or intraperitoneal relapse, the prognosis is poor. Optimal cytoreductive surgery (CRS) is the most accepted treatment; however, patients with advanced intraperitoneal disease might benefit from hyperthermic intraoperative peritoneal chemotherapy (HIPEC). The aim of this study was to analyze recurrence-free survival (RFS) after CRS and HIPEC in a large series of patients with peritoneal metastases from endometrial cancer. METHODS: Patients with a diagnosis of endometrial cancer with primary or recurrent peritoneal dissemination were included. All patients underwent CRS plus HIPEC. Data were prospectively collected in the Spanish Group of Peritoneal Oncological Surgery (GECOP) database. RESULTS: Forty-three patients with endometrial cancer and peritoneal metastasis were included. Fifteen patients (35%) were diagnosed with G3 endometrioid carcinomas and 28 (65%) with other non-endometroid histologies. A completeness of cytoreduction score of CC-0 was achieved in 41 patients (95%). RFS at 5 years was 23%, being factors related to worse RFS: treatment with preoperative chemotherapy (p = 0.027), resection of more than three peritoneal areas (p = 0.010), cytoreduction of the upper abdominal space (p = 0.023), HIPEC treatment with paclitaxel (p = 0.013), and the presence of metastatic lymph nodes (p = 0.029). CONCLUSIONS: Better RFS rates after CRS and HIPEC were observed for patients with the following characteristics: cytoreductive surgery without preoperative chemotherapy, complete surgery performed with limited surgical maneuvers, treated with cisplatin, and no lymph node metastases. SYNOPSIS: Endometrial cancer has a poor prognosis when diagnosed at advance stage. Patients with intraperitoneal metastases from endometrial cancer may benefit from CRS plus HIPEC with improvement in the recurrence-free survival results.

Medidas de prevención de la infección de localización quirúrgica en cirugía general. Documento de posicionamiento de la Sección de Infección Quirúrgica de la Asociación Española de Cirujanos / Surgical site infection prevention measures in General Surgery: Position statement by the Surgical Infections Division of the Spanish Association of Surgery

La infección de localización quirúrgica se asocia a prolongación de la estancia hospitalaria, aumento de la morbilidad, mortalidad y gasto sanitario. La adherencia a paquetes sistematizados que incluyan medidas de prevención validadas científicamente consigue disminuir la tasa de infección postoperatoria. La Sección de Infección Quirúrgica de la Asociación Española de Cirujanos ha realizado una revisión crítica de la evidencia científica y las más recientes guías internacionales, para seleccionar las medidas con mayor grado de evidencia a fin de facilitar su aplicación en los servicios de cirugía españoles. Cuentan con mayor grado de evidencia: no eliminación del vello del campo quirúrgico o eliminación con maquinilla eléctrica, descontaminación de la piel con soluciones alcohólicas, profilaxis antibiótica sistémica adecuada (inicio 30-60 minutos antes de la incisión, uso preferente en monodosis, administración de dosis intraoperatoria si indicada), mantenimiento de la normotermia y el control de la glucemia perioperatoria

Surgical site infection is associated with prolonged hospital stay and increased morbidity, mortality and healthcare costs, as well as a poorer patient quality of life. Many hospitals have adopted scientifically-validated guidelines for the prevention of surgical site infection. Most of these protocols have resulted in improved postoperative results. The Surgical Infection Division of the Spanish Association of Surgery conducted a critical review of the scientific evidence and the most recent international guidelines in order to select measures with the highest degree of evidence to be applied in Spanish surgical services. The best measures are: no removal or clipping of hair from the surgical field, skin decontamination with alcohol solutions, adequate systemic antibiotic prophylaxis (administration within 30-60 minutes before the incision in a single preoperative dose; intraoperative re-dosing when indicated), maintenance of normothermia and perioperative maintenance of glucose levels

Surgical site infection prevention measures in General Surgery: Position statement by the Surgical Infections Division of the Spanish Association of Surgery. / Medidas de prevención de la infección de localización quirúrgica en cirugía general. Documento de posicionamiento de la Sección de Infección Quirúrgica de la Asociación Española de Cirujanos.

Surgical site infection is associated with prolonged hospital stay and increased morbidity, mortality and healthcare costs, as well as a poorer patient quality of life. Many hospitals have adopted scientifically-validated guidelines for the prevention of surgical site infection. Most of these protocols have resulted in improved postoperative results. The Surgical Infection Division of the Spanish Association of Surgery conducted a critical review of the scientific evidence and the most recent international guidelines in order to select measures with the highest degree of evidence to be applied in Spanish surgical services. The best measures are: no removal or clipping of hair from the surgical field, skin decontamination with alcohol solutions, adequate systemic antibiotic prophylaxis (administration within 30-60minutes before the incision in a single preoperative dose; intraoperative re-dosing when indicated), maintenance of normothermia and perioperative maintenance of glucose levels.

Actualización en el manejo de sarcomas retroperitoneales y pélvicos; el papel de la cirugía compartimental / Update in pelvic and retroperitoneal sarcoma management: The role of compartment surgery

La cirugía de los sarcomas retroperitoneales debe ser compartimental «en bloque», lo que implica la resección de órganos adyacentes al tumor. Su empleo «de entrada» permite un elevado porcentaje de resecciones con márgenes negativos, lo que supone un mejor control local y mayor supervivencia en muchos pacientes. La preservación de órganos debe hacerse de forma personalizada, especialmente en la pelvis, y adaptarla a la agresividad histológica del tumor. La biopsia preoperatoria permite establecer el subtipo de sarcoma y una adecuada estrategia perioperatoria. Estos pacientes deben ser manejados por cirujanos expertos en centros de referencia, con unidades multidisciplinarias y comités oncológicos. El uso de quimioterapia y radioterapia aún no está bien definido, por lo que solo se recomienda en centros de referencia con ensayos clínicos. En la actualidad esta es la única opción para ofrecer las mejores tasas de morbimortalidad, y las posibles mejoras en la supervivencia de estos pacientes

Surgery for retroperitoneal sarcomas should be "en bloc" compartmental, which involves resection of unaffected organs. Its upfront use is key, providing a high percentage of resections with negative margins, resulting in a better local control and increased survival in many patients. Preservation of organs should be done in an individualized manner, especially in the pelvic location, and adapted to the histological aggressiveness of the tumor. Preoperative biopsy is able to establish the diagnosis of sarcoma subtype and consequently an adequate perioperative strategy. These patients should be managed by expert surgeons at referral centers with multidisciplinary units and oncology committees. The use of chemotherapy and radiotherapy is not yet well defined, so it is only recommended at referral centers with clinical trials. Currently, this is the only option to offer the best morbidity and mortality rates, as well as possible improvements in the survival of these patients

Update in pelvic and retroperitoneal sarcoma management: The role of compartment surgery. / Actualización en el manejo de sarcomas retroperitoneales y pélvicos; el papel de la cirugía compartimental.

Surgery for retroperitoneal sarcomas should be "en bloc" compartmental, which involves resection of unaffected organs. Its upfront use is key, providing a high percentage of resections with negative margins, resulting in a better local control and increased survival in many patients. Preservation of organs should be done in an individualized manner, especially in the pelvic location, and adapted to the histological aggressiveness of the tumor. Preoperative biopsy is able to establish the diagnosis of sarcoma subtype and consequently an adequate perioperative strategy. These patients should be managed by expert surgeons at referral centers with multidisciplinary units and oncology committees. The use of chemotherapy and radiotherapy is not yet well defined, so it is only recommended at referral centers with clinical trials. Currently, this is the only option to offer the best morbidity and mortality rates, as well as possible improvements in the survival of these patients.

The American Society of Peritoneal Surface Malignancies Multi-Institution evaluation of 1,051 advanced ovarian cancer patients undergoing cytoreductive surgery and HIPEC: An introduction of the peritoneal surface disease severity score.

BACKGROUND: Standard treatment for ovarian epithelial cancer (OEC) consists of cytoreductive surgery (CRS) and a platinum-taxane chemotherapy combination. There is increasing interest in evaluating hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with stage IIIC/IV disease. The peritoneal surface disease severity score (PSDSS) was introduced as a basis to improve patient selection for this therapy in OEC. METHODS: The charts of 1,051 patients with advanced OEC who underwent CRS/HIPEC were retrospectively evaluated using the following preoperatively obtained criteria: symptoms, peritoneal dissemination, and tumor histology. Overall survival was analyzed according to PSDSS as well as the timings and agents used during CRS/HIPEC. RESULTS: Median survival for all 1,051 patients was 73.4 months. PSDSS information was available for 553 patients. Survival correlated negatively with PSDSS (P < 0.001). Furthermore, combining PSDSS scores into I/II and III/IV described two distinct patient populations with vastly different outcomes, 100 versus 55 months, respectively (P < 0.001). Multivariate analysis failed to describe any differences between timings of HIPEC or chemotherapy agents used. CONCLUSION: PSDSS was capable of identifying a better surviving patient population in advanced-stage OEC. While randomized trials to evaluate the benefit of HIPEC are needed, the PSDSS may be a useful tool for selecting and stratifying OEC patients in clinical trials. J. Surg. Oncol. 2016;114:779-784. © 2016 2016 Wiley Periodicals, Inc.

Estudio cooperativo del Grupo Español de Trasplante de Páncreas (GETP): complicaciones quirúrgicas / Cooperative study of the Spanish Pancreas Transplant Group (GETP): Surgical complications

El fracaso técnico en el trasplante de páncreas ha sido el principal responsable de la pérdida de los injertos. Desde hace unos años, el número de complicaciones se han reducido, y por tanto, la proporción de este problema. Objetivos El Grupo Español del Trasplante de Páncreas se plantea como objetivo de este estudio analizar la situación actual con relación a las complicaciones quirúrgicas y su gravedad. Material y métodos Se ha realizado un estudio retrospectivo y multicéntrico con 10 centros participantes, con un total de 410 pacientes trasplantados de páncreas entre enero de 2008 y diciembre de 2013. Resultados Un total de 316 trasplantes fueron simultáneos con riñón, 66 después de riñón, 10 solo de páncreas, 7 multiviscerales y 11 retrasplantes. El porcentaje de complicaciones quirúrgicas fue del 39% (161 pacientes). Un 7% de trombosis vasculares, 13% de hemorragias, 6% de pancreatitis del injerto, 12% de infecciones quirúrgicas y otras en menor proporción. Las reintervenciones alcanzaron el 25%. La gravedad de las complicaciones fueron del tipo iiib (13%), del tipo ii (12%) y del tipo iva (8,5%). La pérdida del injerto fue del 8%. La mortalidad precoz del 0,5%. Las operaciones por complicaciones tardías fueron el 17%. Conclusiones El número de complicaciones quirúrgicas tras el trasplante no es desdeñable: afectan a uno de cada 3 pacientes, son graves en uno de cada 5 y con pérdida del injerto en uno de cada 10 pacientes. Por tanto, sigue existiendo un porcentaje significativo de complicaciones quirúrgicas en este tipo de actividad, como se demuestra en nuestro país

Technical failure in pancreas transplant has been the main cause of the loss of grafts. In the last few years, the number of complications has reduced, and therefore the proportion of this problem. Objetives The Spanish Pancreas Transplant Group wanted to analyze the current situation with regard to surgical complications and their severity. Material and methods A retrospective and multicenter study was performed. 10 centers participated, with a total of 410 pancreas transplant recipients between January and December 2013. Results A total of 316 transplants were simultaneous with kidney, 66 after kidney, pancreas-only 10, 7 multivisceral and 11 retrasplants. Surgical complication rates were 39% (n = 161). A total of 7% vascular thrombosis, 13% bleeding, 6% the graft pancreatitis, 12% surgical infections and others to a lesser extent. Relaparotomy rate was 25%. The severity of complications were of type IIIB (13%), type II (12%) and type IVA (8.5%). Graft loss was 8%. Early mortality was 0.5%. The percentage of operations for late complications was 17%. Conclusions The number of surgical complications after transplantation is not negligible, affecting one in 3 patients. They are severe in one out of 5 and, in one of every 10 patients graft loss occurs. Therefore, there is still a significant percentage of surgical complications in this type of activity, as shown in our country