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2.
Int J Surg ; 110(4): 2226-2233, 2024 Apr 01.
Artículo en Inglés | MEDLINE | ID: mdl-38265434

RESUMEN

BACKGROUND: International multicenter audit-based studies focusing on the outcome of minimally invasive pancreatoduodenectomy (MIPD) are lacking. The European Registry for Minimally Invasive Pancreatic Surgery (E-MIPS) is the E-AHPBA endorsed registry aimed to monitor and safeguard the introduction of MIPD in Europe. MATERIALS AND METHODS: A planned analysis of outcomes among consecutive patients after MIPD from 45 centers in 14 European countries in the E-MIPS registry (2019-2021). The main outcomes of interest were major morbidity (Clavien-Dindo grade ≥3) and 30-day/in-hospital mortality. RESULTS: Overall, 1336 patients after MIPD were included [835 robot-assisted (R-MIPD) and 501 laparoscopic MIPD (L-MIPD)]. Overall, 20 centers performed R-MIPD, 15 centers L-MIPD, and 10 centers both. Between 2019 and 2021, the rate of centers performing L-MIPD decreased from 46.9 to 25%, whereas for R-MIPD this increased from 46.9 to 65.6%. Overall, the rate of major morbidity was 41.2%, 30-day/in-hospital mortality 4.5%, conversion rate 9.7%, postoperative pancreatic fistula grade B/C 22.7%, and postpancreatectomy hemorrhage grade B/C 10.8%. Median length of hospital stay was 12 days (IQR 8-21). A lower rate of major morbidity, postoperative pancreatic fistula grade B/C, postpancreatectomy hemorrhage grade B/C, delayed gastric emptying grade B/C, percutaneous drainage, and readmission was found after L-MIPD. The number of centers meeting the Miami Guidelines volume cut-off of ≥20 MIPDs annually increased from 9 (28.1%) in 2019 to 12 (37.5%) in 2021 ( P =0.424). Rates of conversion (7.4 vs. 14.8% P <0.001) and reoperation (8.9 vs. 15.1% P <0.001) were lower in centers, which fulfilled the Miami volume cut-off. CONCLUSION: During the first 3 years of the pan-European E-MIPS registry, morbidity and mortality rates after MIPD were acceptable. A shift is ongoing from L-MIPD to R-MIPD. Variations in outcomes between the two minimally invasive approaches and the impact of the volume cut-off should be further evaluated over a longer time period.


Asunto(s)
Laparoscopía , Pancreaticoduodenectomía , Sistema de Registros , Humanos , Pancreaticoduodenectomía/métodos , Pancreaticoduodenectomía/efectos adversos , Pancreaticoduodenectomía/mortalidad , Sistema de Registros/estadística & datos numéricos , Masculino , Europa (Continente) , Femenino , Anciano , Persona de Mediana Edad , Estudios Retrospectivos , Laparoscopía/efectos adversos , Laparoscopía/mortalidad , Laparoscopía/métodos , Laparoscopía/estadística & datos numéricos , Complicaciones Posoperatorias/epidemiología , Procedimientos Quirúrgicos Robotizados/efectos adversos , Procedimientos Quirúrgicos Robotizados/mortalidad , Procedimientos Quirúrgicos Robotizados/métodos , Procedimientos Quirúrgicos Robotizados/estadística & datos numéricos , Mortalidad Hospitalaria , Resultado del Tratamiento , Procedimientos Quirúrgicos Mínimamente Invasivos/métodos , Procedimientos Quirúrgicos Mínimamente Invasivos/efectos adversos
3.
J Gastroenterol Hepatol ; 39(4): 674-684, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38191176

RESUMEN

BACKGROUND AND AIM: More insight into the incidence of and factors associated with progression following a first episode of acute pancreatitis (AP) would offer opportunities for improvements in disease management and patient counseling. METHODS: A long-term post hoc analysis of a prospective cohort of patients with AP (2008-2015) was performed. Primary endpoints were recurrent acute pancreatitis (RAP), chronic pancreatitis (CP), and pancreatic cancer. Cumulative incidence calculations and risk analyses were performed. RESULTS: Overall, 1184 patients with a median follow-up of 9 years (IQR: 7-11) were included. RAP and CP occurred in 301 patients (25%) and 72 patients (6%), with the highest incidences observed for alcoholic pancreatitis (40% and 22%). Pancreatic cancer was diagnosed in 14 patients (1%). Predictive factors for RAP were alcoholic and idiopathic pancreatitis (OR 2.70, 95% CI 1.51-4.82 and OR 2.06, 95% CI 1.40-3.02), and no pancreatic interventions (OR 1.82, 95% CI 1.10-3.01). Non-biliary etiology (alcohol: OR 5.24, 95% CI 1.94-14.16, idiopathic: OR 4.57, 95% CI 2.05-10.16, and other: OR 2.97, 95% CI 1.11-7.94), RAP (OR 4.93, 95% CI 2.84-8.58), prior pancreatic interventions (OR 3.10, 95% CI 1.20-8.02), smoking (OR 2.33, 95% CI 1.14-4.78), and male sex (OR 2.06, 95% CI 1.05-4.05) were independently associated with CP. CONCLUSION: Disease progression was observed in a quarter of pancreatitis patients. We identified several risk factors that may be helpful to devise personalized strategies with the intention to reduce the impact of disease progression in patients with AP.


Asunto(s)
Enfermedades Pancreáticas , Neoplasias Pancreáticas , Pancreatitis Crónica , Humanos , Masculino , Enfermedad Aguda , Progresión de la Enfermedad , Estudios de Seguimiento , Recurrencia Local de Neoplasia/complicaciones , Enfermedades Pancreáticas/complicaciones , Neoplasias Pancreáticas/etiología , Neoplasias Pancreáticas/complicaciones , Pancreatitis Crónica/complicaciones , Pancreatitis Crónica/epidemiología , Estudios Prospectivos , Recurrencia , Factores de Riesgo
4.
BMC Cancer ; 23(1): 728, 2023 Aug 07.
Artículo en Inglés | MEDLINE | ID: mdl-37550634

RESUMEN

BACKGROUND: Surgical resection followed by adjuvant mFOLFIRINOX (5-fluorouracil with leucovorin, irinotecan, and oxaliplatin) is currently the standard of care for patients with resectable pancreatic cancer. The main concern regarding adjuvant chemotherapy is that only half of patients actually receive adjuvant treatment. Neoadjuvant chemotherapy, on the other hand, guarantees early systemic treatment and may increase chemotherapy use and thereby improve overall survival. Furthermore, it may prevent futile surgery in patients with rapidly progressive disease. However, some argue that neoadjuvant therapy delays surgery, which could lead to progression towards unresectable disease and thus offset the potential benefits. Comparison of perioperative (i.e., neoadjuvant and adjuvant) with (only) adjuvant administration of mFOLFIRINOX in a randomized controlled trial (RCT) is needed to determine the optimal approach. METHODS: This multicenter, phase 3, RCT will include 378 patients with resectable pancreatic ductal adenocarcinoma with a WHO performance status of 0 or 1. Patients are recruited from 20 Dutch centers and three centers in Norway and Sweden. Resectable pancreatic cancer is defined as no arterial contact and ≤ 90 degrees venous contact. Patients in the intervention arm are scheduled for 8 cycles of neoadjuvant mFOLFIRINOX followed by surgery and 4 cycles of adjuvant mFOLFIRINOX (2-week cycle of oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, irinotecan 150 mg/m2 at day 1, followed by 46 h continuous infusion of 5-fluorouracil 2400 g/m2). Patients in the comparator arm start with surgery followed by 12 cycles of adjuvant mFOLFIRINOX. The primary outcome is overall survival by intention-to-treat. Secondary outcomes include progression-free survival, resection rate, quality of life, adverse events, and surgical complications. To detect a hazard ratio of 0.70 with 80% power, 252 events are needed. The number of events is expected to be reached after the inclusion of 378 patients in 36 months, with analysis planned 18 months after the last patient has been randomized. DISCUSSION: The multicenter PREOPANC-3 trial compares perioperative mFOLFIRINOX with adjuvant mFOLFIRINOX in patients with resectable pancreatic cancer. TRIAL REGISTRATION: Clinical Trials: NCT04927780. Registered June 16, 2021.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica , Neoplasias Pancreáticas , Humanos , Irinotecán/uso terapéutico , Oxaliplatino/uso terapéutico , Leucovorina/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Neoplasias Pancreáticas/tratamiento farmacológico , Neoplasias Pancreáticas/cirugía , Fluorouracilo/uso terapéutico , Terapia Neoadyuvante/métodos , Quimioterapia Adyuvante , Adyuvantes Inmunológicos/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como Asunto , Neoplasias Pancreáticas
5.
J Therm Biol ; 115: 103619, 2023 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-37437370

RESUMEN

INTRODUCTION: Irreversible electroporation (IRE) is an ablation modality that applies short, high-voltage electric pulses to unresectable cancers. Although considered a non-thermal technique, temperatures do increase during IRE. This temperature rise sensitizes tumor cells for electroporation as well as inducing partial direct thermal ablation. AIM: To evaluate the extent to which mild and moderate hyperthermia enhance electroporation effects, and to establish and validate in a pilot study cell viability models (CVM) as function of both electroporation parameters and temperature in a relevant pancreatic cancer cell line. METHODS: Several IRE-protocols were applied at different well-controlled temperature levels (37 °C ≤ T ≤ 46 °C) to evaluate temperature dependent cell viability at enhanced temperatures in comparison to cell viability at T = 37 °C. A realistic sigmoid CVM function was used based on thermal damage probability with Arrhenius Equation and cumulative equivalent minutes at 43 °C (CEM43°C) as arguments, and fitted to the experimental data using "Non-linear-least-squares"-analysis. RESULTS: Mild (40 °C) and moderate (46 °C) hyperthermic temperatures boosted cell ablation with up to 30% and 95%, respectively, mainly around the IRE threshold Eth,50% electric-field strength that results in 50% cell viability. The CVM was successfully fitted to the experimental data. CONCLUSION: Both mild- and moderate hyperthermia significantly boost the electroporation effect at electric-field strengths neighboring Eth,50%. Inclusion of temperature in the newly developed CVM correctly predicted both temperature-dependent cell viability and thermal ablation for pancreatic cancer cells exposed to a relevant range of electric-field strengths/pulse parameters and mild moderate hyperthermic temperatures.


Asunto(s)
Hipertermia Inducida , Neoplasias Pancreáticas , Humanos , Proyectos Piloto , Electroporación/métodos , Temperatura , Neoplasias Pancreáticas/terapia
6.
Front Oncol ; 13: 1149961, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37324027

RESUMEN

Background: The role of stereotactic ablative radiation therapy (SABR) as local treatment option after chemotherapy for locally advanced pancreatic cancer (LAPC) is evolving. However adequate patient selection criteria for SABR in patients with LAPC are lacking. Methods: A prospective institutional database collected data of patients with LAPC treated with chemotherapy, mainly FOLFIRINOX, followed by SABR, which was delivered using magnetic resonance guided radiotherapy, 40 Gy in 5 fractions within two weeks. Primary endpoint was overall survival (OS). Cox regression analyses were performed to identify predictors for OS. Results: Overall, 74 patients were included, median age 66 years, 45.9% had a KPS score of ≥90. Median OS was 19.6 months from diagnosis and 12.1 months from start of SABR. Local control was 90% at one year. Multivariable Cox regression analyses identified KPS ≥90, age <70, and absence of pain prior to SABR as independent favorable predictors for OS. The rate of grade ≥3 fatigue and late gastro-intestinal toxicity was 2.7%. Conclusions: SABR is a well-tolerated treatment in patients with unresectable LAPC following chemotherapy, with better outcomes when applied in patients with higher performance score, age <70 years and absence of pain. Future randomized trials will have to confirm these findings.

8.
Surg Open Sci ; 12: 1-8, 2023 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-36747974

RESUMEN

Background: Due to centralization and super-specialization in medicine, hospital mergers are increasingly common. Their effect on postoperative outcomes in highly specialized surgical departments is unclear. As quality metrics often worsen after major organizational changes, preservation of quality of care during an hospital merge is of the utmost importance. Objective: To evaluate the effect of a merger of two Dutch university hospitals on quality of surgical care, volume, and timeliness of care. Methods: The upper gastro-intestinal and hepato-biliary-pancreatic sections merged on the 27th of January 2020 and the 31th of May 2021 respectively. Outcomes of all adult surgical patients were compared six months before and six months after the merger. Short-term quality metrics, volume, and timeliness of care were assessed. Results: Overall, a cohort of 631 patients were included of whom 195 were upper gastro-intestinal (97 prior to the merger, 98 after the merger) and 436 (223 prior to the merger, 213 after) hepato-biliary-pancreatic patients. There were no differences in mortality, readmission, number and severity of complications, volume, and timeliness of care six months post-merger as compared to before merger. Conclusion: This study shows that a hospital merger of two university hospitals can be performed without jeopardizing patient safety and while benefitting from centralization of highly specialized care and enhancement of medical research. Key message: This study investigated the impact of a merger of two Dutch university hospitals on quality of care, timeliness of care, and volume. It showed no deterioration in the evaluated short-term quality metrics, volume or timeliness for upper GI and HPB surgery, suggesting that a hospital merger of two university hospitals can be performed safely, while benefitting from centralization of highly specialized care and enhancement of medical research.

11.
Surg Endosc ; 37(4): 2659-2672, 2023 04.
Artículo en Inglés | MEDLINE | ID: mdl-36401105

RESUMEN

BACKGROUND: Many centers worldwide are shifting from laparoscopic to robotic minimally invasive hepato-pancreato-biliary resections (MIS-HPB) but large single center series assessing this process are lacking. We hypothesized that the introduction of robot-assisted surgery was safe and feasible in a high-volume center. METHODS: Single center, post-hoc assessment of prospectively collected data including all consecutive MIS-HPB resections (January 2010-February 2022). As of December 2018, all MIS pancreatoduodenectomy and liver resections were robot-assisted. All surgeons had participated in dedicated training programs for laparoscopic and robotic MIS-HPB. Primary outcomes were in-hospital/30-day mortality and Clavien-Dindo ≥ 3 complications. RESULTS: Among 1875 pancreatic and liver resections, 600 (32%) were MIS-HPB resections. The overall rate of conversion was 4.3%, Clavien-Dindo ≥ 3 complications 25.7%, and in-hospital/30-day mortality 1.8% (n = 11). When comparing the period before and after the introduction of robotic MIS-HPB (Dec 2018), the overall use of MIS-HPB increased from 25.3 to 43.8% (P < 0.001) and blood loss decreased from 250 ml [IQR 100-500] to 150 ml [IQR 50-300] (P < 0.001). The 291 MIS pancreatic resections included 163 MIS pancreatoduodenectomies (52 laparoscopic, 111 robotic) with 4.3% conversion rate. The implementation of robotic pancreatoduodenectomy was associated with reduced operation time (450 vs 361 min; P < 0.001), reduced blood loss (350 vs 200 ml; P < 0.001), and a decreased rate of delayed gastric emptying (28.8% vs 9.9%; P = 0.009). The 309 MIS liver resections included 198 laparoscopic and 111 robotic procedures with a 3.6% conversion rate. The implementation of robotic liver resection was associated with less overall complications (24.7% vs 10.8%; P = 0.003) and shorter hospital stay (4 vs 3 days; P < 0.001). CONCLUSION: The introduction of robotic surgery was associated with greater implementation of MIS-HPB in up to nearly half of all pancreatic and liver resections. Although mortality and major morbidity were not affected, robotic surgery was associated with improvements in some selected outcomes. Ultimately, randomized studies and high-quality registries should determine its added value.


Asunto(s)
Laparoscopía , Procedimientos Quirúrgicos Robotizados , Humanos , Hepatectomía/métodos , Hígado/cirugía , Procedimientos Quirúrgicos Mínimamente Invasivos , Páncreas/cirugía , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/cirugía , Estudios Prospectivos
13.
J Vis Exp ; (202)2023 Dec 15.
Artículo en Inglés | MEDLINE | ID: mdl-38163262

RESUMEN

Duodenal stenosis is a condition that can be related to several diseases, being either intrinsic, such as neoplasm and inflammatory stenosis, or extrinsic, such as pancreatic pseudocyst, superior mesenteric artery syndrome, and foreign bodies. Current treatments range from endoscopic approaches, such as endoscopic resection and stent placement, to surgical approaches, including duodenal resection, pancreaticoduodenectomy, and gastrointestinal bypass. Minimally invasive robot-assisted surgery is gaining importance due to its potential to decrease surgical stress, intraoperative blood loss, and postoperative pain, while its instruments and 3D-vision facilitate fine dissection and intra-abdominal suturing, all leading to a reduced time to functional recovery and shorter hospital stay. We present a case of a 75-year-old female who underwent robotic D3 partial duodenal resection with primary side-to-side duodeno-jejunal anastomosis for a 5 cm adenoma with focal high-grade dysplasia.


Asunto(s)
Laparoscopía , Procedimientos Quirúrgicos Robotizados , Robótica , Femenino , Humanos , Anciano , Duodeno/cirugía , Anastomosis Quirúrgica , Pancreaticoduodenectomía
14.
BMC Cancer ; 22(1): 1363, 2022 Dec 29.
Artículo en Inglés | MEDLINE | ID: mdl-36581914

RESUMEN

BACKGROUND: Significant comorbidities, advanced age, and a poor performance status prevent surgery and systemic treatment for many patients with localized (non-metastatic) pancreatic ductal adenocarcinoma (PDAC). These patients are currently treated with 'best supportive care'. Therefore, it is desirable to find a treatment option which could improve both disease control and quality of life in these patients. A brief course of high-dose high-precision radiotherapy i.e. stereotactic ablative body radiotherapy (SABR) may be feasible. METHODS: A nationwide multicenter trial performed within a previously established large prospective cohort (the Dutch Pancreatic cancer project; PACAP) according to the 'Trial within cohorts' (TwiCs) design. Patients enrolled in the PACAP cohort routinely provide informed consent to answer quality of life questionnaires and to be randomized according to the TwiCs design when eligible for a study. Patients with localized PDAC who are unfit for chemotherapy and surgery or those who refrain from these treatments are eligible. Patients will be randomized between SABR (5 fractions of 8 Gy) with 'best supportive care' and 'best supportive care' only. The primary endpoint is overall survival from randomization. Secondary endpoints include preservation of quality of life (EORTC-QLQ-C30 and -PAN26), NRS pain score response and WHO performance scores at baseline, and, 3, 6 and 12 months. Acute and late toxicity will be scored using CTCAE criteria version 5.0: assessed at baseline, day of last fraction, at 3 and 6 weeks, and 3, 6 and 12 months following SABR. DISCUSSION: The PANCOSAR trial studies the added value of SBRT as compared to 'best supportive care' in patients with localized PDAC who are medically unfit to receive chemotherapy and surgery, or refrain from these treatments. This study will assess whether SABR, in comparison to best supportive care, can relieve or delay tumor-related symptoms, enhance quality of life, and extend survival in these patients. TRIAL REGISTRATION: Clinical trials, NCT05265663 , Registered March 3 2022, Retrospectively registered.


Asunto(s)
Adenocarcinoma , Neoplasias Pancreáticas , Radiocirugia , Humanos , Adenocarcinoma/etiología , Neoplasias Pancreáticas/radioterapia , Neoplasias Pancreáticas/etiología , Polipéptido Hipofisario Activador de la Adenilato-Ciclasa , Estudios Prospectivos , Calidad de Vida , Neoplasias Pancreáticas
15.
J Med Case Rep ; 16(1): 356, 2022 Oct 05.
Artículo en Inglés | MEDLINE | ID: mdl-36195885

RESUMEN

BACKGROUND: Pancreatic panniculitis is characterized by subcutaneous fat necrosis and is a rare presentation of an underlying pancreatic disease, appearing in approximately 2-3% of all patients with a pancreatic disease. The nodules usually involve the lower extremities. Pancreatic panniculitis is commonly associated with acute or chronic pancreatitis, and occasionally with pancreatic cancer, especially acinar cell carcinoma. CASE PRESENTATION: A 77-year-old Caucasian woman with no significant medical history was referred to our center with multiple painful, itchy, and warm red/blue cutaneous nodules on the left lower leg. These skin lesions were consistent with the clinical diagnosis of panniculitis. The skin biopsy obtained showed a predominantly lobular panniculitis with fat necrosis of which the aspect was highly suspicious for pancreatic panniculitis. Further analysis revealed high lipase serum of > 3000 U/L (normal range < 60 U/L), and on computed tomography scan a mass located between the stomach and the left pancreas was seen. Endoscopic ultrasonography-guided fine-needle biopsy confirmed the diagnosis of acinar cell carcinoma. After discussing the patient in the pancreatobiliary multidisciplinary team meeting, laparoscopic distal pancreatectomy including splenectomy and en bloc wedge resection of the stomach due to tumor in-growth was performed. The cutaneous nodules on both legs disappeared 1-2 days after surgery. No long-term complications were reported during follow-up. One year after surgery, the patient presented with similar symptoms as preoperatively. Computed tomography scan showed local recurrence and distal metastases, which were subsequently confirmed by biopsy. She started with palliative folinic acid-fluorouracil-irinotecan-oxaliplatin chemotherapy but stopped after two cycles because of disease progression. The patient died 2 months later, 13 months after surgical resection. CONCLUSION: This case illustrates the importance of clinically recognizing cutaneous nodules and pathological recognizing the specific microscopic changes as sign of a (malignant) pancreatic disease.


Asunto(s)
Carcinoma de Células Acinares , Enfermedades Pancreáticas , Neoplasias Pancreáticas , Paniculitis , Células Acinares/patología , Anciano , Carcinoma de Células Acinares/complicaciones , Carcinoma de Células Acinares/diagnóstico , Carcinoma de Células Acinares/cirugía , Femenino , Fluorouracilo , Humanos , Irinotecán , Leucovorina , Lipasa , Extremidad Inferior/patología , Oxaliplatino , Enfermedades Pancreáticas/patología , Neoplasias Pancreáticas/complicaciones , Neoplasias Pancreáticas/diagnóstico , Neoplasias Pancreáticas/cirugía , Neoplasias Pancreáticas
16.
Trials ; 23(1): 913, 2022 Oct 28.
Artículo en Inglés | MEDLINE | ID: mdl-36307892

RESUMEN

BACKGROUND: Disease recurrence is the main cause of mortality after resection of pancreatic ductal adenocarcinoma (PDAC). In 20-30% of resected patients, isolated local PDAC recurrence occurs. Retrospective studies have suggested that stereotactic body radiation therapy (SBRT) might lead to improved local control in these patients, potentially having a beneficial effect on both survival and quality of life. The "nationwide randomized controlled trial on additional treatment for isolated local pancreatic cancer recurrence using stereotactic body radiation therapy" (ARCADE) will investigate the value of SBRT in addition to standard of care in patients with isolated local PDAC recurrence compared to standard of care alone, regarding both survival and quality of life outcomes. METHODS: The ARCADE trial is nested within a prospective cohort (Dutch Pancreatic Cancer Project; PACAP) according to the 'Trials within Cohorts' design. All PACAP participants with isolated local PDAC recurrence after primary resection who provided informed consent for being randomized in future studies are eligible. Patients will be randomized for local therapy (5 fractions of 8 Gy SBRT) in addition to standard of care or standard of care alone. In total, 174 patients will be included. The main study endpoint is survival after recurrence. The most important secondary endpoint is quality of life. DISCUSSION: It is hypothesized that additional SBRT, compared to standard of care alone, improves survival and quality of life in patients with isolated local recurrence after PDAC resection. TRIAL REGISTRATION: ClinicalTrials.gov registration NCT04881487 . Registered on May 11, 2021.


Asunto(s)
Carcinoma Ductal Pancreático , Neoplasias Pancreáticas , Radiocirugia , Humanos , Radiocirugia/efectos adversos , Estudios Retrospectivos , Estudios Prospectivos , Calidad de Vida , Polipéptido Hipofisario Activador de la Adenilato-Ciclasa , Recurrencia Local de Neoplasia/patología , Neoplasias Pancreáticas/radioterapia , Neoplasias Pancreáticas/cirugía , Carcinoma Ductal Pancreático/radioterapia , Carcinoma Ductal Pancreático/cirugía , Neoplasias Pancreáticas
17.
Trials ; 23(1): 809, 2022 Sep 24.
Artículo en Inglés | MEDLINE | ID: mdl-36153559

RESUMEN

BACKGROUND: Prophylactic abdominal drainage is current standard practice after distal pancreatectomy (DP), with the aim to divert pancreatic fluid in case of a postoperative pancreatic fistula (POPF) aimed to prevent further complications as bleeding. Whereas POPF after pancreatoduodenectomy, by definition, involves infection due to anastomotic dehiscence, a POPF after DP is essentially sterile since the bowel is not opened and no anastomoses are created. Routine drainage after DP could potentially be omitted and this could even be beneficial because of the hypothetical prevention of drain-induced infections (Fisher, Surgery 52:205-22, 2018). Abdominal drainage, moreover, should only be performed if it provides additional safety or comfort to the patient. In clinical practice, drains cause clear discomfort. One multicenter randomized controlled trial confirmed the safety of omitting abdominal drainage but did not stratify patients according to their risk of POPF and did not describe a standardized strategy for pancreatic transection. Therefore, a large pragmatic multicenter randomized controlled trial is required, with prespecified POPF risk groups and a homogeneous method of stump closure. The objective of the PANDORINA trial is to evaluate the non-inferiority of omitting routine intra-abdominal drainage after DP on postoperative morbidity (Clavien-Dindo score ≥ 3), and, secondarily, POPF grade B/C. METHODS/DESIGN: Binational multicenter randomized controlled non-inferiority trial, stratifying patients to high and low risk for POPF grade B/C and incorporating a standardized strategy for pancreatic transection. Two groups of 141 patients (282 in total) undergoing elective DP (either open or minimally invasive, with or without splenectomy). Primary outcome is postoperative rate of morbidity (Clavien-Dindo score ≥ 3), and the most relevant secondary outcome is grade B/C POPF. Other secondary outcomes include surgical reintervention, percutaneous catheter drainage, endoscopic catheter drainage, abdominal collections (not requiring drainage), wound infection, delayed gastric emptying, postpancreatectomy hemorrhage as defined by the international study group for pancreatic surgery (ISGPS) (Wente et al., Surgery 142:20-5, 2007), length of stay (LOS), readmission within 90 days, in-hospital mortality, and 90-day mortality. DISCUSSION: PANDORINA is the first binational, multicenter, randomized controlled non-inferiority trial with the primary objective to evaluate the hypothesis that omitting prophylactic abdominal drainage after DP does not worsen the risk of postoperative severe complications (Wente etal., Surgery 142:20-5, 2007; Bassi et al., Surgery 161:584-91, 2017). Most of the published studies on drain placement after pancreatectomy focus on both pancreatoduodenectomy and DP, but these two entities present are associated with different complications and therefore deserve separate evaluation (McMillan et al., Surgery 159:1013-22, 2016; Pratt et al., J Gastrointest Surg 10:1264-78, 2006). The PANDORINA trial is innovative since it takes the preoperative risk on POPF into account based on the D-FRS and it warrants homogenous stump closing by using the same graded compression technique and same stapling device (de Pastena et al., Ann Surg 2022; Asbun and Stauffer, Surg Endosc 25:2643-9, 2011).


Asunto(s)
Pancreatectomía , Fístula Pancreática , Abdomen/cirugía , Drenaje/métodos , Humanos , Páncreas/cirugía , Pancreatectomía/efectos adversos , Pancreatectomía/métodos , Fístula Pancreática/etiología , Fístula Pancreática/prevención & control , Fístula Pancreática/cirugía , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/prevención & control , Complicaciones Posoperatorias/cirugía , Estudios Retrospectivos
18.
Surg Oncol ; 44: 101841, 2022 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-36087543

RESUMEN

BACKGROUND: Ampullary adenocarcinoma (AAC) is a rare neoplasm which as a result is lacking specific treatment guidelines. This international survey study was performed to gain insight in the current daily practice of AAC. METHODS: Surgeons and medical oncologists, whom were members of the Dutch Pancreatic Cancer Group, International Study Group on Ampullary Cancer, International Hepato-Pancreato-Biliary Association, European and International Consortium on Minimally Invasive Pancreatic Surgery, or contributed to (peri)ampullary cancer research, were invited through email and newsletters between January and October 2021. RESULTS: Overall, 217 surgeons and medical oncologists completed the survey. Most of the respondents work in Europe (60%), and in a pancreatic expertise center (86%). The majority of respondents (87%) stated that the histological AAC subtype (e.g. intestinal vs. pancreatobiliary) was determined in the resection specimen. Neoadjuvant treatment for resectable disease was considered by 24% and adjuvant therapy by 90% of the respondents, with 80% of them choosing adjuvant chemotherapy alone. The formation of multidisciplinary teams, improvement in resection procedures, increased availability of chemotherapy regimens, and increased knowledge on tumor biology were considered as the most important developments in the last five years. The necessity for randomized controlled trials was mentioned by 50% of the respondents. CONCLUSIONS: This international survey highlights the existing variation in the management of patients with AAC, especially regarding the use of (neo)adjuvant therapy. More data from trials and international registries are needed to develop evidence-based guidelines on surgical and oncological management with the ultimate aim to improve outcomes for patients with AAC.


Asunto(s)
Adenocarcinoma , Ampolla Hepatopancreática , Neoplasias del Conducto Colédoco , Neoplasias Duodenales , Oncólogos , Neoplasias Pancreáticas , Adenocarcinoma/patología , Adenocarcinoma/cirugía , Ampolla Hepatopancreática/patología , Ampolla Hepatopancreática/cirugía , Neoplasias del Conducto Colédoco/patología , Neoplasias del Conducto Colédoco/cirugía , Neoplasias Duodenales/patología , Humanos , Neoplasias Pancreáticas/cirugía , Encuestas y Cuestionarios , Neoplasias Pancreáticas
19.
Pancreatology ; 22(7): 1020-1027, 2022 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-35961936

RESUMEN

BACKGROUND/OBJECTIVES: Pancreatic exocrine insufficiency (PEI) is a common complication following pancreatoduodenectomy (PD) leading to malnutrition. The course of PEI and related symptoms and vitamin deficiencies is unknown. This study aimed to assess the (long-term) incidence of PEI and vitamin deficiencies after PD. METHODS: A bi-centre prospective observational cohort study was performed, including patients who underwent PD for mainly pancreatic and periampullary (pre)malignancies (2014-2018). Two cohorts were formed to evaluate short and long-term results. Patients were followed for 18 months and clinical symptoms were evaluated by questionnaire. PEI was based on faecal elastase-1 (FE-1) levels and/or clinical symptoms. RESULTS: In total, 95 patients were included. After three months, all but three patients had developed PEI and 27/29 (93%) patients of whom stool samples were available showed abnormal FE-1 levels, which did not improve during follow-up. After six months, all patients had developed PEI. During follow-up, symptoms resolved in 35%-70% of patients. Vitamin D and K deficiencies were observed in 48%-79% of patients, depending on the moment of follow-up; 0%-50% of the patients with deficiencies received vitamin supplementation. DISCUSSION: This prospective study found a high incidence of PEI after PD with persisting symptoms in one-to two thirds of all patients. Limited attention was paid to vitamin deficiencies. Improved screening and treatment strategies for PEI and vitamins need to be designed.


Asunto(s)
Insuficiencia Pancreática Exocrina , Pancreaticoduodenectomía , Humanos , Pancreaticoduodenectomía/efectos adversos , Estudios Prospectivos , Insuficiencia Pancreática Exocrina/epidemiología , Insuficiencia Pancreática Exocrina/etiología , Insuficiencia Pancreática Exocrina/diagnóstico , Páncreas , Vitamina A
20.
Eur J Surg Oncol ; 48(2): 348-355, 2022 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-34366174

RESUMEN

BACKGROUND: This study aims to assess the impact of nationwide centralization of surgery on travel distance and travel burden among patients with oesophageal, gastric, and pancreatic cancer according to age in the Netherlands. As centralization of care increases to improve postoperative outcomes, travel distance and experienced burden might increase. MATERIALS AND METHODS: All patients who underwent surgery between 2006 and 2017 for oesophageal, gastric and pancreatic cancer in the Netherlands were included. Travel distance between patient's home address and hospital of surgery in kilometres was calculated. Questionnaires were used to assess experienced travel burden in a subpopulation (n = 239). Multivariable ordinal logistic regression models were constructed to identify predictors for longer travel distance. RESULTS: Over 23,838 patients were included, in whom median travel distance for surgical care increased for oesophageal cancer (n = 9217) from 18 to 28 km, for gastric cancer (n = 6743) from 9 to 26 km, and for pancreatic cancer (n = 7878) from 18 to 25 km (all p < 0.0001). Multivariable analyses showed an increase in travel distance for all cancer types over time. In general, patients experienced a physical and social burden, and higher financial costs, due to traveling extra kilometres. Patients aged >70 years travelled less often independently (56% versus 68%), as compared to patients aged ≤70 years. CONCLUSION: With nationwide centralization, travel distance increased for patients undergoing oesophageal, gastric, and pancreatic cancer surgery. Younger patients travelled longer distances and experienced a lower travel burden, as compared to elderly patients. Nevertheless, on a global scale, travel distances in the Netherlands remain limited.


Asunto(s)
Costo de Enfermedad , Procedimientos Quirúrgicos del Sistema Digestivo , Neoplasias Esofágicas/cirugía , Accesibilidad a los Servicios de Salud , Neoplasias Pancreáticas/cirugía , Neoplasias Gástricas/cirugía , Oncología Quirúrgica/organización & administración , Viaje , Factores de Edad , Anciano , Femenino , Gastos en Salud , Planificación Hospitalaria , Hospitales , Hospitales de Alto Volumen , Hospitales de Bajo Volumen , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Países Bajos , Derivación y Consulta , Encuestas y Cuestionarios
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