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Postoperative Pancreatic Fistula clinical trials

View clinical trials related to Postoperative Pancreatic Fistula.

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NCT ID: NCT06289530 Recruiting - Clinical trials for Postoperative Pancreatic Fistula

Association Between Perioperative Blood and Interstitial Fluid Glucose Level and Clinically Relevant Postoperative Pancreatic Fistula in Different Pancreatic Surgeries

CR-POPF
Start date: March 1, 2024
Phase:
Study type: Observational

This observational study was conducted in patients undergoing elective pancreaticoduodenectomy or distal pancreatectomy. It mainly answers the following two main questions: 1. What are the risk factors for clinically relevant postoperative pancreatic fistula in different pancreatic surgeries? 2. What is the correlation between perioperative blood and interstitial fluid glucose level and clinically relevant postoperative pancreatic fistula in different pancreatic surgeries? Participants were not required to perform additional research work other than the usual postoperative follow-up within 30 days after surgery. No control group was set in this study, and no additional clinical intervention was performed.

NCT ID: NCT06141044 Not yet recruiting - Drainage Clinical Trials

Prophylactic Abdominal Drainage vs no Drainage After Distal Pancreatectomy

PANDREAS
Start date: January 2024
Phase: N/A
Study type: Interventional

Postoperative pancreatic fistula (POPF) is a major source of morbidity and mortality after pancreatic resection, especially after distal pancreatectomy (PD). Today, POPF remains one of the main causes of hospital length of stay and healthcare costs. Numerous surgical techniques have been tested to reduce its incidence without success, so the current standard for the management of POPF, and the avoidance of associated complications, is intraoperative drain placement. However, surgically placed drains are not without risk. In recent years many studies, mostly retrospective, have attempted to determine whether omission of prophylactic drainage is associated with increased morbidity. These studies suggest that patients may benefit from not having a drain placed. This evidence challenges standard practice and the debate of whether or not to place a drain after distal pancreatectomy remains open. The investigators designed a prospective multicentre randomised non-inferiority study to determine whether prophylactic intraoperative drainage is associated with a lower morbidity rate after distal pancreatectomy.

NCT ID: NCT05843877 Not yet recruiting - Clinical trials for Periampullary Cancer

Pancreatic Head Resection or Total Pancreatectomy With Islet Autotransplantation in Patients With Periampullary Cancer and High Risk Profile for the Development of Postoperative Pancreatic Fistula

XandTX
Start date: June 2024
Phase: Phase 3
Study type: Interventional

The primary objective of this clinical trial is to evaluate whether primary total pancreatectomy with simultaneous islet autotransplantation compared with pancreatic head resection (alone) can reduce perioperative morbidity and time to initiation of adjuvant therapy in patients with a high-risk constellation for pancreatic fistulas.

NCT ID: NCT05789459 Completed - Clinical trials for Distal Pancreatectomy

Comparison of Outcomes With Stapler Versus Hand-Sewn Closure After Minimally Invasive Distal Pancreatectomy

Start date: July 1, 2018
Phase:
Study type: Observational

The incidence of postoperative pancreatic fistula (POPF) after Distal pancreatectomy (DP) remains high. Of the available mitigation strategies, high-quality closure of the pancreatic stump is fundamental. Researchers failed to find a decrease in the incidence of POPF after stapler closure of the pancreatic stump compared with that related to hand-sewn suture in DP. Minimally invasive DP (MDP) is becoming the first choice for patients and surgeons, few studies have evaluated whether stapler closure is superior to hand-sewn suture for stump closure in MDP. Therefore, this retrospective study was aimed at evaluating the effect of stapler versus hand-sewn closure on the incidence of POPF after MDP.

NCT ID: NCT05680623 Completed - Clinical trials for Postoperative Complications

Clinical and Economic Validation of the ISGPS Definition of PPAP

ISGPS-PPAP
Start date: January 1, 2022
Phase:
Study type: Observational

This prospective validation study aims to investigate the incidence of PPAP after pancreaticoduodenectomy (PD) by applying the ISGPS definition and grading system, to demonstrate its clinical impact by examining associated postoperative outcomes, and to validate its applicability through an economic assessment.

NCT ID: NCT05667272 Recruiting - Clinical trials for Postoperative Pancreatic Fistula

A Study on the Occurrence Time of Grade-B Pancreatic Fistula After Pancreatoduodenectomy

Start date: February 1, 2023
Phase:
Study type: Observational

To confirm the time point of CR-POPF of grade-B that patients with biochemical leak after PD or LPD turned into.

NCT ID: NCT05475275 Recruiting - Clinical trials for Pancreaticoduodenectomy

Different Pancreaticojejunostomy After Pancreaticoduodenectomy

Start date: February 1, 2022
Phase: N/A
Study type: Interventional

The aim of this study was to reduce the incidence of postoperative pancreatic fistula after pancreaticoduodenectomy by using different pancreaticojejunostomy methods according to the position of the pancreatic duct.

NCT ID: NCT04220931 Recruiting - Clinical trials for Distal Pancreatectomy

Intrapapillary Botulinum Toxin Injection for PREvention of Post-surgical PAncREactic Fistula

PREPARE
Start date: March 27, 2023
Phase: N/A
Study type: Interventional

Surgery is required for the treatment of many pancreatic conditions, either malignant or benign. Mortality of pancreatic surgery can be up to 3% even in expert centers. Morbidity is high, postoperative pancreatic fistula (POPF) being the main postoperative complication. In its current definition (drain output of any measurable fluid >= postoperative day 3 with amylase content >3 times the serum amylase activity and with clinical consequence), the incidence of postoperative PF is between 15 and 30 %. Most POPF resolve spontaneously but when refractory POPF occurs, it may lead to severe complications. POPF severity is graded as follows: grade B in case of change in medical management: infection without organ failure, specific medication (total parenteral nutrition, somatostatin analogs, antibiotics), persistent drainage > 3 weeks, angiographic procedure for bleeding, prolonged hospital stay; grade C in case of reoperation or PF-related organ failure or death. No specific prophylactic treatment of POPF is currently recommended by clinical guidelines. In clinical research, many prophylactic strategies have been attempted with partial efficacy. Endoscopic pancreatic sphincterotomy with plastic stent placement is effective in pre-and postoperative management of pancreatic fistula but with the need of a highly competent interventional endoscopist. Intrapapillary botulinum toxin injection is believed to induce relaxation of the pancreatic sphincter, leading to a " pharmacological " pancreatic sphincterotomy without any morbidity. A recent phase I/II prospective study has shown promising results in this indication, with no clinically relevant pancreatic fistula when botulinum toxin was injected. Based on this observation we hypothesize that intrapapillary botulinum toxin injection during an endoscopic procedure before surgery could be effective for the prevention of post-surgical pancreatic fistula

NCT ID: NCT04058236 Recruiting - Pancreatic Cancer Clinical Trials

Glycocalyx Levels in Patients Undergoing Pancreatectomy

Start date: August 15, 2019
Phase: Phase 4
Study type: Interventional

Background: On the surface of every healthy cellular membrane resides a layer known as the glycocalyx. This structure consists of extracellular domains of receptor, adhesion and transmembrane molecules such as syndecan-1 covalently bound to highly negatively charged glycosaminoglycans, heparan sulfates. It has a principal role to maintain wall integrity, avoid inflammation and tissue oedema in vessels but in contrast, glycocalyx is robust and elevated on cancer cells. This study examines whether the endothelial glycocalyx layer is preserved in patients undergoing pancreatectomy with human albumin 5% vs. gelofusine in a restrictive goal directed fluid regime perioperatively for the first 24hours. Degradation of glycocalyx will be investigated by analyzing basic levels of the core protein syndecan-1 and heparan sulfates with post-operative samples.

NCT ID: NCT01481753 Terminated - Clinical trials for Delayed Gastric Emptying

Pancreaticoduodenectomy With or Without Braun Enteroenterostomy: Comparison of Postoperative Pancreatic Fistula and Delayed Gastric Emptying

Start date: December 2009
Phase: N/A
Study type: Interventional

The investigators plan to perform a prospective randomized, head-to-head trial to test the hypothesis that the addition of Braun enteroenterostomy to standard pancreaticoduodenectomy (PD) reconstruction can decrease the rates of Postoperative Pancreatic Fistula (POPF) and/or Delayed Gastric Emptying (DGE).