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Pancreatic Fistula clinical trials

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NCT ID: NCT05668260 Recruiting - Clinical trials for Pancreatoduodenectomy

Internal Biodegradable Stent Versus Non-Stent in Patients at High-Risk of Developing Fistula After Pancreatoduodenectomy

BioSteP
Start date: January 25, 2023
Phase: N/A
Study type: Interventional

The aim of this randomized controlled study is to compare the efficacy of biodegradable internal pancreatic stenting versus no stenting in patients undergoing pancreatoduodenectomy (PD), focusing on a possible superiority association of the device in preventing clinically relevant postoperative pancreatic fistula (CR-POPF). Patients undergoing PD will be randomized into two arms: - arm 1: a biodegradable internal pancreatic stent will be placed at the level of the pancreatic anastomosis - arm 2: no pancreatic stent will be placed at the level of the pancreatic anastomosis The rate of occurrence of CR-POPF will be compared between the two arms.

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: NCT05657366 Not yet recruiting - Pancreatic Fistula Clinical Trials

Peritoneal Lavage on the Incidence of Pancreatic Fistula and Related Complications After Pancreatoduodenectomy

Start date: May 1, 2023
Phase: N/A
Study type: Interventional

As one of the possible strategies to prevent pancreatic fistula, peritoneal lavage is still widely used in clinical practice, but it lacks more evidence of evidence-based medicine and recommendations of guidelines. Some clinicians believe that routine flushing after pancreatoduodenectomy wastes medical resources and has a negative impact on patients' comfort. In this study, the investigators designed a multicenter prospective controlled trial to compare the effects of peritoneal lavage and natural drainage on the incidence of pancreatic fistula and related complications after pancreatoduodenectomy. To study the indications of peritoneal lavage.

NCT ID: NCT05657327 Active, not recruiting - Pancreatic Fistula Clinical Trials

Application and Optimization of the International Study Group of Pancreatic Surgery (ISGPS) Definition and Grading Criteria for Postoperative Complications of Pancreatic Surgery in Laparoscopic Pancreatic Surgery

Start date: January 1, 2014
Phase:
Study type: Observational

In recent years, with the continuous development of minimally invasive techniques, laparoscopic pancreatic surgery has also been widely used. Although the postoperative mortality rate of laparoscopic pancreatic surgery has been decreasing as the technology continues to improve and mature, the complication rate reported varies widely among centers.The definition and grading criteria of ISGPS on postoperative complications of pancreatic surgery are mostly proposed based on open pancreatic surgery, and most of the data of the later related studies are also for open pancreatic surgery, while the applicability of the definition and grading criteria in laparoscopic pancreatic surgery is still lacking in systematic The study The main purpose of this study is to investigate the applicability of the ISGPS definition and grading criteria for pancreatic fistula, postoperative bleeding and delayed gastric emptying in laparoscopic pancreatic surgery.

NCT ID: NCT05654636 Not yet recruiting - Clinical trials for Risk Scoring System for Prediction of Pancreatic Fistula Post PD

Evaluation of Sun's Scoring System Use in Post-pancraticodoudenectomy Pancreatic Fistula

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

Evaluation of sun scoring system for predication of pancreatic fistula after Pancreaticoduodenectomy to facilitate timely intervention after Pancreaticoduodenectomy.

NCT ID: NCT05641233 Recruiting - Pancreatic Fistula Clinical Trials

Preoperative Radiotherapy in Patients at High Risk of Postoperative Pancreatic Fistula After Pancreatoduodenectomy

FIBROPANC-1
Start date: December 1, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The FIBROPANC-1 investigates the feasibility and safety of preoperative stereotactic radiotherapy of 4cm pancreas in patients undergoing pancreatoduodenectomy at high risk (>25%) of developing post operative pancreatic fistula (POPF). A single course of 12Gy preoperative radiotherapy may lead to sufficient fibrosis in a small (4cm) targeted area, thereby reducing the risk of grade B and C POPF.

NCT ID: NCT05518643 Recruiting - Pancreas Cancer Clinical Trials

Compliance With ERAS Protocol in Pancreatic Surgery, Stress Response and Outcomes

Start date: July 15, 2022
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to evaluate the impact of compliance with enhanced recovery after surgery (ERAS) program on patient reported outcomes (PROs), surgery-specific outcomes and stress response after pancreatic surgery. This prospective observational study will include all consecutive patients undergoing pancreatic surgery over a period of three years (2022 - 2025) at two sites, namely University General Hospital of Larissa and IASO Thessalias, in Greece. Patients will be prospectively enrolled after written informed consent. Data will be collected on patient characteristics, surgical and anaesthetic techniques, complications, and length of stay. Quality of life questionnaires will be administered to patients preoperatively, on the fith postoperative day, first follow-up after discharge, one month and six months after the operation. The stress response will be assessed by measuring the Neutrophil-Lymphocyte Ratio and Platelet-Lymphocyte Ratio (NLR and PLR) preoperatively, and on the first five postoperative days. Data will be collected on pancreatic surgery-specific complications such as delayed gastric emptying (DGE), post-pancreatectomy haemorrhage (PPH) and postoperative pancreatic fistula (POPF) formation. Anonymised data will be uploaded by the principal investigator on a protected excel spreadsheet for analysis.

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: NCT05404256 Recruiting - Pancreatic Fistula Clinical Trials

Comparison of Effectiveness of TissuePatchTM in Preventing Postoperative Pancreatic Fistula

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

Postoperative pancreatic fistula is one of the most serious complications after gastric cancer surgery and can lead to surgery-related death. Postoperative pancreatic fistula for gastric cancer often occurs in accidental injury of pancreas during peripancreatic lymph node dissection, blunt separation of pancreatic capsule injury, laparoscopic instrument clamp and long-term compression of pancreas, etc. TissePatchTM is a synthetic, self-adhesive, absorbable surgical sealant and barrier used to seal and reinforce wounds and prevent leakage of air, blood, and fluid during neurosurgery, spine, chest, and soft tissue surgery. Therefore, we proposed whether the use of TissuePatchTM can reduce the occurrence of pancreatic fistula after gastric cancer surgery, and the clinical trial of the effectiveness of TissuePatchTM on the prevention of pancreatic fistula after radical gastrectomy of gastric cancer can provide new clinical data for the prevention of pancreatic fistula after gastric cancer surgery, and help reduce a series of adverse reactions caused by pancreatic fistula in patients.

NCT ID: NCT05387538 Not yet recruiting - Pancreatic Fistula Clinical Trials

One-layer Versus Two-layer Duct-to-mucosa Pancreaticojejunostomy After Pancreaticoduodenectomy .

Start date: May 30, 2022
Phase: N/A
Study type: Interventional

Postoperative pancreatic fistula (POPF) is one of the most frequent and ominous complications after PD, and its occurrence reportedly ranges from 2-40 %. Severe POPF prolongs hospital stay and requires the use of specific treatments, such as the use of antibiotics, nutritional support, endoscopy, interventional radiology, and/or reoperation, etc.. Several anastomotic surgical techniques have been developed to reduce the incidence of pancreatic fistula in recent decades, including the duct-to-mucosa method, pancreaticogastrostomy, Peng's binding method, and the "end-to-end" or "end-to-side" invaginated method. Among these techniques, the conventional duct-to-mucosa method remains the most popular anastomosis due to its advantages. The size of the pancreatic remnant is not limited; moreover, the jejunal lumen and pancreatic remnant lead to easier anastomosis . Compared with two-layer duct-to-mucosa anastomosis, the novel one-layer duct-to-mucosa PJ anastomosis method has been reported to be efficient at reducing POPF occurrence. However, the two cited retrospective studies might lead to selection bias. Because this evidence is insufficient, we will conduct a randomized controlled trial to verify the superiority of one-layer duct-to-mucosa PJ anastomosis after PD over the two-layer technique.