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Pancreatic Fistula clinical trials

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NCT ID: NCT06198400 Not yet recruiting - Pancreatic Fistula Clinical Trials

Indocyanine Green Fluorescence in Evaluation of Pancreatic Remnant Perfusion.

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Main goal of this study is to evaluate the blood flow in a post resection pancreatic remnant after pancreaticoduodenectomy with use of indocyanine green fluorescence. If the hypothesis will be proven, evaluation of perfusion of the pancreatic remnant with indocyanine green could be used to estimate the increased risk of the development of pancreatic fistula.

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: NCT05992857 Not yet recruiting - Clinical trials for Complication of Surgical Procedure

Pancreaticoduodenectomies With Complete Arterial Coverage by Retromesenteric Omentoplasty

PACOMARCO
Start date: February 2024
Phase: N/A
Study type: Interventional

To assess the efficacy of complete covering using retromesenteric omentoplasty vs. partial covering or no covering of peripancreatic arteries in decreasing incidence of grade B+C post-pancreatectomy hemorrhage (PPH), i.e. treated by transfusion and / or radiological or surgical hemostasis after PD in patients with high risk of POPF.

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: 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: 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: 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.

NCT ID: NCT04900012 Not yet recruiting - Clinical trials for Surgery--Complications

Prospective Snapshot Audit of Distal Pancreatectomy in Spain

Spadispan
Start date: July 1, 2021
Phase:
Study type: Observational

Distal pancreatectomy is the surgical technique performed to treat many pancreatic diseases located in neck and tail of the pancreas. Laparoscopic approach is the gold standard but in many centres the percentage of laparoscopic approach is still low. This technique has low mortality but 30% morbidity mostly related to pancreatic fistula. Some new devices (linear stapler, energy devices and patches) seem to decrease pancreatic fistula but there is not evidence based medicine that confirm the results published usually in unicentric studies.

NCT ID: NCT04582461 Not yet recruiting - Pancreatic Fistula Clinical Trials

Role of Preoperative Multislice Computed Tomography in Whipple's Operation.

Start date: January 1, 2021
Phase:
Study type: Observational

Preoperative assessment of visceral fat volume(VFV),total fat volume(TFV),pancreas/spleen density ratio and pancreatic duct diameter by multislice computed tomography abdomen to predict the risk of pancreatic fistula after Whipple's operation.

NCT ID: NCT03752086 Not yet recruiting - Clinical trials for Pancreatic Neoplasms

Greater Omentum Binding to the Pancreatic Stump to Prevent Pancreatic Fistula Following Distal Pancreatectomy

Start date: January 2019
Phase: N/A
Study type: Interventional

Background and aim: Distal pancreatectomy (DP) is often performed for primary benign or malignant lesions occurred in the body or tail of the pancreas. The occurrence of pancreatic fistula (PF) after DP remains high, ranging from 5% to 60%, despite in high-volume centers. Management of pancreatic stump to prevent PF has been a long-standing issue in pancreatic surgery. Our group has proposed greater omentum binding as a novel approach to secure pancreatic stump with the purpose of reducing PF. With respect to the previous preliminary data which demonstrated greater omentum binding of pancreatic stump significantly reduced the occurrence of PF based on a small prospective cohort, we therefore aimed to verify the safety and effectiveness of this novel approach in a large prospective randomized cohort. Method: TJBDPS06 is a prospective, randomized controlled, parallel-group, superiority trial in a single high-volume pancreatic center. A total of 200 patients who will receive DP and fulfill the inclusion criteria will be randomly allocated to the greater omentum binding group or the group without this step in an enhanced recovery after surgery (ERAS) setting. The trial hypothesize that greater omentum binding of pancreatic stump could safely and effectively secure pancreatic stump following DP, therefore reducing the occurrence of PF. The primary outcome is PF within 90 days after DP. The secondary outcomes are overall morbidly, mortality, and major complications (Clavien-Dindo ≥III) within 90 days following DP. The duration of entire trial is presumably three years, including prearrangement, two-year inclusion period, and data analysis. Discussion: The current trial will be the first in demonstrating safety and effectiveness of greater omentum binding of pancreatic stump following DP in a large high-volume pancreatic center. This approach will offer an inexpensive, technically easy, and secure coverage technique for the pancreatic stump in DP and may be particularly useful for patients with a soft pancreas which is a markedly risk factor of PF.