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Pancreatic Fistula clinical trials

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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: NCT04514198 Completed - Pancreas Disease Clinical Trials

Postoperative Pancreatitis and Its Correlation With Clinically Relevant Pancreatic Fistula in Pancreaticoduodenectomy

Start date: March 1, 2020
Phase:
Study type: Observational

AIM To determine association between postoperative pancreatitis and pancreatic fistula OBJECTIVES 1. To determine incidence of Clinically relevant pancreatic fistula (grade B/C) after pancreaticoduodenectomy 2. To determine role of serum amylase levels on day 1 to predict clinically relevant pancreatic fistula 3. To determine risk factors for postoperative pancreatitis and postoperative pancreatic fistula Primaryendpoint: Incidence of post operative pancreatitis and post operative pancreatic fistula. Secondaryendpoints: 1. to identify the possible predictors of post operative pancreatitis. 2. to investigate the association between post operative pancreatitis and post operative pancreatic fistula. MATERIAL AND METHODS Study centre: Inpatient admissions in Department of gastroenterology, Asian institute of gastroenterology, Hyderabad Study population: Patients who are supposed to undergo pancreaticoduodenectomy Study design: Prospective observational study Study period: Study will be conducted till desired sample size achieved or March 2020 to march 2022

NCT ID: NCT04448795 Completed - Pancreas; Fistula Clinical Trials

Impact of Highest Drain Fluid Amylase Levels on Surgical Outcomes and Postoperative Interventions in Patients Undergoing Pancreaticoduodenectomy

Start date: October 1, 2010
Phase:
Study type: Observational

This study investigated the impact of highest drain fluid amylase (DFA) level on postoperative pancreatic fistula (POPF) severity and outcomes of patients undergoing pancreaticoduodenectomy (PD) with POPF. Patient demographics of biochemical POPF and clinically relevant POPF (CR-POPF) were compared. Predictive factors were assessed using binary logistic regression. Receiver operating characteristic curve analysis was performed to determine the optimal cutoff value of highest DFA (beyond 3 days post-PD). The investigators compared length of hospital stay, surgical mortality rates, and need for postoperative interventions by highest DFA level.

NCT ID: NCT04418739 Recruiting - Pancreatic Cancer Clinical Trials

Intravenous Human Albumin In Improving Pancreaticoduodenectomy Outcomes

Start date: January 27, 2020
Phase: Phase 2
Study type: Interventional

Pancreaticoduodenectomy (PD), more commonly known as Whipple's surgery is the mainstay treatment for pancreatic head and periampullary cancer. Factors contributing to PD outcomes are broadly categorized to disease-related, patient-related and operative factors. Whereas an inexhaustible list of study exists on looking at reducing PD complication rates with respect to the above-mentioned factors, it was only recently that more attention has been given to the impact of perioperative and intraoperative fluid regimes on PD outcomes. This study takes interest in the impact of intraoperative fluid regimes on PD outcomes. The objective of this investigation is to compare the outcomes with the use of intraoperative intravenous human albumin versus standard intraoperative fluid regimes.

NCT ID: NCT04402346 Recruiting - Pancreas; Fistula Clinical Trials

Radiofrequency-assisted Transection of the Pancreas vs Stapler

TRANSPAIRE
Start date: February 15, 2021
Phase: N/A
Study type: Interventional

Main objective: The main end-point of this study is to compare in a randomized clinical trial that radiofrequency-assisted pancreas transection (RF) reduces the incidence of postoperative pancreatic fistula (POPF) compared to the classical method of transection (stapler). As secondary end-points, other clinical and demographic variables of the patients will be evaluated (sex, age, ASA classification, consistency of the pancreas, as well as the type of procedure, open or laparoscopic surgery, estimated intraoperative bleeding, pancreatic duct size, duration of intervention, type of tumor and quality of lymphatic resection). Methodology: Phase III prospective multicenter study in patients undergoing distal pancreatectomy for any origin. All consecutive patients who undergo a distal pancreatectomy for any cause in a multicenter setting will be included. A simple randomization of the participants to the RFA group or to the control group (stapler) will be carried out. The incidence of pancreatic fistula will be assessed as main variable; predictive multivariable models with multiple regression for quantitative variables, logistic regression for categorical variables and Cox regression for survival analyzes. In addition to histological study, molecular analysis of resection specimen and clinical and radiological follow-up with volumetry of necrosis in the area of post-pancreatectomy transection will be performed.

NCT ID: NCT04380506 Recruiting - Pancreas Cancer Clinical Trials

Validations of New cut-of for the Stratification of Postoperative Complications,Drains Management

DALCUT
Start date: March 15, 2020
Phase: N/A
Study type: Interventional

Pancreatic fistula (PF) represents the Achille's heel of pancreatic surgery and is the main cause of postoperative morbidity since it can determine the onset of others complications such as abdominal abscesses, surgical wound infections, sepsis and bleeding, that can sometimes be fatal. During a previous study conducted at the University Campus Bio-Medico of Rome, Department of General Surgery there were identified cut-offs of amylase levels on the abdominal drainage fluid dosed in I postoperative day (POD1) and III postoperative day (POD3) which can significantly predict PF and in particular clinically relevant fistulas as well as abdominal collections and biliary fistulas, if related to some specific findings of the abdominal CT routine performed in POD3. The aim of this research project is to validate the cut-offs of the amylase levels on drainage fluid identified during the previous research in order to identify patients at risk of clinically relevant PF and to validate the use of abdomen CT without contrast in POD3 in patients with increased risk of biliary fistula.

NCT ID: NCT04361682 Completed - Pancreas Cancer Clinical Trials

Preoperative Inflammatory Biomarkers and Postoperative Day 1 Drain Amylase Value Predict Pancreatic Fistula After Pancreaticoduodenectomy

Start date: January 1, 2005
Phase:
Study type: Observational

Particularly, pancreatic fistula is the most common and serious complication after pancreaticoduodenectomy (PD) and is reported in up to 40% of cases. The aim of this retrospective single-center study was to investigate the utility of the combination of preoperative inflammation biomarkers (PIBs) with postoperative day 1 drains amylase (POD1-d.a.) levels in predicting grade C Pancreatic Fistula (PF).

NCT ID: NCT04357483 Recruiting - Pancreatic Tumor Clinical Trials

Effect of Thrombin-containing Collagen-based Hemostatic Matrix

TCM
Start date: February 1, 2018
Phase: Phase 4
Study type: Interventional

Under the hypothesis that collagen-based hemostatic agents improve the suppression of leakage of hemostatic pancreatic fluid at the surgical site during surgery, thrombin-containing collagen-based hemostatic agents are applied in surgery in patients with pancreatectomy. The investigators intend to evaluate the effectiveness of collagen-based hemostatic agents containing thrombin through clinical evaluation of hemostatic effect and anti-leakage effect of pancreatic fluid. This clinical study is a study for comparative evaluation of hemostasis and anti-leakage effect of bile or pancreatic fluid when applied after pancreatic resection of a collagen-based hemostatic agent containing thrombin. It is prospective, single center, randomized, and non-inferiority test. Participants are patients who are diagnosed with pancreatic disease and other diseases, and plan to undergo pancreatectomy. Through the randomization, in the case of the intervention group, after the pancreatectomy, the Collastat (CollaStat®, Dalim Tissen. Co., Ltd., Korea) is applied to the cut surface, and in the case of the control group, Collaseal (CollaSeal®, Dalim Tissen. Co., Ltd., Korea) is applied. In this study, 30 participants were required for each intervention group and control group. After surgery, the participants is hospitalized for 7 days and undergoes follow-up observation. Pancreatic leakage is measured through the drainage tube before discharge and evaluated as biochemical leakage (BL), B, or C according to the definition of International Study Group for Pancreatic Fistula (ISGPS). The primary endpoint of this study was the prevention rate of leakage. The postoperative pancreatic fistula (POPF) was defined according to the definition of ISGPS. Secondary end point was assessed as the difference between groups of total number of collagen hemostatic agents used, hospital length of stay and number of patient who received RBC transfusion. Safety was assessed based on the incidence of adverse events occurred.

NCT ID: NCT04348084 Completed - Clinical trials for PDAC of the Body and the Tail of the Pancreas

Oncologic Impact of Pancreatic Fistula

POPF-DSS
Start date: January 30, 2009
Phase:
Study type: Observational

Clinically-relevant post-operative fistula is a major complication after DP, but it did not affect post-operative therapeutic path nor oncologic long-term outcomes. CR-POPF was not a predictive factor for disease recurrence and it was not associated with an increased incidence of peritoneal or local relapse.

NCT ID: NCT04281680 Completed - Clinical trials for Surgical Complications

Impact of Pasireotide on Postoperative Pancreatic Fistulas Following Distal Resections

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

Between 2000 and 2016 258 distal pancreatectomies were performed at our University Hospital which were included in our analysis. Pasireotide was used in between July 2014 and April 2016. Patients received 900-ug pasireotide administered twice daily perioperatively. We analyzed patients who received octreotide treatment separately. Complications such as fistulas (POPF), delayed gas-tric emptying (DGE), postoperative hemorrhage (PPH), reoperations and mortality were recorded and analyzed 90 days postoperatively