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Pancreatic Fistula clinical trials

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NCT ID: NCT04985071 Completed - Bleeding Clinical Trials

Complication of Pancreatic Fistula and Bleeding After Pancreaticoduodenectomy in Treatment Periampullary Cancer

PF
Start date: August 1, 2021
Phase:
Study type: Observational [Patient Registry]

This multi-site study will be done across Hepatobiliary and Pancreatic Surgery Department at Cho Ray Hospital and University and Pharmacy Center. Patients who are diagnosed with periampullary cancer from August 2021 to August 2023 will be underwent pancreaticoduodenectomy. We will follow-up for their pancreatic fistula and bleeding complication and analysis some risk factors.

NCT ID: NCT04917172 Completed - Clinical trials for Postoperative Complications

Post-Operative Acute Pancreatitis After Pancreaticoduodenectomy

Start date: April 10, 2019
Phase:
Study type: Observational [Patient Registry]

The occurrence of post-pancreatectomy acute pancreatitis (PPAP) can critically impact outcomes after pancreaticoduodenectomy. Although diagnosing a PPAP can be challenging, its identification appears crucial as it can trigger additional morbidity. However, due to the early onset in the perioperative period, the actual spectrum of its early phases has not been systematically explored yet. For this reason, the present study will compare some early biochemical evidence of pancreatic stump damage to morphological changes evident at postoperative imaging. The postoperative evaluation of serum and/or urine pancreatic enzymes and the radiologic assessment are included in everyday clinical practice. However, the timing and the clinical relevance of such findings mostly rely on the single-institution experience. This study aims to characterize PPAP by investigating its early radiologic, biochemical, and clinical spectrum of either local or systemic changes associated.

NCT ID: NCT04898517 Completed - Pancreas Disease Clinical Trials

Prevention of CR-POPF in PD With the Technique of Connexion the Pancreatic Duct to Jejunum Stented (CONDUCTJE-ST).

CONDUCTJE-ST
Start date: January 1, 2018
Phase:
Study type: Observational

Objective: To assess the efficacy of the "connexion pancreatic duct to jejunum stented (CONDUCTJE-ST)" technique to prevent clinically relevant postoperative pancreatic fistula (CR-POPF) after pancreaticoduodenectomy (PD). Summary Background Data: CR-POPF remains the most determining cause of morbidity and mortality after PD. The incidence of CR-POPF (grades B and C, ISGPS) is around 20% and is a potential source of severe secondary complications that are associated with a mortality of up to 40%. Methods: A prospective pilot study included 50 consecutive patients who underwent PD with the CONDUCTJE-ST technique, the steps of which are described, performed by the same surgical team from January 2018 to February 2020. No patient received prophylactic or therapeutic somatostatin or its analogues. The primary endpoint was the incidence of CR-POPF. Secondary endpoints were postoperative mortality and morbidity, hospital course and during the first year of follow-up. In a prospective study we have evaluated a "novel" technique, modification of the preexisting ones, for the reconstruction of the digestive continuity of the corporocaudal remnant in the PD, termed "connexion pancreatic duct to jejunum stented (CONDUCTJE-ST)", applicable to any type of pancreatic remnant, regardless of its texture and the diameter of the main pancreatic duct. The study was planned with the objective of achieving a significant reduction in the incidence of CR-POPF, so that CONDUCTJE-ST could be considered as a surgical procedure of choice in the management of the pancreatic remnant in PD.

NCT ID: NCT04843670 Completed - Clinical trials for Pancreaticoduodenectomy

Isolated Pancreatic Loop With Modified Pancreaticojejunostomy

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

The aim of the present study was to observe whether the modified pancreatico- jejunostomy (PJ ) technique with an isolated pancreatic loop would effectively reduce the POPF rate and overall morbidity after PD

NCT ID: NCT04724551 Completed - Pancreas Neoplasm Clinical Trials

The Neutrophil-to-Lymphocyte Ratio to Exclude Pancreatic Fistula

NLR
Start date: June 1, 2012
Phase:
Study type: Observational

There is still no consensus on whether drain fluid amylase (DFA) level, C-reactive protein (CRP) level, or complex scores predict clinically relevant postoperative pancreatic fistula (CR-POPF). The aim of this study is to determine the accuracy of simple biochemical parameters (leucocytes, neutrophils, lymphocytes, Neutrophil to Lymphocytes Ratio (NLR), at postoperative days 1 and 3) to exclude the diagnosis of CR-POPF.

NCT ID: NCT04724174 Completed - Pancreatic Fistula Clinical Trials

Pancreaticogastrostomy for High-Risk Pancreas

GASTROPAN
Start date: June 1, 2013
Phase:
Study type: Observational

In 2013, a double purse-string telescoped pancreaticogastrostomy (PG) technique appeared to significantly reduce the risk of postoperative pancreatic fistula (POPF). This study compared the incidence of clinically relevant POPF in patients with high-risk anastomosis after undergoing PG or pancreaticojejunostomy (PJ) techniques.

NCT ID: NCT04609137 Completed - Pancreatic Fistula Clinical Trials

Early Drain Removal Versus Standard Drain Management After Distal Pancreatectomy (Early-Dist)

Early-Dist
Start date: October 13, 2020
Phase: N/A
Study type: Interventional

Main indications for distal pancreatectomy (DP) are pancreatic body and tail tumors including ductal adenocarcinoma, neuroendocrine tumors, and cystic neoplasms. Despite a less invasive operation with lower morbidity compared to pancreatic head surgery, DP is burdened by the occurrence of clinically-relevant postoperative pancreatic fistula (CR-POPF) in a significant proportion of patients. Drain fluid amylase (DFA) on POD 1 (postoperative day 1) > 2,000 U/L appears as the best performing threshold to predict the occurrence of CR-POPF after distal pancreatectomy. Although there is preliminary evidence that early drain removal in the subgroup of patients with DFA1 < 2,000 U/L may reduce POPF, no prospective study has yet evaluated the impact of an early drain removal strategy compared to standard management. The research question of this study is to evaluate to what extent early postoperative drain removal according to a validated DFA1 impact on clinically-relevant POPF rate after distal pancreatectomy in comparison to standard drain management. The primary hypothesis is that, early drain removal will result in a reduced proportion of patients experiencing grade B-C POPF according to ISGPS definition. The proposed study is a two-group, assessor-blind, randomized trial. Participants will be randomly assigned with a 1:1 ratio into one of two groups: (1) standard drain management or (2) early drain removal strategy. In this study adults (>18 years) patients with pancreatic body or tail diseases planned for distal pancreatectomy with or without splenectomy will be enrolled.The primary outcome is the POPF at 90 days after surgery, defined as grade B or C POPF according to ISGPS definition. Participants will be asked to complete some questionnaires in order to assess their general health status, and they will be evaluated at time of hospital admission, at 15 days, at 30 days after surgery (via telephone follow-up), and at 90 days after surgery (via telephone follow-up).

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: 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).