NCT05017207

Clinically Relevant Pancreatic Fistula After Pancreaticoduodenectomy

Clinically Relevant Postoperative Pancreatic Fistula After Pancreaticoduodenectomy for Periampullary Cancer and Risk Factors: A Prospective Multicenter Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 183 (actual)
• Sponsor: Vo Truong Quoc · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

Summary

Patients who are diagnosed with periampullary cancer will be performed pancreaticoduodenectomy with 3 types of pancreatic-jejunal anastomosis reconstructions. The investigator will analysis the complication of pancreatic fistula about: the clinical symptoms, laboratory test changing, intra-operative morphology, the risk factors

Detailed description

This study will conduct at two centers at the same time: University of Medicine and Pharmacy Center and Cho Ray Hospital. The patients will be consulted to participate to this research from September, 2021 to April, 2023. Plan for conducting study: * The investigator consults and gets consensus form of the patient with periampullary cancer. * The patient will be prepared for pancreaticoduodenectomy: pre-operative laboratory test, pre-operative biliary drainage, anesthetic checking. * The investigator collected intr-operative data, include type of pancreatic-duodenal reconstruction, type of pancreatic duct's drainage, quantity of blood loss and blood transfusion. * The investor follows post-operative period. * If there are pancreatic fistula appear, the investigator will collect the clinical signs, laboratory test changing, re-operative morphology. * The investigator analysis the risk factors of pancreatic fistula. Data analysis: * To determine the incidence of pancreatic fistula, the morphology of pancreatic fistula, descriptive statistics will be used. * To determine the risk factors of pancreatic fistula, logistic regression will be used. Sample size: * The investigator plans to collect 145 patients in the research period. Plan for missing data: * Any case that miss information will be removed from the study.

Conditions

• Pancreatic Fistula

Interventions

Type	Name	Description
PROCEDURE	Pancreaticoduodenectomy	Pancreaticoduodenectomy with one of 2 types of pancreaticojejunal anastomosis: Blumgart and conventional duct-to-mucosa

Timeline

• Start date: 2021-08-01
• Primary completion: 2023-10-31
• Completion: 2023-10-31
• First posted: 2021-08-23
• Last updated: 2024-05-17

Locations

1 site across 1 country: Vietnam