Clinically Relevant Pancreatic Fistula After Pancreaticoduodenectomy

Pancreatic Fistula Clinical Trial

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

Status Completed

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Fistula
• Pancreatic Fistula

• NCT number: NCT05017207
• Study type: Observational [Patient Registry]
• Source: University of Medicine and Pharmacy at Ho Chi Minh City
• Status: Completed
• Start date: August 1, 2021
• Completion date: October 31, 2023