Clinically Relevant Pancreatic Fistula After Pancreaticoduodenectomy

Vo Truong Quoc

Status: Completed

Conditions: Pancreatic Fistula

Treatments: Procedure: Pancreaticoduodenectomy

Study type: Observational

Funder types: Other

Identifiers

NCT05017207

Trquoc

Details and patient eligibility

About

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

Full 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.

Enrollment: 183 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with periampullary cancer and can be performed pancreaticoduodenectomy.
• Pancreaticoduodenectomy with one of three types of pancreatic - duodenal anastomosis reconstructions.

Exclusion criteria

• The patient does not consent to participate in the study

Trial design

183 participants in 1 patient group

Patient with periampullary cancer and pancreaticoduodenectomy

Description:

Only one group of patient with periampullary cancer

Treatment:

Procedure: Pancreaticoduodenectomy