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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05017207
• Other study ID #: Trquoc
• Status: Completed
• Start date: August 1, 2021
• Est. completion date: October 31, 2023

Study information

• Verified date: May 2024
• Source: University of Medicine and Pharmacy at Ho Chi Minh City
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fistula
• Pancreatic Fistula

Intervention

Procedure:
• Pancreaticoduodenectomy
Pancreaticoduodenectomy with one of 2 types of pancreaticojejunal anastomosis: Blumgart and conventional duct-to-mucosa

Locations

Country	Name	City	State
Vietnam	University Medical Center of HCMC	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
Vo Truong Quoc

Country where clinical trial is conducted

Vietnam, 

References & Publications (1)

Kawaida H, Kono H, Hosomura N, Amemiya H, Itakura J, Fujii H, Ichikawa D. Surgical techniques and postoperative management to prevent postoperative pancreatic fistula after pancreatic surgery. World J Gastroenterol. 2019 Jul 28;25(28):3722-3737. doi: 10.3748/wjg.v25.i28.3722. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pancreatic fistula	The investigator will describe the day that appears pancreatic fistula, the clinical symptoms, intra-operative morphology if being indicated to re-operate. The measurement tool to diagnose pancreatic fistula is fluid amylase on the POD3 (fluid amylse is 3 times compared to serum's amylase)	30 days of post-operative period
Primary	Risk factors relate to pancreatic fistula	The investigator will analyse some of the risk factors that relate to pancreatic fistula, including pre-operative factors (BMI, albumin, bilirubin, biliary drainage), intra-operative elements (pancreatic duct 's diameter, pancreatic textile, blood transfusion, portal vein reconstruction), and post-operative factors (abdominal drainage's volume, fluid amylase, abdominal abscess..). The investigator will use the multivariable regression model to determine the risk factors (p-value<0.05)	30 days of post-operative period
Secondary	Short-term result in treatment of post-operative pancreatic fistula	The investigator will describe the result of pancreatic fistula treatment: intra-operative morphology, re-operative success ratio, morbidities.	30 days of post-operatvive period

External Links

•   Surgical techniques and postoperative management to prevent postoperative pancreatic fistula after pancreatic surgery