Post-operative Drainage After Pancreaticoduodenectomy

Pancreatic Cancer Clinical Trial

— Drain 1  

Official title:

Post-operative Drainage After Pancreaticoduodenectomy: A Randomized Controlled Trial of Patients With Intermediate and Low Risk for Pancreatic Fistula

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05270564
• Other study ID #: Drain_1
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2016
• Est. completion date: March 31, 2025

Study information

• Verified date: February 2022
• Source: Linkoeping University
• Contact: Bergthor Björnsson
• Phone: +46703766890
• Email: bergthor.bjornsson[@]liu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study compares regular use of surgical drains and no use of surgical drains in patients subjected to pancreaticoduodenectomy with expected low to intermediate risk for post operative pancreatic fistula.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing pancreaticoduodenectomy of both sexes

• Patients with predicted risk score of 10 or less of pancreatic fistula

• Written informed consent

• Expected survival time > 6 months

Exclusion Criteria:

• Patients with predicted high risk of fistula with a risk score above 10

• Patients with intraabdominal abscess or infection

• ASA score > 3

• Pregnancy

• Expected lack of compliance

Related Conditions & MeSH terms

• Pancreatic Cancer

Intervention

Procedure:
• Drain
Surgical drains are placed as a standard of care (control arm) or not (experimental arm)
• No drain
Surgical drains are placed as a standard of care (control arm) or not (experimental arm)

Locations

Country	Name	City	State
Sweden	Linkoping University Hospital	Linköping
Sweden	Skanes University Hospital	Lund

Sponsors (2)

Lead Sponsor	Collaborator
Linkoeping University	Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall morbidity rate	Post operative morbidity	90 days post operatively
Secondary	Mortality rate (in-hospital, 30 and 90 days)		90 days post operatively
Secondary	Severe morbidity rate as classified by Clavien-Dindo >3		90 days post operatively
Secondary	Fistula rate according to ISGPF		90 days post operatively
Secondary	Intraabdominal abscess rate		90 days post operatively
Secondary	Wound infection rate		90 days post operatively
Secondary	Delayed gastric emptying according to ISGPF		90 days post operatively
Secondary	Postpancreatectomy bleeding according to ISGPF		90 days post operatively
Secondary	Need of interventional radiology		90 days post operatively
Secondary	Need for reoperation		90 days post operatively
Secondary	Hospital stay		90 days post operatively
Secondary	Readmission rate		90 days post operatively