Post-operative Drainage After Pancreaticoduodenectomy

Not Applicable

Recruiting

• Conditions: Pancreatic Cancer
• Interventions: Procedure: Drain; Procedure: No drain

• Registration Number: NCT05270564
• Lead Sponsor: Linkoeping University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-01
• Status Verified: 2022-02
• Study First Submitted: 2022-02-16
• Study First Submitted QC: 2022-03-07
• Last Update Submitted: 2022-03-07
• Study First Posted: 2022-03-08
• Last Update Posted: 2022-03-08
• Primary Completion: 2024-12-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drain	Drain	Surgical drains used as routine
No drain	No drain	No surgical drain used

Primary Outcome Measures

Name	Time	Method
Overall morbidity rate	90 days post operatively	Post operative morbidity

Secondary Outcome Measures

Name	Time	Method
Need of interventional radiology	90 days post operatively
Mortality rate (in-hospital, 30 and 90 days)	90 days post operatively
Severe morbidity rate as classified by Clavien-Dindo >3	90 days post operatively
Fistula rate according to ISGPF	90 days post operatively
Intraabdominal abscess rate	90 days post operatively
Need for reoperation	90 days post operatively
Hospital stay	90 days post operatively
Readmission rate	90 days post operatively
Wound infection rate	90 days post operatively
Delayed gastric emptying according to ISGPF	90 days post operatively
Postpancreatectomy bleeding according to ISGPF	90 days post operatively

Trial Locations

Locations (2)

Linkoping University Hospital; 🇸🇪 Linköping, Sweden

Skanes University Hospital; 🇸🇪 Lund, Sweden