Post-operative Drainage After Pancreaticoduodenectomy (Drain 1)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Procedure: Drain; Procedure: No drain

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Linköping, Sweden, 582 72
    • Recruiting
    • Linkoping University Hospital
  • Lund, Sweden
    • Recruiting
    • Skånes University Hospital
    • Contact: Bobby Tingstedt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Drain; Surgical drains used as routine	Procedure: Drain; Surgical drains are placed as a standard of care (control arm) or not (experimental arm)
EXPERIMENTAL: No drain; No surgical drain used	Procedure: No drain; Surgical drains are placed as a standard of care (control arm) or not (experimental arm)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall morbidity rate	Post operative morbidity	90 days post operatively

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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
Need of interventional radiology	90 days post operatively
Need for reoperation	90 days post operatively
Hospital stay	90 days post operatively
Readmission rate	90 days post operatively

Collaborators and Investigators

• Sponsor: Linkoeping University
• Collaborators: Lund University
• Investigators: Principal Investigator: Bergthor Björnsson, Linköping University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2016
• Primary Completion (ANTICIPATED): December 31, 2024
• Study Completion (ANTICIPATED): March 31, 2025

Study Registration Dates

• First Submitted: February 16, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (ACTUAL): March 8, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 8, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Drain_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No