Post-operative Drainage After Pancreaticoduodenectomy
Drain 1
1 other identifier
interventional
300
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pancreatic-cancer
Started May 2016
Longer than P75 for not_applicable pancreatic-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 16, 2022
CompletedFirst Posted
Study publicly available on registry
March 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2025
CompletedMarch 8, 2022
February 1, 2022
8.7 years
February 16, 2022
March 7, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Overall morbidity rate
Post operative morbidity
90 days post operatively
Secondary Outcomes (11)
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
- +6 more secondary outcomes
Study Arms (2)
Drain
ACTIVE COMPARATORSurgical drains used as routine
No drain
EXPERIMENTALNo surgical drain used
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Linkoeping Universitylead
- Lund Universitycollaborator
Study Sites (2)
Linkoping University Hospital
Linköping, 582 72, Sweden
Skanes University Hospital
Lund, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bergthor Björnsson
Linkoeping University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 16, 2022
First Posted
March 8, 2022
Study Start
May 1, 2016
Primary Completion
December 31, 2024
Study Completion
March 31, 2025
Last Updated
March 8, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share