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2016-05-01
2024-12-31
2025-03-31
300
NCT05270564
Linkoeping University
Linkoeping University
INTERVENTIONAL
Post-operative Drainage After Pancreaticoduodenectomy
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-02-16 | N/A | 2022-03-07 |
2022-03-07 | N/A | 2022-03-08 |
2022-03-08 | N/A | 2022-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: Drain Surgical drains used as routine | PROCEDURE: Drain
PROCEDURE: No drain
|
| EXPERIMENTAL: No drain No surgical drain used | PROCEDURE: No drain
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall morbidity rate | Post operative morbidity | 90 days post operatively |
| Secondary Outcome Measures | Measure Description | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Bergthor Björnsson Phone Number: +46703766890 Email: bergthor.bjornsson@liu.se |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
