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2018-11-01
2018-12-01
2021-05-01
60
NCT04783831
Hospital Universitario Virgen de la Arrixaca
Hospital Universitario Virgen de la Arrixaca
OBSERVATIONAL
Biodegradable Pancreatic Stents for the Prevention of Postoperative Pancreatic Fistula After Cephalic Pancreaticoduodenectomy
Background: postoperative pancreatic fistula (POPF) remains the most important morbidity after pancreaticoduodenectomy (PD). There is no consensual technique for pancreatic reconstruction and many surgeons use a transanastomotic drain. Currently, the stents used are not degradable and they can cause obstruction, stricture and pancreatitis. The use of biodegradable stents that disappear a few months after the intervention could have a role in the prevention of pancreaticojejunostomy complications. Material and method: A single-center prospective randomized study was planned with patients undergoing PD. A duct-to-mucosa end-to-side anastomosis is performed for the pancreaticojejunal anastomosis and the stent is placed from the pancreatic duct to the jejunum. The primary outcome of the study is the evaluation of the presence of POPF (drainage fluid amylase value of > 5000 U/L on the first day).
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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 |
|---|---|---|
2021-03-02 | N/A | 2021-03-07 |
2021-03-04 | N/A | 2021-03-09 |
2021-03-05 | N/A | 2021-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
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Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Biodegradable stent | DEVICE: Biodegradable stent
|
| : Non-biodegradable stent | DEVICE: Biodegradable stent
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| POPF | Evaluation of the presence of POPF (drainage fluid amylase value of > 5000 U/L on the first day). | 1 week |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Position and degradation of biodegradable stents | Evaluation of the position and degradation time of the biodegradable stents | 3 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
