Biodegradable Pancreatic Stents for the Prevention of Postoperative Pancreatic Fistula After Cephalic Pancreaticoduodenectomy
Usefulness of Biodegradable Pancreatic Stents for the Prevention of Postoperative Pancreatic Fistula After Cephalic Pancreaticoduodenectomy. Prospective Non-randomized Controlled Clinical Study Comparing Biodegradable vs Non-biodegradable Stents
1 other identifier
observational
60
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2018
Typical duration for all trials
1 active site
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
November 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedFirst Submitted
Initial submission to the registry
March 2, 2021
CompletedFirst Posted
Study publicly available on registry
March 5, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedMarch 9, 2021
March 1, 2021
1 month
March 2, 2021
March 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
POPF
Evaluation of the presence of POPF (drainage fluid amylase value of \> 5000 U/L on the first day).
1 week
Secondary Outcomes (1)
Position and degradation of biodegradable stents
3 months
Study Arms (2)
Biodegradable stent
Non-biodegradable stent
Interventions
Biodegradable stent (polymeric prostheses) is placed from the pancreatic duct to the jejunum. Duct-to-mucosa end-to-side anastomosis is performed for the pancreaticojejunal anastomosis.
Eligibility Criteria
Patients undergoing cephalic pancreaticoduodenectomy (Whipple procedure).
You may qualify if:
- Patients undergoing cephalic pancreaticoduodenectomy (Whipple procedure).
You may not qualify if:
- Patients with soft pancreas or chronic pancreatitis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
David Ferreras
Murcia, 30120, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 2, 2021
First Posted
March 5, 2021
Study Start
November 1, 2018
Primary Completion
December 1, 2018
Study Completion
May 1, 2021
Last Updated
March 9, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share