Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreas Neoplasm | Pancreatic Neoplasm | ALIAS | 0.90 |
| Pancreatic Anastomotic Leak | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Fistula | — | UNRESOLVED | — |
| Stent Disintegration | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biodegradable stent | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Biodegradable stent
- interventionNames
- Device: Biodegradable stent
- label
- Non-biodegradable stent
- interventionNames
- Device: Biodegradable stent
Primary outcomes (1)
- measure
- POPF
- timeFrame
- 1 week
- description
- Evaluation of the presence of POPF (drainage fluid amylase value of \> 5000 U/L on the first day).
Secondary outcomes (1)
- measure
- Position and degradation of biodegradable stents
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients undergoing cephalic pancreaticoduodenectomy (Whipple procedure). Exclusion Criteria: * Patients with soft pancreas or chronic pancreatitis.
References
Publications (0)
Data not yet available