Biodegradable Pancreatic Stents for the Prevention of Postoperative Pancreatic Fistula After Cephalic Pancreaticoduodenectomy

• Conditions: Pancreatic Fistula; Stent Disintegration; Pancreas Neoplasm; Pancreatic Cancer; Pancreatic Anastomotic Leak
• Interventions: Device: Biodegradable stent

• Registration Number: NCT04783831
• Lead Sponsor: Hospital Universitario Virgen de la Arrixaca

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-01
• Primary Completion: 2018-12-01
• Status Verified: 2021-03
• Study First Submitted: 2021-03-02
• Study First Submitted QC: 2021-03-04
• Study First Posted: 2021-03-05
• Last Update Submitted: 2021-03-07
• Last Update Posted: 2021-03-09
• Study Completion: 2021-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients undergoing cephalic pancreaticoduodenectomy (Whipple procedure).

Exclusion Criteria

• Patients with soft pancreas or chronic pancreatitis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Biodegradable stent	Biodegradable stent	-
Non-biodegradable stent	Biodegradable stent	-

Primary Outcome Measures

Name	Time	Method
POPF	1 week	Evaluation of the presence of POPF (drainage fluid amylase value of \> 5000 U/L on the first day).

Secondary Outcome Measures

Name	Time	Method
Position and degradation of biodegradable stents	3 months	Evaluation of the position and degradation time of the biodegradable stents

Trial Locations

Locations (1)

David Ferreras; 🇪🇸 Murcia, Spain