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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04783831

Enrollment

Registered

2021-03-05

Start date

2018-11-01

Completion date

2021-05-01

Last updated

2021-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreas Neoplasm, Pancreatic Anastomotic Leak, Pancreatic Cancer, Pancreatic Fistula, Stent Disintegration

Keywords

pancreaticoduodenectomy, pancreaticojejunostomy, pancreatic stent, pancreatic fistula

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).

Interventions

DEVICEBiodegradable stent

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.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients undergoing cephalic pancreaticoduodenectomy (Whipple procedure).

Exclusion criteria

* Patients with soft pancreas or chronic pancreatitis.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Position and degradation of biodegradable stents	3 months	Evaluation of the position and degradation time of the biodegradable stents

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026