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

Virgen de la Arrixaca University Clinical Hospital (HCUVA)

Status: Unknown

Conditions: Pancreatic Fistula; Pancreatic Anastomotic Leak; Pancreas Neoplasm; Stent Disintegration; Pancreatic Cancer

Treatments: Device: Biodegradable stent

Study type: Observational

Funder types: Other

Identifiers

NCT04783831

ARQUIMEDES

Details and patient eligibility

About

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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing cephalic pancreaticoduodenectomy (Whipple procedure).

Exclusion criteria

• Patients with soft pancreas or chronic pancreatitis.

Trial design

60 participants in 2 patient groups

Biodegradable stent

Treatment:

Device: Biodegradable stent

Non-biodegradable stent

Treatment:

Device: Biodegradable stent