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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04783831
• Other study ID #: ARQUIMEDES
• Status: Recruiting
• Start date: November 1, 2018
• Est. completion date: May 1, 2021

Study information

• Verified date: March 2021
• Source: Hospital Universitario Virgen de la Arrixaca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 1, 2021
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing cephalic pancreaticoduodenectomy (Whipple procedure).

Exclusion Criteria:

• Patients with soft pancreas or chronic pancreatitis.

Related Conditions & MeSH terms

• Anastomotic Leak
• Fistula
• Pancreas Neoplasm
• Pancreatic Anastomotic Leak
• Pancreatic Cancer
• Pancreatic Fistula
• Pancreatic Neoplasms
• Stent Disintegration

Intervention

Device:
• Biodegradable 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.

Locations

Country	Name	City	State
Spain	David Ferreras	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Virgen de la Arrixaca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	POPF	Evaluation of the presence of POPF (drainage fluid amylase value of > 5000 U/L on the first day).	1 week
Secondary	Position and degradation of biodegradable stents	Evaluation of the position and degradation time of the biodegradable stents	3 months