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

Sponsor

Hospital Universitario Virgen de la Arrixaca (Other)

Overall Status

Recruiting

CT.gov ID

NCT04783831

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Fistula Pancreas Neoplasm Stent Disintegration Pancreatic Cancer Pancreatic Anastomotic Leak	Device: Biodegradable stent

Study Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

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

Actual Study Start Date :

Nov 1, 2018

Actual Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

May 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Biodegradable stent	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.
Non-biodegradable stent	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.

Arm

Intervention/Treatment

Biodegradable stent

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.

Non-biodegradable stent

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.

Outcome Measures

Primary Outcome Measures

POPF [1 week]
Evaluation of the presence of POPF (drainage fluid amylase value of > 5000 U/L on the first day).

Secondary Outcome Measures

Position and degradation of biodegradable stents [3 months]
Evaluation of the position and degradation time of the biodegradable stents

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients undergoing cephalic pancreaticoduodenectomy (Whipple procedure).

Exclusion Criteria:

Patients with soft pancreas or chronic pancreatitis.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	David Ferreras	Murcia		Spain	30120

Sponsors and Collaborators

Hospital Universitario Virgen de la Arrixaca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

David Ferreras, Principal Investigator, Hospital Universitario Virgen de la Arrixaca

ClinicalTrials.gov Identifier:

NCT04783831

Other Study ID Numbers:

ARQUIMEDES

First Posted:

Mar 5, 2021

Last Update Posted:

Mar 9, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by David Ferreras, Principal Investigator, Hospital Universitario Virgen de la Arrixaca

pancreaticoduodenectomy

pancreaticojejunostomy

pancreatic stent

pancreatic fistula

Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 9, 2021