Internal Biodegradable Stent Versus Non-Stent in Patients at High-Risk of Developing Fistula After Pancreatoduodenectomy

NARecruitingINTERVENTIONAL
Enrollment

122

Participants

Timeline

Start Date

January 25, 2023

Primary Completion Date

July 31, 2026

Study Completion Date

September 30, 2026

Conditions
PancreatoduodenectomyClinically Relevant Postoperative Pancreatic FistulaInternal Biodegradable Pancreatic Stent
Interventions
DEVICE

Biodegradable Stent

A trans-anastomotic biodegradable internal stent (ARCHIMEDES™) will be placed between the main pancreatic duct (MPD) and the enterotomy in the jejunum just after the completion of the posterior suture of duct-to-mucosa. The biodegradable stent will then be shaped according to the angle of the jejunal loop in order to minimise the risk of displacement. The adequate length of the stent will be chosen according to the length of the jejunal loop.

Trial Locations (1)

20132

RECRUITING

IRCCS Ospedale San Raffaele, Milan

All Listed Sponsors
collaborator

amg International

UNKNOWN

lead

Ospedale San Raffaele

OTHER