Internal Biodegradable Stent Versus Non-Stent in Patients at High-Risk of Developing Fistula After Pancreatoduodenectomy (BioSteP): a Randomized Controlled Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The aim of this randomized controlled study is to compare the efficacy of biodegradable internal pancreatic stenting versus no stenting in patients undergoing pancreatoduodenectomy (PD), focusing on a possible superiority association of the device in preventing clinically relevant postoperative pancreatic fistula (CR-POPF). Patients undergoing PD will be randomized into two arms: * arm 1: a biodegradable internal pancreatic stent will be placed at the level of the pancreatic anastomosis * arm 2: no pancreatic stent will be placed at the level of the pancreatic anastomosis The rate of occurrence of CR-POPF will be compared between the two arms.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18

• Patients who undergo pancreatoduodenectomy (PD)

• Informed Consent

Locations
Other Locations
Italy
IRCCS Ospedale San Raffaele
RECRUITING
Milan
Contact Information
Primary
Massimo Falconi, Professor
falconi.massimo@hsr.it
0039 022643 6046
Time Frame
Start Date: 2023-01-25
Estimated Completion Date: 2026-09
Participants
Target number of participants: 122
Treatments
Experimental: Biodegradable Stent
An internal biodegradable pancreatic stent (ArchimedesTM) will be placed at the level of the pancreatic anastomosis in patients undergoing pancreatoduodenectomy.
No_intervention: Non Stent
No stent will be placed at the level of the pancreatic anastomosis in patients undergoing pancreatoduodenectomy.
Sponsors
Leads: Ospedale San Raffaele
Collaborators: amg International

This content was sourced from clinicaltrials.gov