Internal Biodegradable Stent Versus Non-Stent in Patients At High-Risk of Developing Fistula After Pancreatoduodenectomy (BioSteP)

San Donato Group (GSD)

Status: Enrolling

Conditions: Clinically Relevant Postoperative Pancreatic Fistula; Internal Biodegradable Pancreatic Stent; Pancreatoduodenectomy

Treatments: Device: Biodegradable Stent

Study type: Interventional

Funder types: Other

Identifiers

NCT05668260

BioSteP

Details and patient eligibility

About

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.

Full description

Clinically relevant postoperative pancreatic fistula (CR-POPF) represents the most common complication that can occur after pancreatoduodenectomy (PD). CR-POPF is the main cause of morbidity after PD, being associated with a risk of mortality up to 60%. The placement of external or internal pancreatic stents after PD have been investigated as possible strategies for preventing the development of CR-POPF. However, device displacement has been reported as a common cause of pancreatic stents malfunction. Recently, a novel biodegradable pancreatic stent (ARCHIMEDES™) has been introduced. The device has been specifically designed to reduce the risk of displacement, thus offering a new valuable tool to decrease the rate of CR-POPF after PD.

In this randomised, controlled, single-center trial, researchers investigate the possible efficacy of biodegradable internal pancreatic stenting of pancreatic anastomosis in patient undergoing PD versus no stenting, focusing on a possible superiority association for preventing CR-POPF.

Participants will be randomised into two arms (Biodegradable stent vs non-stent) based on their intra-operative risk of developing POPF according to the Fistula Risk Score (FRS). The rate of CR-POPF will be compared between the two arms.

Enrollment: 122 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18
• Patients who undergo pancreatoduodenectomy (PD)
• Informed Consent

Exclusion criteria

• Previous distal pancreatectomy
• Patients with intra-operative negligible, intermediate or moderate risk of POPF (fistula risk score < 7)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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122 participants in 2 patient groups

Biodegradable Stent

Experimental group

Description:

An internal biodegradable pancreatic stent (ArchimedesTM) will be placed at the level of the pancreatic anastomosis in patients undergoing pancreatoduodenectomy.

Treatment:

Device: Biodegradable Stent

Non Stent

No Intervention group

Description:

No stent will be placed at the level of the pancreatic anastomosis in patients undergoing pancreatoduodenectomy.