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

NCT05668260 | Recruiting

• 1 other identifier: BioSteP
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Pancreatic surgery; Pancreatoduodenectomy; CR-POPF; Post operative complications; ARCHIMEDES™

Outcome Measures

Primary Outcomes (1)

• Clinically Relevant Postoperative Pancreatic Fistula (CR-POPF)

  The primary objective of the study is to compare the rate of CR-POPF after PD with duct-to-mucosa pancreatico-jejunostomy (PJ) using biodegradable pancreatic internal stent vs no stent.

  from three days after surgery until 3 months after surgery

Secondary Outcomes (7)

• Clinically Relevant Postoperative Pancreatic Fistula (CR-POPF) severity

  from three days after surgery until 3 months after surgery

• Postoperative Morbidity

  from the date of surgery, up to 3 months

• Length of Hospital Stay (LOS)

  from the date of surgery until the date of hospital discharge, assessed up to 3 months

• Time to Functional Recovery (TFR)

  from the date of surgery until the date of functional recovery, assessed up to 3 months

• Quality of Life (QoL)

  from the day before surgery until 3 months after surgery

Study Arms (2)

Biodegradable Stent

EXPERIMENTAL

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

Device: Biodegradable Stent

Non Stent

NO INTERVENTION

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

Interventions

Biodegradable Stent DEVICE

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.

Biodegradable Stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ospedale San Raffaele: lead
• amg International: collaborator

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, Milan, 20132, Italy

RECRUITING

Related Publications (19)

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Central Study Contacts

Massimo Falconi, Professor

CONTACT

0039 022643 6046; falconi.massimo@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: December 29, 2022
• Study Start: January 25, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)