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

March 12, 2025 updated by: Stefano Partelli, Ospedale San Raffaele

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Milan, Italy, 20132
        • Recruiting
        • IRCCS Ospedale San Raffaele
        • Contact:
        • Contact:
        • Contact:
          • Stefano Partelli, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biodegradable Stent
An internal biodegradable pancreatic stent (ArchimedesTM) will be placed at the level of the pancreatic anastomosis in patients undergoing pancreatoduodenectomy.
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.
No Intervention: Non Stent
No stent will be placed at the level of the pancreatic anastomosis in patients undergoing pancreatoduodenectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinically Relevant Postoperative Pancreatic Fistula (CR-POPF)
Time Frame: from three days after surgery until 3 months after surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinically Relevant Postoperative Pancreatic Fistula (CR-POPF) severity
Time Frame: from three days after surgery until 3 months after surgery
The difference between the two treatment arms in terms of severity of CR-POPF will be assessed. CR-POPF will be classified according to the ISGPS definition into two groups: grade B and grade C. Grade B will be further sub-classified in three categories according to Maggino et al.: grade B1, grade B2, grade B3.
from three days after surgery until 3 months after surgery
Postoperative Morbidity
Time Frame: from the date of surgery, up to 3 months
The difference between the two treatment arms in terms of rate of overall postoperative morbidity as defined by Dindo et al. will be assessed. Additionally the Comprehensive Complication Index will be calculated. Post-pancreatectomy hemorrhage (PPH) and delayed gastric emptying (DGE) will be defined according to ISGPS definitions.
from the date of surgery, up to 3 months
Length of Hospital Stay (LOS)
Time Frame: from the date of surgery until the date of hospital discharge, assessed up to 3 months
The difference between the two treatment arms in terms of median LOS will be assessed. Median LOS will be defined by subtracting the date of surgery from the date when the enrolled patients are discharged from the hospital.
from the date of surgery until the date of hospital discharge, assessed up to 3 months
Time to Functional Recovery (TFR)
Time Frame: from the date of surgery until the date of functional recovery, assessed up to 3 months
The difference between the two treatment arms in terms of time to functional recovery (TFR) will be assessed. TFR will be defined by subtracting the date of surgery from the date when participants achieve standardized criteria (tolerance of oral intake, recovery of lower gastrointestinal function, adequate pain control on oral analgesia, ability to mobilise and self-care and no evidence of untreated medical problems).
from the date of surgery until the date of functional recovery, assessed up to 3 months
Quality of Life (QoL)
Time Frame: from the day before surgery until 3 months after surgery
The difference between the two treatment arms in terms of QoL will be assessed. QoL will be measured in several ways. First, self-reported activity status will be measured using the Duke Activity Status Index (Duke Index, DASI)., a brief questionnaire designed to assess physical function and predict exercise capacity (peak oxygen uptake). Second, generic health related QoL will be measured using the Patient Reported Outcome Measure Information System (PROMIS)-29+2 Profile v2.1 (PROPr), a questionnaire designed to measure self-reported physical, mental and social health and wellbeing.
from the day before surgery until 3 months after surgery
Cost-effectiveness
Time Frame: from the date of surgery, up to 3 months
The difference between the two treatment arms in terms of cost-effectiveness will be assessed. Cost-effectiveness will be estimated by the ration of differences in costs to differences in quality adjusted life years (QALYs) between the two groups of the study. QALYs will be calculated using the preference scores obtained from PROMIS-29+2. To calculate QALYs, the preference scores at 90 days after surgery will be multiplied by 0.25 (which represents 1/4 of the year). Cost of care will be estimated considering resources consumed during hospital stay and use of healthcare resources after hospital discharge.
from the date of surgery, up to 3 months
Stent displacement
Time Frame: 10 days after surgery
The rate of biodegradable rate displacement as detected by postoperative contrast-enhanced computed tomography (CE-CT) performed by 10 days after surgery. A displacement will be defined by the absence of visible trans-anastomotic stent or by its complete dislocation in the jejunum/ileum or colon.
10 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale San Raffaele

Collaborators

amg International

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

December 12, 2022

First Submitted That Met QC Criteria

December 20, 2022

First Posted (Actual)

December 29, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 12, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BioSteP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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