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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Biodegradable Stent
Sponsored by
Ospedale San Raffaele
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pancreatoduodenectomy focused on measuring Pancreatic surgery, Pancreatoduodenectomy, CR-POPF, Post operative complications, ARCHIMEDES™

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • IRCCS Ospedale San RaffaeleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Biodegradable Stent

Non Stent

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Clinically Relevant Postoperative Pancreatic Fistula (CR-POPF) severity
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.
Postoperative Morbidity
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.
Length of Hospital Stay (LOS)
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.
Time to Functional Recovery (TFR)
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).
Quality of Life (QoL)
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.
Cost-effectiveness
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.
Stent displacement
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.

Full Information

First Posted
December 12, 2022
Last Updated
January 26, 2023
Sponsor
Ospedale San Raffaele
Collaborators
amg International
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1. Study Identification

Unique Protocol Identification Number
NCT05668260
Brief Title
Internal Biodegradable Stent Versus Non-Stent in Patients at High-Risk of Developing Fistula After Pancreatoduodenectomy
Acronym
BioSteP
Official Title
Internal Biodegradable Stent Versus Non-Stent in Patients at High-Risk of Developing Fistula After Pancreatoduodenectomy (BioSteP): a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2023 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale San Raffaele
Collaborators
amg International

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatoduodenectomy, Clinically Relevant Postoperative Pancreatic Fistula, Internal Biodegradable Pancreatic Stent
Keywords
Pancreatic surgery, Pancreatoduodenectomy, CR-POPF, Post operative complications, ARCHIMEDES™

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Biodegradable Stent
Arm Type
Experimental
Arm Description
An internal biodegradable pancreatic stent (ArchimedesTM) will be placed at the level of the pancreatic anastomosis in patients undergoing pancreatoduodenectomy.
Arm Title
Non Stent
Arm Type
No Intervention
Arm Description
No stent will be placed at the level of the pancreatic anastomosis in patients undergoing pancreatoduodenectomy.
Intervention Type
Device
Intervention Name(s)
Biodegradable Stent
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinically Relevant Postoperative Pancreatic Fistula (CR-POPF)
Description
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.
Time Frame
from three days after surgery until 3 months after surgery
Secondary Outcome Measure Information:
Title
Clinically Relevant Postoperative Pancreatic Fistula (CR-POPF) severity
Description
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.
Time Frame
from three days after surgery until 3 months after surgery
Title
Postoperative Morbidity
Description
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.
Time Frame
from the date of surgery, up to 3 months
Title
Length of Hospital Stay (LOS)
Description
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.
Time Frame
from the date of surgery until the date of hospital discharge, assessed up to 3 months
Title
Time to Functional Recovery (TFR)
Description
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).
Time Frame
from the date of surgery until the date of functional recovery, assessed up to 3 months
Title
Quality of Life (QoL)
Description
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.
Time Frame
from the day before surgery until 3 months after surgery
Title
Cost-effectiveness
Description
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.
Time Frame
from the date of surgery, up to 3 months
Title
Stent displacement
Description
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.
Time Frame
10 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Massimo Falconi, Professor
Phone
0039 022643 6046
Email
falconi.massimo@hsr.it
Facility Information:
Facility Name
IRCCS Ospedale San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Massimo Falconi, Professor
Phone
0039 022643 6046
Email
falconi.massimo@hsr.it
First Name & Middle Initial & Last Name & Degree
Stefano Partelli, Professor
Phone
0039 022643 7697
Email
partelli.stefano@hsr.it
First Name & Middle Initial & Last Name & Degree
Stefano Partelli, Professor

12. IPD Sharing Statement

Plan to Share IPD
No
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Internal Biodegradable Stent Versus Non-Stent in Patients at High-Risk of Developing Fistula After Pancreatoduodenectomy

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