REinforcement of the Pancreas in distaL pAncreatectomY (REPLAY) (REPLAY)

August 8, 2023 updated by: Rennes University Hospital

Does the Strengthening of the Pancreas in Distal Pancreatectomy Using Endo GIA Reload Reinforced Reduce the Occurrence of Pancreatic Fistula? Multicenter Randomized Prospective Open Study

Despite an improvement regarding morbidity and mortality since 30 years, especially in expert centers, pancreatic surgery remains currently associated to a significant postoperative morbidity reaching more than 60%. Regarding distal pancreatectomy (DP), the main complication following surgery is the occurrence of postoperative pancreatic fistula (PF) which may be able to lead an increased risk of bleeding, gastroparesis and finally a longer hospital stays. The main risk factors associated to the occurrence of pancreatic fistula are represented by the texture of the pancreatic parenchyma (soft pancreas) and the caliber of the main pancreatic duct (<3mm). Looking for new means of reducing the occurrence of pancreatic fistula is a priority in pancreatic surgery and a genuine public health issue. Currently, no formal recommendations concerning the optimal technical for closure of the distal stump in DP are available. In fact, manual closing by elective suturing or stapling of the main pancreatic duct give similar results. The use of a reinforcing stapling potentially represents a simple way to decrease the occurrence of pancreatic fistula and requires evaluation by a prospective randomized study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

207

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

  • France
      • Clichy, France, 92110
        • Service de chirurgie Hépato-pancréato-biliaire
      • Lyon, France, 69317
        • Service de chirurgie générale, digestive et de la transplantation hépatique
      • Marseille, France, 13009
        • AP-HM - Institut Paoli Calmettes_ service de chirurgie oncologique digestive
      • Nantes, France, 44093
        • Service de chirurgie digestive et endocrienne
      • Paris 14, France, 75674
        • Institut Mutualiste Montsouris
      • Rennes, France, 35000
        • Centre Hospitalier Universitaire Rennes Pontchaillou
      • Villejuif, France, 94800
        • Unité d'hospitalisation Chirurgie hépatique, biliaire et pancréatique

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:

  • All patients who undergo DP whether made by open or laparoscopic surgery
  • Patients 18 years of age or older,
  • Benefiting from a social security scheme,
  • Having given his free, informed and written consent.

Exclusion Criteria:

  • History of pancreatic abdominal surgery
  • Severe co-morbidity type renal failure requiring hemodialysis, unbalanced diabetes, major respiratory insufficiency, heart failure ≥ stage 3 NYHA;
  • Persons of full age who are subject to legal protection, persons deprived of liberty.
  • Pregnant or nursing women
  • Patients participating in or participating in another study

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Stapling of the pancreas with ENDO GIA Reinforced reload
Device: ENDO GIA Articulating Reinforced Reload with Tri-Staple Technology
Suture of the pancreas by reinforced stapling
Active Comparator: Control
Stapling of the pancreas with ENDO GIA X-tra Thick reload
Device: ENDO GIA X-tra Thick reload with Tri Staple Technology
Suture of the pancreas by normal stapling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of postoperative pancreatic fistula defined by the criteria of the ISGPF
Time Frame: up to 90 days
up to 90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Length of hospital stay
Time Frame: up to 90 days
up to 90 days
Gravity of the pancreatic fistula according to the 3 stages of ISGPF
Time Frame: up to 90 days
up to 90 days
Assessment of the occurrence of gastroparesis and its severity according to the criteria of ISGPS
Time Frame: up to 90 days
up to 90 days
Evaluation of the occurrence of postoperative haemorrhage
Time Frame: up to 90 days
up to 90 days
Perioperative mortality and 90-day mortality
Time Frame: up to 90 days
up to 90 days
Overall morbidity classified and categorized according to the classification of Dindo and Clavien
Time Frame: until 90 days
until 90 days
Rehospitalization rates
Time Frame: until 90 days
until 90 days

Collaborators and Investigators

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

Sponsor

Rennes University Hospital

Investigators

  • Principal Investigator: LAURENT SULPICE, MD/PHD, RENNES PONTCHAILLOU HOSPITAL

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)

June 28, 2017

Primary Completion (Actual)

December 14, 2020

Study Completion (Actual)

July 30, 2021

Study Registration Dates

First Submitted

January 16, 2017

First Submitted That Met QC Criteria

January 23, 2017

First Posted (Estimated)

January 24, 2017

Study Record Updates

Last Update Posted (Actual)

August 9, 2023

Last Update Submitted That Met QC Criteria

August 8, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 35RC15_9846

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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