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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
207

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rennes University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 28, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 14, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2017

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 24, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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