REinforcement of the Pancreas in distaL pAncreatectomY (REPLAY)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-28

Study Completion Date

2021-07-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Distal Pancreatectomy (DP)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

intervention with reinforced medical device, or not

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Experimental

Stapling of the pancreas with ENDO GIA Reinforced reload

Group Type EXPERIMENTAL

ENDO GIA Articulating Reinforced Reload with Tri-Staple Technology

Intervention Type DEVICE

Suture of the pancreas by reinforced stapling

Control

Stapling of the pancreas with ENDO GIA X-tra Thick reload

Group Type ACTIVE_COMPARATOR

ENDO GIA X-tra Thick reload with Tri Staple Technology

Intervention Type DEVICE

Suture of the pancreas by normal stapling

Interventions

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ENDO GIA X-tra Thick reload with Tri Staple Technology

Suture of the pancreas by normal stapling

Intervention Type DEVICE

ENDO GIA Articulating Reinforced Reload with Tri-Staple Technology

Suture of the pancreas by reinforced stapling

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No