REinforcement of the Pancreas in distaL pAncreatectomY (REPLAY)

Study Overview
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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.

Official Title
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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

Conditions
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Distal Pancreatectomy (DP)

Intervention / Treatment
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* Device: ENDO GIA X-tra Thick reload with Tri Staple Technology
* Device: ENDO GIA Articulating Reinforced Reload with Tri-Staple Technology


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: intervention with reinforced medical device, or not
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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