REinforcement of the Pancreas in distaL pAncreatectomY (REPLAY)
REPLAY
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
1 other identifier
interventional
207
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2017
Typical duration for phase_3
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2017
CompletedFirst Posted
Study publicly available on registry
January 24, 2017
CompletedStudy Start
First participant enrolled
June 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2021
CompletedAugust 9, 2023
August 1, 2023
3.5 years
January 16, 2017
August 8, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of postoperative pancreatic fistula defined by the criteria of the ISGPF
up to 90 days
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (2)
Experimental
EXPERIMENTALStapling of the pancreas with ENDO GIA Reinforced reload
Control
ACTIVE COMPARATORStapling of the pancreas with ENDO GIA X-tra Thick reload
Interventions
Suture of the pancreas by normal stapling
Suture of the pancreas by reinforced stapling
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Service de chirurgie Hépato-pancréato-biliaire
Clichy, 92110, France
Service de chirurgie générale, digestive et de la transplantation hépatique
Lyon, 69317, France
AP-HM - Institut Paoli Calmettes_ service de chirurgie oncologique digestive
Marseille, 13009, France
Service de chirurgie digestive et endocrienne
Nantes, 44093, France
Institut Mutualiste Montsouris
Paris, 75674, France
Centre Hospitalier Universitaire Rennes Pontchaillou
Rennes, 35000, France
Unité d'hospitalisation Chirurgie hépatique, biliaire et pancréatique
Villejuif, 94800, France
Related Publications (1)
Merdrignac A, Garnier J, Dokmak S, Regenet N, Lesurtel M, Mabrut JY, Sa Cunha A, Fuks D, Bergeat D, Robin F, Le Pabic E, Boudjema K, Turrini O, Laviolle B, Sulpice L. Effect of the Use of Reinforced Stapling on the Occurrence of Pancreatic Fistula After Distal Pancreatectomy: Results of the REPLAY (REinforcement of the Pancreas in distaL pAncreatectomY) Multicenter Randomized Clinical Trial. Ann Surg. 2022 Nov 1;276(5):769-775. doi: 10.1097/SLA.0000000000005618. Epub 2022 Jul 25.
PMID: 35876371DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
LAURENT SULPICE, MD/PHD
RENNES PONTCHAILLOU HOSPITAL
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2017
First Posted
January 24, 2017
Study Start
June 28, 2017
Primary Completion
December 14, 2020
Study Completion
July 30, 2021
Last Updated
August 9, 2023
Record last verified: 2023-08