Clinical trial NCT03030170: REinforcement of the Pancreas in distaL pAncreatectomY (REPLAY)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Distal Pancreatectomy (DP)
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2017-01-24
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: intervention with reinforced medical device, or not
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of postoperative pancreatic fistula defined by the criteria of the ISGPF
timeFrame: up to 90 days
Secondary outcomes:
measure: Gravity of the pancreatic fistula according to the 3 stages of ISGPF
timeFrame: up to 90 days
measure: Assessment of the occurrence of gastroparesis and its severity according to the criteria of ISGPS
timeFrame: up to 90 days
measure: Evaluation of the occurrence of postoperative haemorrhage
timeFrame: up to 90 days
measure: Length of hospital stay
timeFrame: up to 90 days
measure: Perioperative mortality and 90-day mortality
timeFrame: up to 90 days
measure: Overall morbidity classified and categorized according to the classification of Dindo and Clavien
timeFrame: until 90 days
measure: Rehospitalization rates
timeFrame: until 90 days
Other outcomes:
Locations:
city: Clichy
country: France
facility: Service de chirurgie Hépato-pancréato-biliaire
city: Lyon
country: France
facility: Service de chirurgie générale, digestive et de la transplantation hépatique
city: Marseille
country: France
facility: AP-HM - Institut Paoli Calmettes_ service de chirurgie oncologique digestive
city: Nantes
country: France
facility: Service de chirurgie digestive et endocrienne
city: Paris 14
country: France
facility: Institut Mutualiste Montsouris
city: Rennes
country: France
facility: Centre Hospitalier Universitaire Rennes Pontchaillou
city: Villejuif
country: France
facility: Unité d'hospitalisation Chirurgie hépatique, biliaire et pancréatique
Study officials:
affiliation: RENNES PONTCHAILLOU HOSPITAL
name: LAURENT SULPICE, MD/PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.