REinforcement of the Pancreas in distaL pAncreatectomY (REPLAY)
- Conditions
- Distal Pancreatectomy (DP)
- Interventions
- Device: ENDO GIA Articulating Reinforced Reload with Tri-Staple TechnologyDevice: ENDO GIA X-tra Thick reload with Tri Staple Technology
- Registration Number
- NCT03030170
- Lead Sponsor
- Rennes University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 207
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental ENDO GIA Articulating Reinforced Reload with Tri-Staple Technology Stapling of the pancreas with ENDO GIA Reinforced reload Control ENDO GIA X-tra Thick reload with Tri Staple Technology Stapling of the pancreas with ENDO GIA X-tra Thick reload
- Primary Outcome Measures
Name Time Method Rate of postoperative pancreatic fistula defined by the criteria of the ISGPF up to 90 days
- Secondary Outcome Measures
Name Time Method Length of hospital stay up to 90 days Perioperative mortality and 90-day mortality up to 90 days 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 Rehospitalization rates until 90 days Overall morbidity classified and categorized according to the classification of Dindo and Clavien until 90 days
Trial Locations
- Locations (7)
Service de chirurgie Hépato-pancréato-biliaire
🇫🇷Clichy, France
Service de chirurgie générale, digestive et de la transplantation hépatique
🇫🇷Lyon, France
AP-HM - Institut Paoli Calmettes_ service de chirurgie oncologique digestive
🇫🇷Marseille, France
Service de chirurgie digestive et endocrienne
🇫🇷Nantes, France
Institut Mutualiste Montsouris
🇫🇷Paris 14, France
Centre Hospitalier Universitaire Rennes Pontchaillou
🇫🇷Rennes, France
Unité d'hospitalisation Chirurgie hépatique, biliaire et pancréatique
🇫🇷Villejuif, France