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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 (NCT03030170)

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.
  • Device: ENDO GIA X-tra Thick reload with Tri Staple Technology
    Suture of the pancreas by normal stapling
    • Device: ENDO GIA Articulating Reinforced Reload with Tri-Staple Technology
      Suture of the pancreas by reinforced stapling
      Ages eligible for Study
      18 Years and older
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      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

      6 locations

      France (6)
      • Service de chirurgie Hépato-pancréato-biliaire
        not yet recruiting
        Clichy, France, 92110
      • Service de chirurgie générale, digestive et de la transplantation hépatique
        not yet recruiting
        Lyon, France, 69317
      • AP-HM - Institut Paoli Calmettes_ service de chirurgie oncologique digestive
        not yet recruiting
        Marseille, France, 13009
      • Service de chirurgie digestive et endocrienne
        not yet recruiting
        Nantes, France, 44093
      • Centre Hospitalier Universitaire Rennes Pontchaillou
        Rennes, France, 35000
      • Unité d'hospitalisation Chirurgie hépatique, biliaire et pancréatique
        not yet recruiting
        Villejuif, France, 94800
      Status:
      not yet recruiting
      Type:
      Interventional
      Phase:
      Start:
      31 January, 2017
      Updated:
      06 February, 2017
      Participants:
      200
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