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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
207
Suture of the pancreas by normal stapling
Suture of the pancreas by reinforced stapling
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, France
Centre Hospitalier Universitaire Rennes Pontchaillou
Rennes, France
Unité d'hospitalisation Chirurgie hépatique, biliaire et pancréatique
Villejuif, France
Rate of postoperative pancreatic fistula defined by the criteria of the ISGPF
Time frame: up to 90 days
Gravity of the pancreatic fistula according to the 3 stages of ISGPF
Time frame: up to 90 days
Assessment of the occurrence of gastroparesis and its severity according to the criteria of ISGPS
Time frame: up to 90 days
Evaluation of the occurrence of postoperative haemorrhage
Time frame: up to 90 days
Length of hospital stay
Time frame: up to 90 days
Perioperative mortality and 90-day mortality
Time frame: up to 90 days
Overall morbidity classified and categorized according to the classification of Dindo and Clavien
Time frame: until 90 days
Rehospitalization rates
Time frame: until 90 days
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