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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 207
- Locations
- 14
- Primary Endpoint
- Rate of postoperative pancreatic fistula defined by the criteria of the ISGPF
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
Rate of postoperative pancreatic fistula defined by the criteria of the ISGPF
Time Frame: up to 90 days
Secondary Outcomes
- 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)