REinforcement of the Pancreas in distaL pAncreatectomY (REPLAY)

Rennes University Hospital

Status and phase

Completed

Phase 3

Conditions

Distal Pancreatectomy (DP)

Treatments

Device: ENDO GIA X-tra Thick reload with Tri Staple Technology

Device: ENDO GIA Articulating Reinforced Reload with Tri-Staple Technology

Study type

Interventional

Funder types

Other

Identifiers

NCT03030170

35RC15_9846

Details and patient eligibility

About

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.

Enrollment

207 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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