NCT03030170

REinforcement of the Pancreas in distaL pAncreatectomY (REPLAY)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Distal Pancreatectomy (DP)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-06-28
• Primary completion: 2020-12-14
• Completion: 2021-07-30
• First posted: 2017-01-24
• Last updated: 2023-08-09

Locations

7 sites across 1 country: France