NCT01359410

Reinforced Staple Line on Leak Rate in Distal Pancreatectomy

Effect of a Reinforced Staple Line on Leak Rate in Distal Pancreatectomy

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators propose a randomized, controlled trial of stapled pancreatic transection versus mesh reinforced stapled pancreatic transection. For the duration of the study period, participating surgeons will utilize a standardized staple technique. Either a reabsorbable polytrimethylene carbonate mesh (SEAMGUARD®) or reabsorbable strips of bovine pericardium (PERI-STRIPS DRY®) will be used to reinforce the stapled pancreatic transection line in the test group. In order to have a uniform test method, the investigators will utilize a laparoscopic stapling device for both open and laparoscopic procedures and a uniform staple size (4.8mm).

Detailed description

Pancreatic leak remains a significant cause of morbidity and extra cost following distal pancreatectomy. Historically, previous attempts to reduce the leak rate have met with limited success. To examine this problem the investigators propose a randomized, controlled trial of stapled pancreatic transection versus mesh reinforced stapled pancreatic transection. For the duration of the study period, participating surgeons will utilize a standardized staple technique. Either a reabsorbable polytrimethylene carbonate mesh (SEAMGUARD®) or reabsorbable strips of bovine pericardium (PERI-STRIPS DRY®) will be used to reinforce the stapled pancreatic transection line in the test group. In order to have a uniform test method, the investigators will utilize a laparoscopic stapling device for both open and laparoscopic procedures and a uniform staple size (4.8mm). A drain will be placed in the left upper quadrant at the time of resection. Drainage of the pancreatic resection bed is widely accepted and remains our current standard of care.

Conditions

• Pancreatic Neoplasms

Interventions

Type	Name	Description
DEVICE	Mesh reinforced staple line (SEAMGUARD)	Reinforce the pancreatic transaction with SEAMGUARD®
DEVICE	Stapled without mesh reinforcement (PER-STRIPS DRY)	Stapled without mesh reinforcement (PERI-STRIPS DRY®)

Timeline

• Start date: 2007-06-01
• Primary completion: 2011-06-01
• Completion: 2011-09-01
• First posted: 2011-05-24
• Last updated: 2017-05-10
• Results posted: 2017-05-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study