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TissueLink Versus SEAMGUARD After Distal Pancreatectomy — PLATS  

Distal Pancreatectomy Clinical Trial

Official title:
A Multicenter Mayo-initiated Randomized Controlled Trial Comparing Pancreatic Leaks After TissueLink vs SEAMGUARD After Distal Pancreatectomy (PLATS)

Clinical Trial Summary

The purpose of this research study is to find a lowest leak rate following a distal pancreatectomy (removal of the left side of the pancreas). Distal pancreatectomy is known to have a risk of pancreatic leaks (leakage of pancreatic fluid from the cut surface of the pancreas). Two FDA cleared devices (TissueLink and SEAMGUARD) will be studied to treat and prevent leaks at the end of the pancreas.

Clinical Trial Description

The objective of this trial is to compare the effectiveness of TissueLink closure of pancreatic stump after distal pancreatectomy to that of SEAMGUARD reinforced stapler closure. Distal pancreatectomy is performed for a broad variety of indications including benign and malignant conditions. Specifically, distal pancreatectomy refers to resection of the portion of pancreas to the left of the superior mesenteric vein/portal vein trunk, excluding the duodenum and distal bile duct. Pancreatic duct leak at the resection margin is one of the most common complications of distal pancreatectomy. This complication prolongs in-patient and outpatient care and resulting in significant detriments to the patient's operative experience and increases in the financial burden of pancreatic surgery. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01051856
Study type Interventional
Source Mayo Clinic
Contact
Status Terminated
Phase Phase 4
Start date December 2009
Completion date March 2015
View Details
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