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The purpose of this research study is to find a lowest leak rate following a distal pancreatectomy (removal of the left side of your pancreas). Distal pancreatectomy is known to have a risk of pancreatic leaks (leakage of pancreatic fluid from the cut surface of the pancreas). We are studying two FDA approved devices to treat and prevent leaks at the end of the pancreas. These two methods are Tissuelink and Seamguard. The study may help us understand which treatment will have a lower leak rate.
The primary objective of this trial is to compare the effectiveness of Tissuelink closure of pancreatic stump after distal pancreatectomy to Seamguard.
The secondary objective of this trial is to compare the severity of leaks in the two groups using the ISGPF grading system.
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 prolonging inpatient and outpatient care and resulting in clinically important increases in the financial burden of pancreatic surgery.
Thus, a randomized, prospective, human trial comparing Tissuelink vs Seamguard may help us answer the question of which method is best to treat the pancreatic stump.
Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Seamguard with bioabsorbable staple, Tissuelink w/radiofrequency ablation
Enrolling by invitation
Published on BioPortfolio: 2014-08-27T03:16:33-0400
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