TissueLink Versus SEAMGUARD After Distal Pancreatectomy (PLATS)
|Distal Pancreatectomy||Device: SEAMGUARD with bioabsorbable staple Procedure: TissueLink with radiofrequency ablation||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
|Official Title:||A Multicenter Mayo-initiated Randomized Controlled Trial Comparing Pancreatic Leaks After TissueLink vs SEAMGUARD After Distal Pancreatectomy (PLATS)|
- Percentage of Subjects Who Developed a Postoperative Pancreatic Duct Leak at the Resection Margin (Pancreatic Fistula) Within 90 Days From the Operation [ Time Frame: 90 days from the operation ]Pancreatic fistula was defined as amylase-rich (greater than 3 times upper limit of normal serum amylase for the treating institution) fluid either in the operatively placed drain or upon reinsertion of an image-guided drain for postoperative fluid collection.
- Severity of the Pancreatic Fistula Leaks [ Time Frame: 90 days post operative ]Grading of the clinical severity of the leak was done according to the International Study Group on Pancreatic Fistula criteria. Severity of fistula was reported as clinically significant (Grades B and C) or not (Grade A). Grade C indicates the most severe clinical outcome.
|Study Start Date:||December 2009|
|Study Completion Date:||March 2015|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Active Comparator: SEAMGUARD with bioabsorbable staple
In this arm pancreatic transection will be executed using an endoscopic linear stapling device. The individual staple depth can be chosen by the operating surgeon. Bioabsorbable Mesh sleeves specifically manufactured for the chosen staple depth and cartridge length will be placed over the stapler before firing.
Device: SEAMGUARD with bioabsorbable staple
In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device.
Active Comparator: TissueLink with radiofrequency ablation
After pancreatic transection, with any method chosen by the operating surgeon, the pancreatic remnant will be treated with TissueLink alone for an ablation depth (thickness) of approximately 7 mm using electrosurgical generator settings of 100 W and a saline drip rate of 1-2 drops per second.
Procedure: TissueLink with radiofrequency ablation
After pancreatic transection with the method of choice of the operating surgeon, the pancreatic remnant will be treated with Tissuelink alone for an ablation depth (thickness) of approximately 7 mm.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01051856
|United States, Massachusetts|
|Massachusettes General Hospital|
|Boston, Massachusetts, United States, 02144|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Florencia G Que, M.D. S||Mayo Clinic, Rochester, MN|