TissueLink Versus SEAMGUARD After Distal Pancreatectomy

Phase 4

Terminated

• Conditions: Distal Pancreatectomy
• Interventions: Procedure: TissueLink with radiofrequency ablation; Device: SEAMGUARD with bioabsorbable staple

• Registration Number: NCT01051856
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed 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 Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-01-15
• Study First Submitted QC: 2010-01-19
• Study First Posted: 2010-01-20
• Primary Completion: 2014-03
• Study Completion: 2015-03
• Results First Submitted: 2015-05-29
• Results First Submitted QC: 2015-05-29
• Results First Posted: 2015-06-12
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-19
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TissueLink with radiofrequency ablation	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.
SEAMGUARD with bioabsorbable staple	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Who Developed a Postoperative Pancreatic Duct Leak at the Resection Margin (Pancreatic Fistula) Within 90 Days From the Operation	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.

Secondary Outcome Measures

Name	Time	Method
Severity of the Pancreatic Fistula Leaks	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.

Trial Locations

Locations (2)

Massachusettes General Hospital; 🇺🇸 Boston, Massachusetts, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States