TissueLink Versus SEAMGUARD After Distal Pancreatectomy

Phase 4TerminatedNCT01051856

Mayo Clinic68 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Distal Pancreatectomy

Interventions

SEAMGUARD with bioabsorbable stapleDEVICE

In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device.

TissueLink with radiofrequency ablationPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. Age equal or above 18 years 2. Accepted for elective distal pancreatectomy for any indication Exclusion from randomization process: * Thickness of pancreas on preoperative CT scan images \> 2.5 cm at the site of expected transection in anterior-posterior diameter. This will be reviewed by the surgeon the day before the surgeon sees the patient to predetermine the appropriateness of the patient for the study. General study exclusion criteria: 1. Current immunosuppressive therapy 2. Chemotherapy within 2 weeks before operation 3. Bevacizumab (Avastin™) treatment not completed at least 6 weeks before operation 4. Radiotherapy before operation 5. Inability to follow the instructions given by the investigator 6. Lack of compliance 7. Persons unable or unwilling to give informed consent to participate in this study 8. Pregnant women 9. Prisoners 10. Institutionalized individuals

Locations (2)

Massachusettes General Hospital

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Percentage of Subjects Who Developed a Postoperative Pancreatic Duct Leak at the Resection Margin (Pancreatic Fistula) Within 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.

Time frame: 90 days from the operation

Secondary Outcomes

Severity of the Pancreatic Fistula Leaks

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.

Time frame: 90 days post operative

Data from ClinicalTrials.gov

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