TissueLink Versus SEAMGUARD After Distal Pancreatectomy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2015-03-31

Brief Summary

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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 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.

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Detailed Description

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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.

Conditions

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Distal Pancreatectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

SEAMGUARD with bioabsorbable staple

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

TissueLink with radiofrequency ablation

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No