Reinforced Staple Line on Leak Rate in Distal Pancreatectomy

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2011-09-30

Brief Summary

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The investigators propose a randomized, controlled trial of stapled pancreatic transection versus mesh reinforced stapled pancreatic transection. For the duration of the study period, participating surgeons will utilize a standardized staple technique. Either a reabsorbable polytrimethylene carbonate mesh (SEAMGUARD®) or reabsorbable strips of bovine pericardium (PERI-STRIPS DRY®) will be used to reinforce the stapled pancreatic transection line in the test group. In order to have a uniform test method, the investigators will utilize a laparoscopic stapling device for both open and laparoscopic procedures and a uniform staple size (4.8mm).

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Detailed Description

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Pancreatic leak remains a significant cause of morbidity and extra cost following distal pancreatectomy. Historically, previous attempts to reduce the leak rate have met with limited success. To examine this problem the investigators propose a randomized, controlled trial of stapled pancreatic transection versus mesh reinforced stapled pancreatic transection. For the duration of the study period, participating surgeons will utilize a standardized staple technique. Either a reabsorbable polytrimethylene carbonate mesh (SEAMGUARD®) or reabsorbable strips of bovine pericardium (PERI-STRIPS DRY®) will be used to reinforce the stapled pancreatic transection line in the test group. In order to have a uniform test method, the investigators will utilize a laparoscopic stapling device for both open and laparoscopic procedures and a uniform staple size (4.8mm). A drain will be placed in the left upper quadrant at the time of resection. Drainage of the pancreatic resection bed is widely accepted and remains our current standard of care.

Conditions

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Pancreatic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Participant's were blinded to the results of the randomization for 6 weeks.

Study Groups

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Stapled transection with mesh reinforcement

Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)

Group Type ACTIVE_COMPARATOR

Mesh reinforced staple line (SEAMGUARD)

Intervention Type DEVICE

Reinforce the pancreatic transaction with SEAMGUARD®

Stapled without mesh reinforcement (PER-STRIPS DRY)

Intervention Type DEVICE

Stapled without mesh reinforcement (PERI-STRIPS DRY®)

Stapled transection without mesh reinforcement

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mesh reinforced staple line (SEAMGUARD)

Reinforce the pancreatic transaction with SEAMGUARD®

Intervention Type DEVICE

Stapled without mesh reinforcement (PER-STRIPS DRY)

Stapled without mesh reinforcement (PERI-STRIPS DRY®)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Participants must be 18 years or older and able to give consent. Any patient undergoing a distal pancreatectomy, laparoscopic or open, will be eligible for randomization.
* No exclusion is provided for primary diagnosis. In the event of a patient undergoing a planned resection of another organ or organs with only a possibility of a distal pancreatic resection (i.e. colectomy, hepatectomy, gastrectomy, nephrectomy), the patient will still be eligible for inclusion in the study. We expect that some patients will be randomized but not resected (ie metastasis identified). A few patients may not be stapled using the study device for technical reasons (ie the stapler does not fit). The data will be analyzed in an intent-to-treatment approach.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No