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Reinforced Staple Line on Leak Rate in Distal Pancreatectomy

NCT01359410 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2017-05-10

Study results available
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Summary

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).

Conditions

  • Pancreatic Neoplasms

Interventions

DEVICE

Mesh reinforced staple line (SEAMGUARD)

Reinforce the pancreatic transaction with SEAMGUARD®

DEVICE

Stapled without mesh reinforcement (PER-STRIPS DRY)

Stapled without mesh reinforcement (PERI-STRIPS DRY®)

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • William Hawkins, M.D. · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2011-06-30
Completion
2011-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01359410 on ClinicalTrials.gov