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TissueLink Versus SEAMGUARD After Distal Pancreatectomy

NCT01051856 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2023-06-22

Study results available
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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.

Conditions

  • Distal Pancreatectomy

Interventions

DEVICE

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.

PROCEDURE

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.

Sponsors & Collaborators

Principal Investigators

  • Florencia G Que, M.D. S · Mayo Clinic, Rochester, MN

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2014-03-31
Completion
2015-03-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT01051856 on ClinicalTrials.gov