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Endoscopic Large Caliber Drainage vs. Complete Necrosectomy for Treatment of Walled-off Pancreatic Necrosis

NCT02564965 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-04-19

No results posted yet for this study

Summary

The purpose of this study is to determine optimal treatment strategies for symptomatic walled-off pancreatic necrosis( WON).

Conditions

  • Necrotizing Pancreatitis

Interventions

DEVICE

Double Pigtail Plastic Stent

Patients will be stratified into two arms (Greater than 50% necrosis or less than 50% necrosis), then will be randomized to either the double pigtail plastic stent or AXIOS metal stent

DEVICE

AXIOS Metal Stent

Patients will be stratified into two arms (Greater than 50% necrosis or less than 50% necrosis), then will be randomized to either the double pigtail plastic stent or AXIOS metal stent

Sponsors & Collaborators

Principal Investigators

  • Barham Abu Dayyeh, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-28
Primary Completion
2019-12-31
Completion
2020-12-31
FDA Device
Yes

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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 NCT02564965 on ClinicalTrials.gov