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Minimally Invasive Surgery vs. Endoscopy Randomized (MISER) Trial for Necrotizing Pancreatitis

NCT02084537 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2019-02-11

No results posted yet for this study

Summary

Prospective, randomized controlled trial comparing Endoscopic Ultrasound (EUS) Guided cystogastrostomy or cystoduodenostomy and endoscopic necrosectomy to minimally invasive surgical necrosectomy, in patients with necrotizing pancreatitis.

Conditions

  • Necrosis of Pancreas
  • Infected Pancreatic Necrosis

Interventions

PROCEDURE

Endoscopic treatment

Treated by single or multiple transmural cystogastrostomy tracts, 15mm balloon dilation, two 7fr double pigtail plastic stents or lumen-apposing metal stents and nasocystic drainage catheter, with or without endoscopic necrosectomy as needed.

PROCEDURE

Minimally invasive surgical necrosectomy

Video-assisted retroperitoneal debridement (VARD) or laparoscopic cystogastrostomy with internal debridement.

Sponsors & Collaborators

  • AdventHealth

    lead OTHER

Principal Investigators

  • Shyam S Varadarajulu, MD · AdventHealth

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2017-12-31
Completion
2018-09-30

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 NCT02084537 on ClinicalTrials.gov