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

Not Applicable

Withdrawn

• Conditions: Necrotizing Pancreatitis

• Registration Number: NCT02564965
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-29
• Study First Submitted QC: 2015-09-30
• Study First Posted: 2015-10-01
• Study Start: 2019-02
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-17
• Last Update Posted: 2019-04-19
• Primary Completion: 2019-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Adult (> 18 yo) patients
• With symptomatic walled- off pancreatic necrosis in which an endoscopic approach is appropriate based on cross-sectional imaging
• Must have solid necrotic material present in their pancreatic fluid collection as determined by MRI, EUS, or direct transluminal endoscopic imaging of the collection

Exclusion Criteria

• Previous intervention for pancreatic necrosis (surgical, percutaneous, or endoscopic)
• Indication for emergency laparotomy (compartment syndrome, bowel ischemia, bleeding, or perforation of a GI lumen)
• Uncorrectable coagulopathy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Complete resolution as defined by complete radiographic resolution of the walled-off necrosis (WON)	Baseline to 4 months after initiation of endoscopic treatment

Secondary Outcome Measures

Name	Time	Method
Decrease in total costs of pancreatitis-related health care during treatment course	Baseline to 4 months after initiation of endoscopic treatment
Clinical resolution of infection as defined by complete radiographic resolution and/or symptoms of pain and gastric outlet obstruction	Baseline to 4 months after initiation of endoscopic treatment
Decrease in incidence of adverse events	Baseline to 4 months after initiation of endoscopic treatment
Symptom resolution (Visual Analogue Scale for pain, gastric outlet obstruction, and weight gain)	Baseline to 4 months after initiation of endoscopic treatment
Decrease in number of hospital days during treatment course	Baseline to 4 months after initiation of endoscopic treatment