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

Not Applicable

Withdrawn

• Conditions: Necrotizing Pancreatitis
• Interventions: Device: Double Pigtail Plastic Stent; Device: AXIOS Metal Stent

• 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• Status: WITHDRAWN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

Arm && Interventions

Group	Intervention	Description
Less than 50% Necrosis	Double Pigtail Plastic Stent	Subjects who have less than 50% necrosis as determined by MRI, Endoscopic Ultrasound (EUS), or direct transluminal endoscopic imaging of the collection. This stratification group will be randomized to either the double pigtail plastic stent or the AXIOS metal stent.
Less than 50% Necrosis	AXIOS Metal Stent	Subjects who have less than 50% necrosis as determined by MRI, Endoscopic Ultrasound (EUS), or direct transluminal endoscopic imaging of the collection. This stratification group will be randomized to either the double pigtail plastic stent or the AXIOS metal stent.
Greater than 50% Necrosis	Double Pigtail Plastic Stent	Subjects who have greater than 50% necrosis as determined by MRI, Endoscopic Ultrasound (EUS), or direct transluminal endoscopic imaging of the collection. This stratification group will be randomized to either the double pigtail plastic stent or the AXIOS metal stent.
Greater than 50% Necrosis	AXIOS Metal Stent	Subjects who have greater than 50% necrosis as determined by MRI, Endoscopic Ultrasound (EUS), or direct transluminal endoscopic imaging of the collection. This stratification group will be randomized to either the double pigtail plastic stent or the AXIOS metal stent.

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