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

Endoscopic Large Caliber Drainage vs. Complete Necrosectomy for Treatment of Walled-off Pancreatic Necrosis: A Prospective, Randomized Noninferiority Trial.

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

Study Overview

• Status: Withdrawn
• Conditions: Necrotizing Pancreatitis
• Intervention / Treatment: Device: Double Pigtail Plastic Stent; Device: AXIOS Metal Stent

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Greater than 50% Necrosis; 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.	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; Other Names: LC-SEMS; Large caliber- self-expanding metal stent
Other: Less than 50% Necrosis; 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.	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; Other Names: LC-SEMS; Large caliber- self-expanding metal stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
Symptom resolution (Visual Analogue Scale for pain, gastric outlet obstruction, and weight gain)	Baseline to 4 months after initiation of endoscopic treatment
Decrease in incidence of adverse events	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
Decrease in total costs of pancreatitis-related health care during treatment course	Baseline to 4 months after initiation of endoscopic treatment

Collaborators and Investigators

• Sponsor: Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2019
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: September 29, 2015
• First Submitted That Met QC Criteria: September 30, 2015
• First Posted (Estimate): October 1, 2015

Study Record Updates

• Last Update Posted (Actual): April 19, 2019
• Last Update Submitted That Met QC Criteria: April 17, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Acute Necrotizing Pancreatitis; Walled-Off Pancreatic Necrosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Pancreatic Diseases; Necrosis; Pancreatitis; Pancreatitis, Acute Necrotizing
• Other Study ID Numbers: 14-001390

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No