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

NCT02564965 | Withdrawn FDA Device

• 1 other identifier: 14-001390
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Necrotizing Pancreatitis

Keywords

Acute Necrotizing Pancreatitis; Walled-Off Pancreatic Necrosis

Outcome Measures

Primary Outcomes (1)

• Complete resolution as defined by complete radiographic resolution of the walled-off necrosis (WON)

  Baseline to 4 months after initiation of endoscopic treatment

Secondary Outcomes (5)

• 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

Study Arms (2)

Greater than 50% Necrosis

OTHER

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; Device: AXIOS Metal Stent

Less than 50% Necrosis

OTHER

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; Device: AXIOS Metal Stent

Interventions

Double Pigtail Plastic Stent DEVICE

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

Greater than 50% Necrosis; Less than 50% Necrosis

AXIOS Metal Stent DEVICE

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

Also known as: LC-SEMS, Large caliber- self-expanding metal stent

Greater than 50% Necrosis; Less than 50% Necrosis

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Pancreatitis, Acute Necrotizing

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases

Study Officials

• Barham Abu Dayyeh, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: October 1, 2015
• Study Start: February 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: April 19, 2019

Record last verified: 2019-04