Back to resultsEndoscopic Large Caliber Drainage vs. Complete Necrosectomy for Treatment of Walled-off Pancreatic Necrosis
Primary Purpose
Necrotizing Pancreatitis
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Double Pigtail Plastic Stent
AXIOS Metal Stent
Sponsored by
About this trial
This is an interventional treatment trial for Necrotizing Pancreatitis focused on measuring Acute Necrotizing Pancreatitis, Walled-Off Pancreatic Necrosis
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Greater than 50% Necrosis
Less than 50% Necrosis
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Complete resolution as defined by complete radiographic resolution of the walled-off necrosis (WON)
Secondary Outcome Measures
Clinical resolution of infection as defined by complete radiographic resolution and/or symptoms of pain and gastric outlet obstruction
Symptom resolution (Visual Analogue Scale for pain, gastric outlet obstruction, and weight gain)
Decrease in incidence of adverse events
Decrease in number of hospital days during treatment course
Decrease in total costs of pancreatitis-related health care during treatment course
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02564965
Brief Title
Endoscopic Large Caliber Drainage vs. Complete Necrosectomy for Treatment of Walled-off Pancreatic Necrosis
Official Title
Endoscopic Large Caliber Drainage vs. Complete Necrosectomy for Treatment of Walled-off Pancreatic Necrosis: A Prospective, Randomized Noninferiority Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding
Study Start Date
February 2019 (Anticipated)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine optimal treatment strategies for symptomatic walled-off pancreatic necrosis( WON).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrotizing Pancreatitis
Keywords
Acute Necrotizing Pancreatitis, Walled-Off Pancreatic Necrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Greater than 50% Necrosis
Arm Type
Other
Arm Description
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.
Arm Title
Less than 50% Necrosis
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Double Pigtail Plastic Stent
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
AXIOS Metal Stent
Other Intervention Name(s)
LC-SEMS, Large caliber- self-expanding metal stent
Intervention Description
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
Primary Outcome Measure Information:
Title
Complete resolution as defined by complete radiographic resolution of the walled-off necrosis (WON)
Time Frame
Baseline to 4 months after initiation of endoscopic treatment
Secondary Outcome Measure Information:
Title
Clinical resolution of infection as defined by complete radiographic resolution and/or symptoms of pain and gastric outlet obstruction
Time Frame
Baseline to 4 months after initiation of endoscopic treatment
Title
Symptom resolution (Visual Analogue Scale for pain, gastric outlet obstruction, and weight gain)
Time Frame
Baseline to 4 months after initiation of endoscopic treatment
Title
Decrease in incidence of adverse events
Time Frame
Baseline to 4 months after initiation of endoscopic treatment
Title
Decrease in number of hospital days during treatment course
Time Frame
Baseline to 4 months after initiation of endoscopic treatment
Title
Decrease in total costs of pancreatitis-related health care during treatment course
Time Frame
Baseline to 4 months after initiation of endoscopic treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barham Abu Dayyeh, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Endoscopic Large Caliber Drainage vs. Complete Necrosectomy for Treatment of Walled-off Pancreatic Necrosis
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