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Endoscopic 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Withdrawn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
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Necrotizing Pancreatitis focused on measuring Acute Necrotizing Pancreatitis, Walled-Off Pancreatic Necrosis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 29, 2015
    Last Updated
    April 17, 2019
    Sponsor
    Mayo Clinic
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    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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