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Endoscopic Ultrasound-guided Drainage of Walled Off Necrosis (WON)

Primary Purpose

Pancreatic Pseudocyst

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lumen-apposing metal stent (LAMS)
Double pigtail plastic stent (DPPS)
Sponsored by
Yiqi Du
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Pseudocyst

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject with ages from 18-80 years old
  2. Subject with pancreatic pseudocysts confirmed by CT
  3. Subject with a history of MSAP or SAP, the pseudocysts were formed more than 3 months
  4. The size of pseudocyst is more than 6 cm, and the cyst adjacent to the gastric wall
  5. Subject has the symptoms related with the pseudocyst
  6. The consent form has been signed

Exclusion Criteria:

  1. Subject is younger than 18 years or older than 80 years
  2. Pancreatic pseudocyst communicate with the main pancreatic duct
  3. Subject can't accept the endoscopic procedure
  4. Pancreatic pseudocyst with infection or subject diagnosed with pancreatic abscess
  5. The distance between gastric and the wall of the pseudocyst is more than 1 cm
  6. Subject with 2 or more than 2 cysts
  7. Subject has blood coagulation dysfunction
  8. Pregnant or subject has mental disorders

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Lumen-apposing metal stent(LAMS)

    Double pigtail plastic stent(DPPS)

    Arm Description

    Lumen-apposing metal stent(LAMS) will be deployed by endoscopist under the guidance of EUS

    Double pigtail plastic stent(DPPS) will be deployed by endoscopist under the guidance of EUS

    Outcomes

    Primary Outcome Measures

    clinical success
    The cysts completely disappeared, or diameter ≤ 2cm in the imaging follow-up symptoms have eased

    Secondary Outcome Measures

    adverse event
    any adverse event occured after stent inserted
    recurrence rate
    After the clinical success, imaging examination show cyst again and accompanied by symptoms
    technical success
    Stent placed through the wall bracket and pancreatic pseudocyst successfully

    Full Information

    First Posted
    January 14, 2017
    Last Updated
    March 28, 2018
    Sponsor
    Yiqi Du
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03027895
    Brief Title
    Endoscopic Ultrasound-guided Drainage of Walled Off Necrosis (WON)
    Official Title
    Endoscopic Ultrasound-guided Drainage of Walled Off Necrosis (WON)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2018 (Anticipated)
    Primary Completion Date
    September 2019 (Anticipated)
    Study Completion Date
    September 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Yiqi Du

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to compare the effect of lumen-apposing metal stent (LAMS) and double pigtail plastic stents (DPPSs) on the drainage of pancreatic walled-off necrosis (WON), mainly to observe the efficacy and safety of LAMS for WON.
    Detailed Description
    Patient with pancreatic walled-off necrosis (WON) would be treated randomized with lumen-apposing metal stent (LAMS) or double pigtail plastic stents (DPPSs) under the guidance of Endoscopic Ultrasonography. The investigators compare the effect of the two stents, including technical success, clinical success, adverse event, recurrence, and so on.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pancreatic Pseudocyst

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    256 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Lumen-apposing metal stent(LAMS)
    Arm Type
    Experimental
    Arm Description
    Lumen-apposing metal stent(LAMS) will be deployed by endoscopist under the guidance of EUS
    Arm Title
    Double pigtail plastic stent(DPPS)
    Arm Type
    Active Comparator
    Arm Description
    Double pigtail plastic stent(DPPS) will be deployed by endoscopist under the guidance of EUS
    Intervention Type
    Device
    Intervention Name(s)
    Lumen-apposing metal stent (LAMS)
    Intervention Description
    Endoscopic Ultrasound-guided Drainage of WON with LAMS
    Intervention Type
    Device
    Intervention Name(s)
    Double pigtail plastic stent (DPPS)
    Intervention Description
    Endoscopic Ultrasound-guided Drainage of WON with DPPS
    Primary Outcome Measure Information:
    Title
    clinical success
    Description
    The cysts completely disappeared, or diameter ≤ 2cm in the imaging follow-up symptoms have eased
    Time Frame
    uo to 1 months
    Secondary Outcome Measure Information:
    Title
    adverse event
    Description
    any adverse event occured after stent inserted
    Time Frame
    up to 2months/ stent remove
    Title
    recurrence rate
    Description
    After the clinical success, imaging examination show cyst again and accompanied by symptoms
    Time Frame
    up to 12 months
    Title
    technical success
    Description
    Stent placed through the wall bracket and pancreatic pseudocyst successfully
    Time Frame
    up to 48 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subject with ages from 18-80 years old Subject with pancreatic pseudocysts confirmed by CT Subject with a history of MSAP or SAP, the pseudocysts were formed more than 3 months The size of pseudocyst is more than 6 cm, and the cyst adjacent to the gastric wall Subject has the symptoms related with the pseudocyst The consent form has been signed Exclusion Criteria: Subject is younger than 18 years or older than 80 years Pancreatic pseudocyst communicate with the main pancreatic duct Subject can't accept the endoscopic procedure Pancreatic pseudocyst with infection or subject diagnosed with pancreatic abscess The distance between gastric and the wall of the pseudocyst is more than 1 cm Subject with 2 or more than 2 cysts Subject has blood coagulation dysfunction Pregnant or subject has mental disorders

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30305160
    Citation
    Zhu HY, Xie P, Song YX, Li ZS, Jin ZD, Du YQ. Lumen-apposing metal stents (LAMS) versus plastic stents for EUS-guided drainage of walled-off necrosis (WON) (LVPWON): study protocol for a multicenter randomized controlled trial. Trials. 2018 Oct 11;19(1):549. doi: 10.1186/s13063-018-2901-3.
    Results Reference
    derived

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    Endoscopic Ultrasound-guided Drainage of Walled Off Necrosis (WON)

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