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Argon Plasma Coagulation for Barrett's Esophagus

Primary Purpose

Barretts Esophagus With Low Grade Dysplasia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Argon Plasma Coagulation 90W power
Argon Plasma Coagulation 60W power
Omeprazole 120 mg
Omeprazole 40 mg
Sponsored by
Maria Sklodowska-Curie National Research Institute of Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Barretts Esophagus With Low Grade Dysplasia focused on measuring Barretts Esophagus, Dysplasia, Argon Plasma Coagulation, Endoscopic Treatment

Eligibility Criteria

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

Inclusion Criteria:

  • consecutive adult patients with low-grade dysplasia in flat Barrett's mucosa referred for endoscopic treatment,
  • signed an informed consent to participate in the study.

Exclusion Criteria:

  • high-grade dysplasia or adenocarcinoma,
  • visible lesions (nodules, ulcerations) in Barrett's mucosa,
  • serious comorbidities and short life expectancy,
  • coagulopathy,
  • pregnancy or lactation,
  • psychiatric disorders.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    APC 90W / PPI 120mg

    APC 90W / PPI 40mg

    APC 60 W/ PPI 120mg

    Arm Description

    treatment with high-power argon plasma coagulation (90 Watt) followed by acid suppression with high-dose oral omeprazole (40 mg t.i.d)

    treatment with high-power argon plasma coagulation (90 Watt) followed by acid suppression with standard dose oral omeprazole (40 mg q.d)

    treatment with standard-power argon plasma coagulation (60 Watt) followed by acid suppression with high-dose oral omeprazole (40 mg t.i.d)

    Outcomes

    Primary Outcome Measures

    Complete ablation rate 6 weeks after APC treatment.
    Complete ablation was defined as no endoscopic and histologic evidence of Barrett's mucosa, dysplasia, and buried metaplastic glands

    Secondary Outcome Measures

    Adverse event rate during APC treatment and within 6-week post-treatment period
    Complete ablation rate two years after APC treatment
    Complete ablation was defined as no endoscopic and histologic evidence of Barrett's mucosa, dysplasia, and buried metaplastic glands
    Complete ablation rate at the end of follow-up
    Complete ablation was defined as no endoscopic and histologic evidence of Barrett's mucosa, dysplasia, and buried metaplastic glands

    Full Information

    First Posted
    November 5, 2019
    Last Updated
    November 15, 2019
    Sponsor
    Maria Sklodowska-Curie National Research Institute of Oncology
    Collaborators
    Centre of Postgraduate Medical Education
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04154748
    Brief Title
    Argon Plasma Coagulation for Barrett's Esophagus
    Official Title
    Argon Plasma Coagulation for Barrett's Esophagus With Low Grade Dysplasia: A Randomized Trial With Long Term Follow-up Evaluating the Impact of Power Setting and Proton Pump Inhibitor Dose
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    June 4, 2002 (Actual)
    Primary Completion Date
    February 10, 2015 (Actual)
    Study Completion Date
    July 5, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Maria Sklodowska-Curie National Research Institute of Oncology
    Collaborators
    Centre of Postgraduate Medical Education

    4. Oversight

    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Background and study aims. To evaluate the impact of power setting and proton pump inhibitor (PPI) dose on the efficacy and safety of argon plasma coagulation (APC) of Barrett's esophagus (BE) with low-grade dysplasia (LGD). Patients and methods. Investigator initiated, single-center, parallel-group randomized controlled trial (RCT) conducted in a tertiary referral center in Poland. Consecutive patients with BE and LGD were randomly assigned to APC with power set at 90 Watt (90W) or 60 Watt (60W) followed by 120 mg or 40 mg omeprazole for six weeks. The primary outcome of the study was the rate of complete (endoscopic and histologic) ablation of BE at six weeks. Secondary outcomes included safety and long-term efficacy (at two years and at the end of a long-term follow-up of over 4 years.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Barretts Esophagus With Low Grade Dysplasia
    Keywords
    Barretts Esophagus, Dysplasia, Argon Plasma Coagulation, Endoscopic Treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Investigator initiated, single-center, parallel-group RCT conducted in a tertiary referral center in Poland.
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    Patients were blinded to the power settings used for APC, but they knew the PPI dose they received. The endoscopist performing APC ablation was blinded to participant allocation and APC power setting (the power was set up by an assistant who knew the group allocation and the power display remained covered during the entire procedure). The endoscopist and pathologist involved in efficacy assessment were blinded to participant allocation.
    Allocation
    Randomized
    Enrollment
    71 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    APC 90W / PPI 120mg
    Arm Type
    Experimental
    Arm Description
    treatment with high-power argon plasma coagulation (90 Watt) followed by acid suppression with high-dose oral omeprazole (40 mg t.i.d)
    Arm Title
    APC 90W / PPI 40mg
    Arm Type
    Active Comparator
    Arm Description
    treatment with high-power argon plasma coagulation (90 Watt) followed by acid suppression with standard dose oral omeprazole (40 mg q.d)
    Arm Title
    APC 60 W/ PPI 120mg
    Arm Type
    Active Comparator
    Arm Description
    treatment with standard-power argon plasma coagulation (60 Watt) followed by acid suppression with high-dose oral omeprazole (40 mg t.i.d)
    Intervention Type
    Device
    Intervention Name(s)
    Argon Plasma Coagulation 90W power
    Intervention Type
    Device
    Intervention Name(s)
    Argon Plasma Coagulation 60W power
    Intervention Type
    Drug
    Intervention Name(s)
    Omeprazole 120 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Omeprazole 40 mg
    Primary Outcome Measure Information:
    Title
    Complete ablation rate 6 weeks after APC treatment.
    Description
    Complete ablation was defined as no endoscopic and histologic evidence of Barrett's mucosa, dysplasia, and buried metaplastic glands
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Adverse event rate during APC treatment and within 6-week post-treatment period
    Time Frame
    6 weeks
    Title
    Complete ablation rate two years after APC treatment
    Description
    Complete ablation was defined as no endoscopic and histologic evidence of Barrett's mucosa, dysplasia, and buried metaplastic glands
    Time Frame
    2 years
    Title
    Complete ablation rate at the end of follow-up
    Description
    Complete ablation was defined as no endoscopic and histologic evidence of Barrett's mucosa, dysplasia, and buried metaplastic glands
    Time Frame
    Long term follow-up (>4 yars)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: consecutive adult patients with low-grade dysplasia in flat Barrett's mucosa referred for endoscopic treatment, signed an informed consent to participate in the study. Exclusion Criteria: high-grade dysplasia or adenocarcinoma, visible lesions (nodules, ulcerations) in Barrett's mucosa, serious comorbidities and short life expectancy, coagulopathy, pregnancy or lactation, psychiatric disorders.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32650347
    Citation
    Wronska E, Polkowski M, Orlowska J, Mroz A, Wieszczy P, Regula J. Argon plasma coagulation for Barrett's esophagus with low-grade dysplasia: a randomized trial with long-term follow-up on the impact of power setting and proton pump inhibitor dose. Endoscopy. 2021 Feb;53(2):123-132. doi: 10.1055/a-1203-5930. Epub 2020 Jul 10. Erratum In: Endoscopy. 2020 Oct 01;:
    Results Reference
    derived

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    Argon Plasma Coagulation for Barrett's Esophagus

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