Argon Plasma Coagulation for Barrett's Esophagus

November 15, 2019 updated by: Maria Sklodowska-Curie National Research Institute of Oncology

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: APC 90W / PPI 120mg
treatment with high-power argon plasma coagulation (90 Watt) followed by acid suppression with high-dose oral omeprazole (40 mg t.i.d)
Device: Argon Plasma Coagulation 90W power
Drug: Omeprazole 120 mg
ACTIVE_COMPARATOR: APC 90W / PPI 40mg
treatment with high-power argon plasma coagulation (90 Watt) followed by acid suppression with standard dose oral omeprazole (40 mg q.d)
Device: Argon Plasma Coagulation 90W power
Drug: Omeprazole 40 mg
ACTIVE_COMPARATOR: APC 60 W/ PPI 120mg
treatment with standard-power argon plasma coagulation (60 Watt) followed by acid suppression with high-dose oral omeprazole (40 mg t.i.d)
Drug: Omeprazole 120 mg
Device: Argon Plasma Coagulation 60W power

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse event rate during APC treatment and within 6-week post-treatment period
Time Frame: 6 weeks
6 weeks
Complete ablation rate two years after APC treatment
Time Frame: 2 years
Complete ablation was defined as no endoscopic and histologic evidence of Barrett's mucosa, dysplasia, and buried metaplastic glands
2 years
Complete ablation rate at the end of follow-up
Time Frame: Long term follow-up (>4 yars)
Complete ablation was defined as no endoscopic and histologic evidence of Barrett's mucosa, dysplasia, and buried metaplastic glands
Long term follow-up (>4 yars)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Collaborators

Centre of Postgraduate Medical Education

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 4, 2002

Primary Completion (ACTUAL)

February 10, 2015

Study Completion (ACTUAL)

July 5, 2019

Study Registration Dates

First Submitted

November 5, 2019

First Submitted That Met QC Criteria

November 5, 2019

First Posted (ACTUAL)

November 6, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 19, 2019

Last Update Submitted That Met QC Criteria

November 15, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0102

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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