Argon Plasma Coagulation for Barrett's Esophagus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-04

Study Completion Date

2019-07-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Barretts Esophagus With Low Grade Dysplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Investigator initiated, single-center, parallel-group RCT conducted in a tertiary referral center in Poland.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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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)

Group Type EXPERIMENTAL

Argon Plasma Coagulation 90W power

Intervention Type DEVICE

Omeprazole 120 mg

Intervention Type DRUG

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)

Group Type ACTIVE_COMPARATOR

Argon Plasma Coagulation 90W power

Intervention Type DEVICE

Omeprazole 40 mg

Intervention Type DRUG

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)

Group Type ACTIVE_COMPARATOR

Argon Plasma Coagulation 60W power

Intervention Type DEVICE

Omeprazole 120 mg

Intervention Type DRUG

Interventions

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Argon Plasma Coagulation 90W power

Intervention Type DEVICE

Argon Plasma Coagulation 60W power

Intervention Type DEVICE

Omeprazole 120 mg

Intervention Type DRUG

Omeprazole 40 mg

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No