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Argon Plasma Coagulation for Barrett's Esophagus

NCT04154748 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2019-11-19

No results posted yet for this study

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.

Conditions

  • Barretts Esophagus With Low Grade Dysplasia

Interventions

DEVICE

Argon Plasma Coagulation 90W power

DEVICE

Argon Plasma Coagulation 60W power

DRUG

Omeprazole 120 mg

DRUG

Omeprazole 40 mg

Sponsors & Collaborators

  • Centre of Postgraduate Medical Education

    collaborator OTHER

  • Maria Sklodowska-Curie National Research Institute of Oncology

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-06-04
Primary Completion
2015-02-10
Completion
2019-07-05

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04154748 on ClinicalTrials.gov