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Completed

NCT Number: NCT04154748

Argon Plasma Coagulation for Barrett's Esophagus

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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Key information

Conditions

Barretts Esophagus With Low Grade Dysplasia Barrett Esophagus Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Argon Plasma Coagulation 90W power

Device

Argon Plasma Coagulation 60W power

Device

Omeprazole 120 mg

Drug

Omeprazole 40 MG

Drug

Primary outcomes

  1. 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

Secondary outcomes

  1. Adverse event rate during APC treatment and within 6-week post-treatment period

    Time frame: 6 weeks

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Other

Collaborators

  • Centre of Postgraduate Medical Education

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2015
Study completion
2019
First posted
Nov 6, 2019
Registry last updated
Nov 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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