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Completed

NCT Number: NCT05051475

Endoscopic Radiofrequency Ablation Versus Hybrid Argon Plasma Coagulation in the Treatment of Barrett's Esophagus

This study compares patients' acceptability and safety of two established endoscopic methods for treating dysplastic Barrett's esophagus: radiofrequency ablation versus hybrid argon plasma coagulation.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Centre for Postgraduate Education

Warsaw, 02-781, Poland

About this study

Both endoscopic radiofrequency ablation (RFA) and argon plasma coagulation (APC) are established treatment modalities for dysplastic Barrett's esophagus. Recently, a modification of the APC method has emerged, which involves a submucosal injection of saline preceding the thermal ablation (hybrid-APC; h-APC). This allows to increase the procedure's safety and presumably reduces the patients' post-procedural discomfort. Although both RFA and h-APC are characterized by high effectiveness in eradicating Barrett's segments, limited data compares the patient-related aspects of the procedures. To fill this knowledge gap, we set out a single-center randomized-controlled trial to compare procedural acceptability, safety, and impact on the quality of life, of the two methods.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female subjects over 18 years
  • Histologically and endoscopically proven Barrett's esophagus requiring ablation therapy according to the current guidelines
  • General health status sufficient to perform an endoscopic procedure (ASA I-III)

Exclusion criteria

  • Primary or secondary coagulopathy, with INR>1.5 and/or platelet count of <75,000.
  • Anticoagulation therapy (e.g. warfarin) for high-risk condition and unable to withhold the medication temporarily
  • Recent myocardial infraction or other significant cardiovascular event within 6 months prior to recruitment
  • Patients under long-term care and/or within nursing facilities (e.g. psychosocial disorders, mental retardation)
  • Any history of esophageal resection surgery
  • Esophageal varices

Treatment and study plan

Endoscopic radiofrequency ablation

Procedure

Endoscopic ablation technique for Barrett's epithelium

Endoscopic hybrid argon plasma coagulation

Procedure

Endoscopic ablation technique for Barrett's epithelium

Primary outcomes

  1. Level of post-procedural pain

    Time frame: Measured at any time point before given anesthesia for the procedure and immidietly after the procedure.

    Change in chest pain evaluated by the numeric analog scale (NAS) from score 0 (no pain) to 10 (worst possible pain) before the procedure and immidietly after (30-60 minutes) the procedure.

  2. Level of post-procedural pain at day 7 after treatment

    Time frame: Measured at day 7 after the procedure

    Post-procedural chest pain evaluated by the numeric analog scale (NAS) from score 0 (no pain) to 10 (worst possible pain)

  3. Level of late post-procedural pain (at day 30 after treatment)

    Time frame: Measured at day 30 after the procedure

    Post-procedural chest pain evaluated by the numeric analog scale (NAS) from score 0 (no pain) to 10 (worst possible pain)

Secondary outcomes

  1. Level of post-procedural dysphagia

    Time frame: Measured before the procedure, immidietly after (30-60mins), and at day 7, and day 30 after the procedure.

    Evaluated by the Mellow-Pinkas scoring from 0 (able to eat normal diet / no dysphagia) to 4 (unable to swallow anything / total dysphagia)

  2. Level of post-procedural quality of life

    Time frame: Measured before the procedure, immidietly after (30-60mins), and at day 7, and day 30 after the procedure.

    Evaluated by the QLQ-OES18 questionnaire specific for esophageal symptoms, and consists of a symptom scale only. The QLQ-OES18 includes 18 questions: 6 single item subscales relating to saliva swallowing, choking, dry mouth, taste, coughing, and talking. It also includes 12 items grouped into 4 subscales: dysphagia (3 items), eating (4 items), reflux (2 items), and pain (3 items).

  3. The rate of complications

    Time frame: Measured during the prcoedure, immidietly after the procedure and at day 7 and day 30 after the procedure during follow-up

    Intra-procedural complications, such as bleeding, perforation, post-procedural complications, e.g. chest-pain, esophageal stricture will be monitored during the hospital stay and follow-up at day 7 and day 30 after the procedure (phone call).

Sponsors and collaborators

Lead sponsor

Centre of Postgraduate Medical Education

Other

Collaborators

  • Maria Sklodowska-Curie National Research Institute of Oncology

Registry information

Official study title

Endoscopic Radiofrequency Ablation Versus Hybrid Argon Plasma Coagulation in the Treatment of Barrett's Esophagus - the Patients' Perspective: a Randomized Controlled Trial Assessing Procedural Acceptability and Safety (RATE Study)

Acronym: RATE

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Sep 21, 2021
Registry last updated
Oct 3, 2025

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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