Barrett Esophagus, Esophageal Adenocarcinoma, Reflux Disease
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREEndoscopic radiofrequency ablation
Endoscopic ablation technique for Barrett's epithelium
PROCEDUREEndoscopic hybrid argon plasma coagulation
Endoscopic ablation technique for Barrett's epithelium
Sponsors
Maria Sklodowska-Curie National Research Institute of Oncology
Centre of Postgraduate Medical Education
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of post-procedural pain | 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. |
| Level of post-procedural pain at day 7 after treatment | 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) |
| Level of late post-procedural pain (at day 30 after treatment) | 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
| Measure | Time frame | Description |
|---|---|---|
| Level of post-procedural dysphagia | 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) |
| Level of post-procedural quality of life | 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). |
| The rate of complications | 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). |
Countries
Poland
Outcome results
None listed