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| Name | Class |
|---|---|
| Maria Sklodowska-Curie National Research Institute of Oncology | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| radiofrequency ablation | Active Comparator | Circumferential ablation with radiofrequency ablation will be performed for each segment of the BE starting from the proximal end with one ablation at 12J/cm2, followed by cleaning of mucosal slough with esophageal cap, patient extubation, cleaning of ablation device with wet gauze, and finally a second ablation at 12 J/cm2 (1 × 12J/cm2-clean-1 × 12 J/cm2). Focal ablations will be performed with three consecutive ablations at 12 J/cm2 without cleaning (simplified protocol). |
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| hybrid argon plasma coagulation | Active Comparator | Patients in the Hybrid argon plasma coagulation group will be treated with a single ablation per session with a power limitation of 60 W (pulsed mode (VIO® 300 D & APC 2, PULSED APC®, Effect 2). No scraping with the endoscope cap and second ablation will be performed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic radiofrequency ablation | Procedure | Endoscopic ablation technique for Barrett's epithelium |
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| Measure | Description | Time Frame |
|---|---|---|
| Level of post-procedural pain | 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. | Measured at any time point before given anesthesia for the procedure and immidietly after the procedure. |
| Level of post-procedural pain at day 7 after treatment | Post-procedural chest pain evaluated by the numeric analog scale (NAS) from score 0 (no pain) to 10 (worst possible pain) | Measured at day 7 after the procedure |
| Level of late post-procedural pain (at day 30 after treatment) | Post-procedural chest pain evaluated by the numeric analog scale (NAS) from score 0 (no pain) to 10 (worst possible pain) | Measured at day 30 after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Level of post-procedural dysphagia | Evaluated by the Mellow-Pinkas scoring from 0 (able to eat normal diet / no dysphagia) to 4 (unable to swallow anything / total dysphagia) | Measured before the procedure, immidietly after (30-60mins), and at day 7, and day 30 after the procedure. |
| Level of post-procedural quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wladyslaw Januszewicz, MD | Centre for Postgraduate Medical Education | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Centre for Postgraduate Education | Warsaw | 02-781 | Poland |
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| Endoscopic hybrid argon plasma coagulation | Procedure | Endoscopic ablation technique for Barrett's epithelium |
|
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). |
| Measured before the procedure, immidietly after (30-60mins), and at day 7, and day 30 after the procedure. |
| The rate of complications | 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). | Measured during the prcoedure, immidietly after the procedure and at day 7 and day 30 after the procedure during follow-up |
| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| C562730 | Adenocarcinoma Of Esophagus |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
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