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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
62
Endoscopic ablation technique for Barrett's epithelium
Endoscopic ablation technique for Barrett's epithelium
Medical Centre for Postgraduate Education
Warsaw, Poland
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.
Time frame: 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)
Time frame: 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)
Time frame: Measured at day 30 after the procedure
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)
Time frame: 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
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).
Time frame: Measured before the procedure, immidietly after (30-60mins), and at day 7, and day 30 after the procedure.
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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).
Time frame: Measured during the prcoedure, immidietly after the procedure and at day 7 and day 30 after the procedure during follow-up