福田 久

BACKGROUND: Symptom scales for achalasia after per-oral endoscopic myotomy (POEM) are lacking. This study aimed to propose a new scale based on the conventional Eckardt score (c-ES) and evaluate persistent symptoms that impair patients' quality of life (QOL) post-POEM. METHODS: Dysphagia, regurgitation, and chest pain frequencies were assessed using a 6-point scale modified-ES (m-ES) after POEM, with "occasional" symptoms on the c-ES further subdivided into three-period categories on m-ES. Symptom severity was further evaluated using a 5-point scale ranging from 1 to 5 points, with a score ≥ 3 points defined as persistent symptoms impairing QOL. We analyzed the correlation between the m-ES and severity score, diagnostic performance of the m-ES for persistent symptoms, and overlaps between each residual symptom. RESULTS: Overall, 536 patients (median follow-up period, 2.9 years) post-POEM were included in this multicenter study. Significant correlations were observed between the m-ES and severity scores for dysphagia (r = 0.67, p < 0.01), regurgitation (r = 0.73, p < 0.01), and chest pain (r = 0.85, p < 0.01). Twenty-six patients (4.9%) had persistent symptoms post-POEM, and 23 of them had m-ES-specific symptom frequency ≥ once a month, which was determined as the optimal frequency threshold for screening persistent symptoms. The total m-ES predicted persistent symptoms more accurately than the total c-ES (area under the curve: 0.95 vs. 0.79, p < 0.01). Furthermore, dysphagia and chest pain were the major residual symptoms post-POEM covering 91.4% of regurgitation. CONCLUSIONS: The new post-POEM scale successfully evaluated the QOL-based patient symptom severities. Our study implied the possibility of a simpler scale using residual dysphagia and chest pain.

Background The pocket-creation method (PCM) has been developed to overcome technical difficulties associated with endoscopic submucosal dissection (ESD), nevertheless, opening of the pocket could still be technically challenging. We developed a novel technique named the PCM with single clip traction (PCM-CT), which utilizes a general-purpose reopenable clip as a traction device to maintain stability during the procedure. To date, no prospective study has compared the efficacy between PCM-CT and the PCM. The aim of this study is to investigate the effectiveness of PCM-CT compared to the PCM in a randomized controlled trial. Methods This randomized controlled clinical trial was conducted at four Japanese institutions. Patients with superficial colorectal neoplastic lesions were included following Japanese guidelines for colorectal cancer. Seven moderately experienced endoscopists performed the ESD procedures using either PCM-CT or PCM. Results A total of 100 patients were enrolled in this study. PCM-CT procedure achieved significant faster dissection speed and reduced the procedure time and pocket-opening time compared to the PCM (27.0±14.5 vs 21.4±10.8 mm2/min, 95% confidence interval (CI) [0.5, 10.7], p=0.031, 64.8±47.6 vs 81.8±57.9 min, 95% CI [-38.2, 4.3], p=0.116, 30.0±28.9 vs 37.8±33.0 min, 95% CI [-20.2, 4.6], p=0.217). En-bloc resection and R0 resection rates were not significantly different between the two groups (100% vs 100%, p=1.000, 100% vs 96%, p=0.495). No significant differences were observed in adverse events between the two groups. Conclusion ESD facilitated by the novel PCM-CT appears to be significantly faster. Additionally, both PCM-CT and PCM achieved high R0 resection rate.