Peroral endoscopic myotomy: anterior versus posterior approach: a randomized single-blinded clinical trial
| Autor: | Jérôme Rivory, Vivien W. Wong, Philip Wai Yan Chiu, Anthony N. Kalloo, Omid Sanaei, Amr Ismail, Vivek Kumbhari, Mathieu Pioche, Mohamad H. El Zein, Thierry Ponchon, Veena G. Billioux, Hironari Shiwaku, Kumi Ogihara, Nicholas Eleftheriadis, Mouen A. Khashab, Mohammed S. Abusamaan |
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| Rok vydání: | 2019 |
| Předmět: |
Myotomy
Adult Male medicine.medical_specialty Esophageal pH Monitoring SF-36 Manometry medicine.medical_treatment Achalasia 03 medical and health sciences 0302 clinical medicine Postoperative Complications Interquartile range Medicine Humans Radiology Nuclear Medicine and imaging Single-Blind Method Endoscopy Digestive System Aged medicine.diagnostic_test business.industry Gastroenterology Proton Pump Inhibitors Length of Stay Middle Aged medicine.disease Surgery Endoscopy Clinical trial Esophageal Achalasia Treatment Outcome 030220 oncology & carcinogenesis GERD Gastroesophageal Reflux Quality of Life 030211 gastroenterology & hepatology Female business Esophageal pH monitoring Deglutition Disorders |
| Zdroj: | Gastrointestinal endoscopy. 91(2) |
| ISSN: | 1097-6779 0245-4335 |
| Popis: | Background and Aims Peroral endoscopic myotomy (POEM) has become the mainstay for the treatment of achalasia at many institutions around the world since its inception in 2008. POEM can be performed using either the anterior or posterior approach. The primary aim of this study was to compare the efficacy of the anterior and posterior approaches at 1 year after POEM. Methods This is a single-blinded, randomized, noninferiority international clinical trial. Eligible participants were adult patients with a confirmed diagnosis of achalasia via high-resolution esophageal manometry. Patients were randomly allocated with a 1:1 ratio to receive POEM with anterior or posterior approach. The primary aim was to compare the rate of clinical success (Eckardt score Results One hundred fifty patients were randomized to receive either anterior (n = 73) or posterior (n = 77) POEM. One hundred forty-eight patients received the POEM treatment, and 138 patients completed the 1-year follow-up and were included in the primary efficacy analysis. Technical success was achieved in 71 patients (97.3%) in the anterior group versus 77 patients (100%) in the posterior group (P = .23). The median (interquartile range) length of hospital stay after the procedure was 2 (1-3) days for both groups. Adverse events occurred in 15 patients (10%), 8 patients (11%) in the anterior group and 7 patients (9%) in the posterior group (P = .703). Clinical success was achieved in 90% of patients in the anterior group and 89% of patients in the posterior group. Abnormal esophageal acid exposure was detected in 29 of 59 patients (49%) and 25 of 60 patients (42%) in the anterior and posterior groups, respectively (P = .67). GERD questionnaire scores were also not significantly different between the study groups. In both groups, quality of life improved after POEM for all 36-Item Short-Form Health Survey measures and was similar between both groups. Conclusions Posterior myotomy during POEM was not inferior to anterior myotomy in terms of efficacy and safety in the treatment of patients with achalasia. (Clinical trial registration number: NCT02454335.) |
| Databáze: | OpenAIRE |
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