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Abstract
Objective Peroral endoscopic myotomy (POEM) has become standard treatment for achalasia with comparable efficacy to surgery. In most of published series, the length of myotomy is 12–13 cm. Shorter cuts could have the advantage of shorter procedure time and possibly reduced gastro-oesophageal reflux disease (GORD) rate.
Design This single-centre, patient-blinded, randomised, non-inferiority clinical trial included 200 patients, who were randomly allocated, to receive either a long-POEM (13 cm; 101 patients) or a short-POEM (8 cm; 99 patients). Primary outcome was defined as an Eckardt symptom score of ≤3 at 24 months after the procedure; a non-inferiority design was chosen with an accepted success range of 6% between the two treatments. Secondary outcomes included operating time, complication rate, postoperative manometry, GORD rate and quality of life.
Results In the intention-to-treat analysis, clinical success rates were 89.1% in the long-POEM and 98.0% in the short-POEM group, resulting in an absolute between-group difference of −8.9% (90% CI −14.5 to −3.3).
Procedure time was significantly reduced in the short-POEM as compared with the long-POEM group (40 vs 50 min, p<0.0001). Severe adverse events occurred in one patient in both groups.
No differences were observed in postoperative GORD: acid exposure >6% on pH monitoring study at 6 months was seen in 34.3% (long-POEM) vs 31.1% (short-POEM), while endoscopic oesophagitis was diagnosed in 37.6% vs 51.5% at 6 months and in 21% vs 24.5% at 24 months. Regular proton pump inhibitor use was not different either (36.8% vs 37.5%).
Conclusions Our study demonstrates non-inferiority of a shorter cut length of POEM as compared with the standard treatment, which saved some procedural time. GORD rate was not reduced by reducing cutting length.
Trial registration number NCT03450928.
- achalasia
- therapeutic endoscopy
- lower oesophageal sphincter
- oesophageal disease
- gastroesophageal reflux disease
Data availability statement
Data are available on reasonable request.
Statistics from Altmetric.com
- achalasia
- therapeutic endoscopy
- lower oesophageal sphincter
- oesophageal disease
- gastroesophageal reflux disease
Data availability statement
Data are available on reasonable request.
Footnotes
Twitter @http://www.twitter.com/pietrofamiliari, @ivoboskoski
Contributors PF is the author responsible for this project. He was responsible for study design, running of the study, data analysis, interpretation and write-up of the manuscript. He is responsible for the overall content as the guarantor. FBdA conceived and supervised the study, and contributed to the data acquisition, analysis and interpretation and write-up of the manuscript. RL contributed to the case recruitment, acquisition, analysis and interpretation of data. FM contributed to the case recruitment, acquisition, analysis and interpretation of data and reviewed the work critically for important intellectual content. IB substantially contributed to the design of the study, contributed to the analysis and interpretation of data and reviewed the work critically for important intellectual contents. AT contributed to the acquisition, analysis and interpretation of data for the work and reviewed the manuscript for important intellectual contents. VP contributed to the acquisition, analysis and interpretation of data, and reviewed the manuscript critically for important intellectual contents. GC was an advisor of this project, responsible for overseeing the study, final data analysis, write-up of the manuscript and final manuscript approval. GC is responsible for the overall content as the guarantor.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests PF, FBdA, RL, FM, AT and VP have no conflict of interest or financial ties to disclose. GC is a member of the advisory board of Cook Medical, Olympus and Johnson & Johnson. He received a Research Grant from Boston Scientific and Apollo Endosurgery. IB is a consultant for Apollo Endosurgery, Cook Medical and Boston Scientific. He received a Research Grant from Apollo Endosurgery. He is a member of the scientific board of EndoTools.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
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