Peroral endoscopic myotomy: anterior versus posterior approach: a randomized single-blinded clinical trial

Mouen Khashab, Omid Sanaei, Jerome Rivory, Nicholas Eleftheriadis, Philip Wai Philip, Hironari Shiwaku, Kumi Ogihara, Amr Ismail, Mohammed S. Abusamaan, Mohamad H. El Zein, Vivien W. Wong, Veena G. Billioux, Vivek Kumbhari, Anthony N Kalloo, Thierry Ponchon, Mathieu Pioche

Research output: Contribution to journalArticle

Abstract

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 <3) of anterior and posterior approaches at 1 year. 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.)

Original languageEnglish (US)
JournalGastrointestinal endoscopy
DOIs
StateAccepted/In press - Jan 1 2019

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Clinical Trials
Esophageal Achalasia
Length of Stay
Pyridinolcarbamate
Manometry
Gastroesophageal Reflux
Health Surveys
Therapeutics
Quality of Life
Safety
Acids

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Gastroenterology

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Peroral endoscopic myotomy : anterior versus posterior approach: a randomized single-blinded clinical trial. / Khashab, Mouen; Sanaei, Omid; Rivory, Jerome; Eleftheriadis, Nicholas; Philip, Philip Wai; Shiwaku, Hironari; Ogihara, Kumi; Ismail, Amr; Abusamaan, Mohammed S.; El Zein, Mohamad H.; Wong, Vivien W.; Billioux, Veena G.; Kumbhari, Vivek; Kalloo, Anthony N; Ponchon, Thierry; Pioche, Mathieu.

In: Gastrointestinal endoscopy, 01.01.2019.

Research output: Contribution to journalArticle

Khashab, M, Sanaei, O, Rivory, J, Eleftheriadis, N, Philip, PW, Shiwaku, H, Ogihara, K, Ismail, A, Abusamaan, MS, El Zein, MH, Wong, VW, Billioux, VG, Kumbhari, V, Kalloo, AN, Ponchon, T & Pioche, M 2019, 'Peroral endoscopic myotomy: anterior versus posterior approach: a randomized single-blinded clinical trial', Gastrointestinal endoscopy. https://doi.org/10.1016/j.gie.2019.07.034
Khashab, Mouen ; Sanaei, Omid ; Rivory, Jerome ; Eleftheriadis, Nicholas ; Philip, Philip Wai ; Shiwaku, Hironari ; Ogihara, Kumi ; Ismail, Amr ; Abusamaan, Mohammed S. ; El Zein, Mohamad H. ; Wong, Vivien W. ; Billioux, Veena G. ; Kumbhari, Vivek ; Kalloo, Anthony N ; Ponchon, Thierry ; Pioche, Mathieu. / Peroral endoscopic myotomy : anterior versus posterior approach: a randomized single-blinded clinical trial. In: Gastrointestinal endoscopy. 2019.
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abstract = "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 <3) of anterior and posterior approaches at 1 year. 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.)",
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AU - Khashab, Mouen

AU - Sanaei, Omid

AU - Rivory, Jerome

AU - Eleftheriadis, Nicholas

AU - Philip, Philip Wai

AU - Shiwaku, Hironari

AU - Ogihara, Kumi

AU - Ismail, Amr

AU - Abusamaan, Mohammed S.

AU - El Zein, Mohamad H.

AU - Wong, Vivien W.

AU - Billioux, Veena G.

AU - Kumbhari, Vivek

AU - Kalloo, Anthony N

AU - Ponchon, Thierry

AU - Pioche, Mathieu

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N2 - 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 <3) of anterior and posterior approaches at 1 year. 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.)

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