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

被引:41
|
作者
Khashab, Mouen A. [1 ]
Sanaei, Omid [1 ]
Rivory, Jerome [2 ]
Eleftheriadis, Nicholas [3 ,4 ]
Chiu, Philip Wai Yan [5 ]
Shiwaku, Hironari [6 ]
Ogihara, Kumi [7 ]
Ismail, Amr [1 ]
Abusamaan, Mohammed S. [8 ]
El Zein, Mohamad H. [1 ]
Wong, Vivien W. [5 ]
Billioux, Veena G. [9 ]
Kumbhari, Vivek [1 ]
Kalloo, Anthony N. [1 ]
Ponchon, Thierry [2 ]
Pioche, Mathieu [2 ]
机构
[1] Johns Hopkins Med Inst, Div Gastroenterol & Hepatol, Baltimore, MD 21205 USA
[2] Hop Edouard Herriot, Endoscopy & Gastroenterol Unit, Lyon, France
[3] Metropolitan Hosp Athens, Gastroenterol Unit, Endoscopy Dept, Athens, Greece
[4] Aristotle Univ Thessaloniki, Med Sch, Thessaloniki, Greece
[5] Chinese Univ Hong Kong, Dept Surg, Div Upper GI & Metab Surg, Shatin, Hong Kong, Peoples R China
[6] Fukuoka Univ, Fac Med, Dept Surg Gastroenterol, Fukuoka, Japan
[7] Nagazaki Univ Hosp, Dept Gastroenterol & Hepatol, Nagazaki, Japan
[8] Johns Hopkins Med Inst, Div Gen Internal Med, Baltimore, MD 21205 USA
[9] Johns Hopkins Univ, Sch Med, Bayview Pediat, Baltimore, MD USA
关键词
LAPAROSCOPIC HELLER MYOTOMY; POEM; ACHALASIA; OUTCOMES; NONINFERIORITY; LHM;
D O I
10.1016/j.gie.2019.07.034
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
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 scoreswere 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.
引用
收藏
页码:288 / +
页数:17
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