Endoscopy 2018; 50(04): S53
DOI: 10.1055/s-0038-1637185
ESGE Days 2018 oral presentations
20.04.2018 – Best abstract awards
Georg Thieme Verlag KG Stuttgart · New York

LONG VS SHORT POEM FOR THE TREATMENT OF ACHALASIA. INTERIM ANALYSIS OF A RANDOMIZED CONTROLLED TRIAL

P Familiari
1   Fondazione Policlinico Agostino Gemelli, Rome, Italy
,
R Landi
1   Fondazione Policlinico Agostino Gemelli, Rome, Italy
,
F Borrelli De Andreis
1   Fondazione Policlinico Agostino Gemelli, Rome, Italy
,
A Calì
1   Fondazione Policlinico Agostino Gemelli, Rome, Italy
,
F Mangiola
1   Fondazione Policlinico Agostino Gemelli, Rome, Italy
,
V Bove
1   Fondazione Policlinico Agostino Gemelli, Rome, Italy
,
F D'Aversa
1   Fondazione Policlinico Agostino Gemelli, Rome, Italy
,
A Costantini
1   Fondazione Policlinico Agostino Gemelli, Rome, Italy
,
I Boskoski
1   Fondazione Policlinico Agostino Gemelli, Rome, Italy
,
A Tringali
1   Fondazione Policlinico Agostino Gemelli, Rome, Italy
,
V Perri
1   Fondazione Policlinico Agostino Gemelli, Rome, Italy
,
G Costamagna
1   Fondazione Policlinico Agostino Gemelli, Rome, Italy
› Author Affiliations
Further Information

Publication History

Publication Date:
27 March 2018 (online)

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    Aims:

    PerOral Endoscopic Myotomy (POEM) is increasingly used for the treatment of achalasia. In published series, a 12 cm-POEM is usually performed. Surgical myotomy is typically shorter (8 cm). We report on the interim analysis of a non-inferiority RCT that evaluates the outcomes according to the length of the myotomy.

    Methods:

    Patients with type I and II achalasia were randomly assigned to one of the two groups, longmyotomy (LM, 12 cm) and shortmyotomy (SM, 7 cm). During followup, manometry, pHmonitoring study and EGD were performed; symptoms and quality of life (QOL) were assessed with Eckardt score (ECKs) and SF-36. Study outcomes were clinical success (ECKs < 4), variation of LES pressure, procedure time, complication- and GERD-rate. Calculated sample size was 200 patients.

    Results:

    Between 2014 and July 2017, 147 patients were enrolled; 120 patients (58 in the LM and 62 in the SMgroup) with a minimum 6-month follow-up were included in this interim analysis. Baseline demographics, manometric and preoperative characteristics were similar in both groups. POEM was technically successful in all the cases. Procedure time was significantly longer in the LMgroup compared to the SMgroup (54.8'± 17.3’ vs. 43.6'± 17.0’, p = 0.0001). At 6-month follow-up, clinical success (98% in LM- and 100% in SM-group), LES pressure (19.6 ± 11.1 mmHg vs. 16.1 ± 10.1 mmHg, p = 0.085), 4sIRP (8.7 ± 4.8 mmHg vs. 7.8 ± 5.3 mmHg, p = 0.369) and prevalence of GERD (33.9% vs. 35.0%, p = 0.714) were similar in both groups. Overall incidence of mild adverse events (25,3% vs. 28,5%) and moderate or severe complications (0,8% vs. 0%) was similar in LM- and SM-group, respectively. A significant, similar QOL improvement was detected in both groups after POEM.

    Conclusions:

    This study demonstrates the safety and the efficacy of the investigational technique (SM) which, with the limits of an interim analysis, is not inferior to conventional LM.


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