Peroral endoscopic myotomy for idiopathic achalasia: randomized comparison of water-jet assisted versus conventional dissection technique.
BACKGROUND
Peroral endoscopic myotomy (POEM) has recently been introduced as a promising alternative to laparoscopic Heller myotomy for idiopathic achalasia. Several proposed technical modifications are yet to be tested in randomized trials.


OBJECTIVE
The objective of our study was to evaluate efficacy and safety of water-jet (WJ) assisted POEM versus the conventional (C) technique. The clinical trial registration number is NCT01742494.


METHODS
A prospective randomized trial was carried out in Zhongshan Hospital, Fudan University (Shanghai, China), in 100 consenting achalasia patients between August 2011 and April 2012. Patients eligible for POEM were randomized to use of either the HybridKnife (WJ group) or the conventional technique using injection and triangle tip knife interchangeably (C group).


RESULTS
A total of 100 patients with comparable characteristics between groups were included. Procedure time was significantly shorter for the WJ group (22.9 ± 6.7 vs. 35.9 ± 11.7 min; p < 0.0001), mostly due to less replacement of accessories (2.0 ± 2.4 vs. 19.2 ± 7.6; p < 0.0001). Injection volume was larger in the WJ group (45.3 ± 10.2 vs. 35.2 ± 9.5 ml; p < 0.0001) and was associated with fewer minor bleeding episodes (3.6 ± 1.8 vs. 6.8 ± 5.2; p < 0.0001). No severe complications occurred; one case of cutaneous emphysema occurred in the WJ group, and four cases occurred in the C group (p = 0.17), three cases of pneumonia were encountered in the C group and none in the WJ group (p = 0.24). Treatment success (Eckardt score ≤3) was achieved in 96.5 % of patients, with no significant differences between groups.


CONCLUSIONS
The use of the HybridKnife leads to a significant decrease in POEM procedure time and facilitates reinjection, possibly contributing to a lower rate of minor intra-procedural bleeding.
Ming-Yan
MY
Cai
Ping-Hong
PH
Zhou
Li-Qing
LQ
Yao
Mei-Dong
MD
Xu
Yun-Shi
YS
Zhong
Quan-Lin
QL
Li
Wei-Feng
WF
Chen
Jian-Wei
JW
Hu
Zhao
Z
Cui
Bo-Qun
BQ
Zhu
D000293:Adolescent; D000328:Adult; D000368:Aged; D004210:Dissection / Q000379:methods*; D016099:Endoscopy, Gastrointestinal / Q000379:methods*; D004931:Esophageal Achalasia / Q000601:surgery*; D004947:Esophagus / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009055:Mouth; D057605:Natural Orifice Endoscopic Surgery / Q000379:methods*; D011446:Prospective Studies; D016896:Treatment Outcome; D014867:Water; D055815:Young Adult
D014867:Water