Clinical trial NCT03733756: to Explore the Influence of Longitudinal Muscle on the Prognosis of Achalasia Patients After Peroral Endoscopic Myotomy (POEM)
Official title: to Explore the Influence of Longitudinal Muscle on the Prognosis of Achalasia Patients After Peroral Endoscopic Myotomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Achalasia
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2018-11-07
Enrollment: 308
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Achalasia is a disease characterized by lack of peristalsis and lower esophageal sphincter failing to relax. Longitudinal muscle, outer layer of esophageal smooth muscle, is recently found to be responsible for emptying of esophagus for achalasia patients, especially for those type Ⅱcases. Clinical observations also conclude that type Ⅱ achalasia which still preserve longitudinal muscle response best to treatment, among the 3 types. Thus, with high frequent intraluminal ultrasound, clinically applied as endoscopic ultrasound, to measure the function of longitudinal muscle in achalasia patients, the current research aims to explore the influence of longitudinal muscle on the prognosis of achalasia patients after peroral endoscopic myotomy, a routine treatment.


Eligibility criteria: Inclusion Criteria:

* Diagnosed of esophageal achalasia
* Patients or legal surrogates willing and competent to give informed consent

Exclusion Criteria:

* postoperative or post-POEM
* post-pneumatic dilation or post-stenting
* fail to go through high frequency intraluminal ultrasound （HFIUS)
* Patients with American Society of Anesthesiologists （ASA） score ≥3

Primary outcomes:
measure: efficacy of POEM treatment
timeFrame: 4 weeks after POEM
Secondary outcomes:
measure: complications(GERD) of POEM treatment
timeFrame: 4 weeks after POEM
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Zhongshan Hospital, Fudan University, Shanghai, China
name: Ping-Hong Zhou, MD,PhD
role: STUDY_CHAIR
References:
citation: Hong SJ, Bhargava V, Jiang Y, Denboer D, Mittal RK. A unique esophageal motor pattern that involves longitudinal muscles is responsible for emptying in achalasia esophagus. Gastroenterology. 2010 Jul;139(1):102-11. doi: 10.1053/j.gastro.2010.03.058. Epub 2010 Apr 8.
citation: Schoeman MN, Holloway RH. Secondary oesophageal peristalsis in patients with non-obstructive dysphagia. Gut. 1994 Nov;35(11):1523-8. doi: 10.1136/gut.35.11.1523.
citation: Liu ZQ, Li QL, Chen WF, Zhang XC, Wu QN, Cai MY, Qin WZ, Hu JW, Zhang YQ, Xu MD, Yao LQ, Zhou PH. The effect of prior treatment on clinical outcomes in patients with achalasia undergoing peroral endoscopic myotomy. Endoscopy. 2019 Apr;51(4):307-316. doi: 10.1055/a-0658-5783. Epub 2018 Sep 27.
citation: Mittal RK, Liu J, Puckett JL, Bhalla V, Bhargava V, Tipnis N, Kassab G. Sensory and motor function of the esophagus: lessons from ultrasound imaging. Gastroenterology. 2005 Feb;128(2):487-97. doi: 10.1053/j.gastro.2004.08.004.