to Explore the Influence of Longitudinal Muscle on the Prognosis of Achalasia Patients After Peroral Endoscopic Myotomy (POEM)

Study Overview
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Brief Summary
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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.

Official Title
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to Explore the Influence of Longitudinal Muscle on the Prognosis of Achalasia Patients After Peroral Endoscopic Myotomy

Conditions
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Esophageal Achalasia

Intervention / Treatment
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* Procedure: POEM preserving longitudinal muscle
* Procedure: POEM involving longitudinal muscle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: POEM preserving longitudinal muscle<br>participants are operated POEM only involving circular muscle, leaving longitudinal muscle intact | Procedure: POEM preserving longitudinal muscle<br>* participants are operated POEM only involving circular muscle, leaving longitudinal muscle intact<br>|
| Active Comparator: POEM involving longitudinal muscle<br>participants are operated POEM involving the whole layer of muscle, both circular and longitudinal muscle | Procedure: POEM involving longitudinal muscle<br>* participants are operated POEM involving both circular and longitudinal muscle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of POEM treatment | Eckardt score ≤3; Eckardt scale includes 4 items: dysphagia, weight loss, poststernal pain and esophageal reflux, each item ranging from 0-3. The higher the score reaches, the more severe the disease is. It is considered to be efficient if the Eckardt score is ≤3 after POEM. | 4 weeks after POEM | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications(GERD) of POEM treatment | gastroesophageal reflux disease questionnaire （GERD-Q） score≥2; GERD-Q scale includes 4 items: post-sternal pain, esophageal reflux, proton pump inhibitor applied, endoscopy identified, each item scoring 0 or 1. The higher the score reaches, the more likely the patient has GERD. It is considered to have a complication as GERD if the GERD-Q ≥2. | 4 weeks after POEM |