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

Not Applicable

• Conditions: Esophageal Achalasia
• Interventions: Procedure: POEM involving longitudinal muscle; Procedure: POEM preserving longitudinal muscle

• Registration Number: NCT03733756
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-11
• Study First Submitted: 2018-11-06
• Study First Submitted QC: 2018-11-06
• Study First Posted: 2018-11-07
• Last Update Submitted: 2018-11-11
• Last Update Posted: 2018-11-14
• Study Start: 2019-01-01
• Primary Completion: 2020-06-30
• Study Completion: 2020-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 308

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
POEM involving longitudinal muscle	POEM involving longitudinal muscle	participants are operated POEM involving the whole layer of muscle, both circular and longitudinal muscle
POEM preserving longitudinal muscle	POEM preserving longitudinal muscle	participants are operated POEM only involving circular muscle, leaving longitudinal muscle intact

Primary Outcome Measures

Name	Time	Method
efficacy of POEM treatment	4 weeks after POEM	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.

Secondary Outcome Measures

Name	Time	Method
complications(GERD) of POEM treatment	4 weeks after POEM	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.

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China