Esophageal Achalasia
Conditions
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.
Interventions
PROCEDUREPOEM preserving longitudinal muscle
participants are operated POEM only involving circular muscle, leaving longitudinal muscle intact
PROCEDUREPOEM involving longitudinal muscle
participants are operated POEM involving both circular and longitudinal muscle
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactQuan-lin Li, MD
Backup ContactJia-qi Xu, MD
Outcome results
None listed