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

Fudan University

Status: Unknown

Conditions: Esophageal Achalasia

Treatments: Procedure: POEM preserving longitudinal muscle; Procedure: POEM involving longitudinal muscle

Study type: Interventional

Funder types: Other

Identifiers

NCT03733756

LM for achalasia

Details and patient eligibility

About

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.

Enrollment: 308 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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308 participants in 2 patient groups

POEM preserving longitudinal muscle

Experimental group

Description:

participants are operated POEM only involving circular muscle, leaving longitudinal muscle intact

Treatment:

Procedure: POEM preserving longitudinal muscle

POEM involving longitudinal muscle

Active Comparator group

Description:

participants are operated POEM involving the whole layer of muscle, both circular and longitudinal muscle

Treatment:

Procedure: POEM involving longitudinal muscle