Snare-assisted POEM for Treatment of Esophageal Achalasia

Sun Yat-sen University

Status: Completed

Conditions: Esophageal Achalasia

Treatments: Device: snare-assisted POEM; Device: knife-assisted POEM

Study type: Interventional

Funder types: Other

Identifiers

NCT02999451

123

Details and patient eligibility

About

POEM is a new intervention for the treatment of achalasia and has been reported to relieve the dysphagia symptom effectively. Although the cost of POEM method is less than the method of Laparoscopic Heller Myotomy and Fundoplication, it is still of an economic burden for the patients with achalasia. In this trial, investigators plan to use snare to assist POEM procedure, to observe the safety, efficacy and cost-effectiveness of this method, compared with other knifes-assisted procedure.

Enrollment: 75 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18-70 years
• Diagnosed as achalasia base on high resolution manometry, barium esophagram and Upper endoscopy
• Signed written informed consent

Exclusion criteria

• ASA class > Ⅲ
• Previous endoscopic or surgical treatment for achalasia
• Esophageal malignancy
• Pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

snare group

Experimental group

Description:

snare-assisted POEM

Treatment:

Device: snare-assisted POEM

conventional group

Active Comparator group

Description:

knife-assisted POEM

Treatment:

Device: knife-assisted POEM