Per-Oral Endoscopic Myotomy (P.O.E.M.) for Treatment of Esophageal Motility Disorders (POEM)

The Chinese University of Hong Kong

Status: Completed

Conditions: Achalasia; Hypertensive LES

Treatments: Procedure: Per Oral Endoscopic Myotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01525732

CRE-2010_430

Details and patient eligibility

About

Spastic esophageal motility disorders induced significant symptoms including dysphagia, retrosternal pain and regurgitation. Per oral endoscopic myotomy (P.O.E.M.) is a novel approach to perform myotomy through the esophagus with long submucosal tunnel. This study aimed to investigate the feasibility and safety of P.O.E.M. and translate the techniques from animal study to clinical practice in human.

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients with age ranged 18 to 80 who had primary esophageal motility disorders will be recruited. The primary motility disorders included: Achalasia, hypertensive LES, Nutcracker esophagus and Diffuse esophageal spasm.

Exclusion criteria

• Patients will be excluded from this study with the followings -

  1. Pregnancy
  2. Informed consent not available
  3. Previous history of esophagectomy or mediastinal surgery
  4. Previous history of endoscopic resection for early esophageal cancers, including endoscopic mucosal resection and endoscopic submucosal dissection
  5. End-stage Achalasia with dilated esophagus more than 6cm on Barium swallow

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

POEM

Other group

Description:

Per Oral Endoscopic Myotomy

Treatment:

Procedure: Per Oral Endoscopic Myotomy