Prospective Study on the Feasibility and Effectiveness of Per-Oral Endoscopic Myotomy (P.O.E.M.) for Treatment of Primary Esophageal Motility Disorders

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01524458

Acronym

POEM

Enrollment

Registered

2012-02-02

Start date

2010-07-31

Completion date

Unknown

Last updated

2012-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Esophageal Motility Disorders Including Achalasia and Hypertensive LES

Brief summary

rimary spastic esophageal motility disorders, though uncommon, induce significant symptoms to patients including dysphagia, spastic chest pain, regurgitation as well as heartburn. The commonest causes of spastic esophageal motility disorders included Achalasia, hypertensive lower esophageal sphincter (LES), Nutcracker esophagus and Diffuse esophageal spasm (DES). Majority of these diseases were diagnosed by manometry. Achalasia is the most common primary esophageal motility disorder in which the LES failed to relax with increased pressure. Currently the standard treatment for Achalasia and spastic motility disorders is Laparoscopic Myotomy. The development of Natural Orifices Transluminal Endoscopic Surgery (N.O.T.E.S.) has lead to a new way to perform myotomy - Peroral Endoscopic Myotomy (P.O.E.M.). Basically, through mucosal incision, a submucosal tunnel is created after identification of the level of gastroesophageal junction. Myotomy will be performed with endoscopic instruments and the entrance site will be closed with clips.

Interventions

PROCEDUREPer-Oral Endoscopic Myotomy

To perform myotomy for lower esophageal sphincter using endoscope through a long submucosal tunnel

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

* All patients with age ranged 18 to 85 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

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, inclduing endoscopic mucosal resection and endsocopic submucosal dissection 5. End-stage Achalasia with dilated esophagus more than 6cm on Barium swllow

Design outcomes

Primary

Measure	Time frame
Relief of Dysphagia	4 weeks

Secondary

Measure	Time frame
Complication	30 days

Countries

China

Contacts

Primary ContactPhilip WY Chiu, MD

philipchiu@surgery.cuhk.edu.hk85226322627

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026