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Completed

NCT Number: NCT01525732

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

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.

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Key information

Conditions

Achalasia Deglutition Disorders Digestive System Diseases Esophageal Achalasia Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases Hypertensive LES

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chinese University of Hong Kong

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Per Oral Endoscopic Myotomy

Procedure

Primary outcomes

  1. Dysphagia score before and after P.O.E.M.

    Time frame: From 1st day after POEM to within 2 weeks after POEM

Secondary outcomes

  1. Eckardt score before and after P.O.E.M.

    Time frame: Before and 1 month after POEM

  2. Post-operative pain

    Time frame: From Day 1 to until 2 weeks after POEM

  3. Operative time

    Time frame: Up to 24 hours

  4. Hospital stay

    Time frame: From day of admission till up to 30 days

  5. Perioperative complication

    Time frame: 30 days after operation

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Acronym: POEM

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Feb 3, 2012
Registry last updated
May 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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