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Comparison Study of Conventional POEM and Hybrid POEM for Esophageal Achalasia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by Shanghai Zhongshan Hospital.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital Identifier:
First received: November 20, 2012
Last updated: December 2, 2012
Last verified: December 2012
Peroral endoscopic myotomy (POEM) has recently been introduced as promising alternative to laparoscopic Heller myotomy for patients with idiopathic achalasia. Several technical modifications have been proposed but have not yet been tested in randomized trials.

Condition Intervention
Esophageal Achalasia
Procedure: Water-jet POEM
Procedure: Conventional POEM

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Peroral Endoscopic Myotomy for Esophageal Achalasia: Randomized Comparison of Water-Jet Assisted Versus Conventional Dissection Technique

Resource links provided by NLM:

Further study details as provided by Shanghai Zhongshan Hospital:

Primary Outcome Measures:
  • Procedure time in both groups [ Time Frame: during POEM procedure ]

Secondary Outcome Measures:
  • clinical efficacy and safety [ Time Frame: during hospital stay and up to 1 year ]
    bleeding complications, pneumothorax or pleural effusion requiring intervention

Other Outcome Measures:
  • Therapeutic success [ Time Frame: Every 3 months after innitial intervention via telephone questionnaires during follow-up up to 1 year ]
    a reduction in the Eckardt score to ≤3

Estimated Enrollment: 100
Study Start Date: August 2011
Estimated Study Completion Date: December 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Water-jet POEM
POEM were performed by the use of Erbe Hybrid knife (WJ group)
Procedure: Water-jet POEM
Water-jet assisted POEM procedure was performed
Active Comparator: Conventional POEM
POEM were performed by the conventional technique using injection and triangle tip knife (C group).
Procedure: Conventional POEM
POEM were performed by the use of conventional technique using injection and triangle tip knife.

Detailed Description:

Objective: To evaluate efficacy and safety of water-jet assisted POEM (WJ) versus the conventional technique (C).

Interventions: Patients with achalasia diagnosed by symptoms, endoscopy and barium swallow eligible for POEM were randomized to either the use of Erbe Hybrid knife (WJ group) or the conventional technique using injection and triangle tip knife interchangeably (C group).

Main outcome measurements: Procedure time in both groups; secondary outcomes were clinical efficacy and safety (bleeding complications, pneumothorax or pleural effusion requiring intervention)


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • With an Eckardt symptom score ≥ 4
  • The diagnosis of achalasia was made on the basis of the absence of peristalsis and on impaired relaxation of the LES on established methods (barium swallow, manometry, esophagogastroduodenoscopy)
  • Informed patient consent was obtained

Exclusion Criteria:

  • Severe cardiopulmonary disease or other serious disease leading to unacceptable surgical risk
  • Pseudoachalasia
  • Megaesophagus (diameter of > 7 cm)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01742494

Contact: Ping-Hong Zhou, M.D, PhD 86-13681971063

China, Shanghai
Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Principal Investigator: Ping-Hong Zhou, MD,PhD         
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Study Director: Ping-Hong Zhou, M.D., PhD Fudan University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Shanghai Zhongshan Hospital Identifier: NCT01742494     History of Changes
Other Study ID Numbers: Hybrid POEM
Study First Received: November 20, 2012
Last Updated: December 2, 2012

Keywords provided by Shanghai Zhongshan Hospital:
Esophageal Achalasia,
Peroral endoscopic myotomy,
Water-jet assisted

Additional relevant MeSH terms:
Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases processed this record on May 25, 2017