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Comparison Study of Conventional POEM and Hybrid POEM for Esophageal Achalasia

This study is currently recruiting participants.
Verified December 2012 by Shanghai Zhongshan Hospital
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier:
NCT01742494
First received: November 20, 2012
Last updated: December 2, 2012
Last verified: December 2012
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by Shanghai Zhongshan Hospital:

Primary Outcome Measures:
  • Procedure time in both groups [ Time Frame: during POEM procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • clinical efficacy and safety [ Time Frame: during hospital stay and up to 1 year ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01742494

Contacts
Contact: Ping-Hong Zhou, M.D, PhD 86-13681971063 zhou1968@yahoo.cn

Locations
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
Investigators
Study Director: Ping-Hong Zhou, M.D., PhD Fudan University
  More Information

No publications provided

Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT01742494     History of Changes
Other Study ID Numbers: Hybrid POEM
Study First Received: November 20, 2012
Last Updated: December 2, 2012
Health Authority: China: Ethics Committee

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

Additional relevant MeSH terms:
Esophageal Achalasia
Esophageal Diseases
Esophageal Motility Disorders
 Deglutition Disorders
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 18, 2013