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Comparison Study of Conventional POEM and Hybrid POEM for Esophageal Achalasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01742494
Recruitment Status : Unknown
Verified December 2012 by Shanghai Zhongshan Hospital.
Recruitment status was:  Recruiting
First Posted : December 5, 2012
Last Update Posted : December 5, 2012
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Esophageal Achalasia Procedure: Water-jet POEM Procedure: Conventional POEM Not Applicable

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)

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Peroral Endoscopic Myotomy for Esophageal Achalasia: Randomized Comparison of Water-Jet Assisted Versus Conventional Dissection Technique
Study Start Date : August 2011
Actual Primary Completion Date : April 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arms and Interventions
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Arm Intervention/treatment
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.


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

Secondary Outcome Measures :
  1. 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:
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01742494


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

Locations
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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
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Study Director: Ping-Hong Zhou, M.D., PhD Fudan University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT01742494    
Other Study ID Numbers: Hybrid POEM
First Posted: December 5, 2012    Key Record Dates
Last Update Posted: December 5, 2012
Last Verified: December 2012
Keywords provided by Shanghai Zhongshan Hospital:
Esophageal Achalasia,
Peroral endoscopic myotomy,
Water-jet assisted
Additional relevant MeSH terms:
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Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases