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Snare-assisted POEM for Treatment of Esophageal Achalasia

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ClinicalTrials.gov Identifier: NCT02999451
Recruitment Status : Unknown
Verified December 2016 by Xiangbin Xing, First Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was:  Not yet recruiting
First Posted : December 21, 2016
Last Update Posted : December 21, 2016
Sponsor:
Information provided by (Responsible Party):
Xiangbin Xing, First Affiliated Hospital, Sun Yat-Sen University

Brief Summary:
POEM is a new intervention for the treatment of achalasia and has been reported to relieve the dysphagia symptom effectively. Although the cost of POEM method is less than the method of Laparoscopic Heller Myotomy and Fundoplication, it is still of an economic burden for the patients with achalasia. In this trial, investigators plan to use snare to assist POEM procedure, to observe the safety, efficacy and cost-effectiveness of this method, compared with other knifes-assisted procedure.

Condition or disease Intervention/treatment Phase
Esophageal Achalasia Device: snare-assisted POEM Device: knife-assisted POEM Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety,Efficacy and Cost-effectiveness of Snare-assisted POEM for Treatment of Esophageal Achalasia
Study Start Date : January 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: snare
snare-assisted POEM
Device: snare-assisted POEM
POEM was performed by using snare in place of common knives

knife
knife-assisted POEM
Device: knife-assisted POEM
POEM was performed by using common knives




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events including mucosal perforation, subcutaneous emphysema, pneumoperitoneum, pneumothorax, pneumomediastinum, pleural effusion, and pneumonia [ Time Frame: 1 year ]
  2. The changes of Eckardt score of participants posterior to POEM treatment [ Time Frame: 1 year ]

    Eckardt score assessment was made as reported in reference[1].

    [1] Eckardt AJ, Eckardt VF. Treatment and surveillance strategies in achalasia: an update. Nat Rev Gastroenterol Hepatol. 2011;8(6):311-9.



Secondary Outcome Measures :
  1. Cost of POEM treatment in participants [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18-70 year; diagnosed as achalasia according to upper GI endoscopy, upper GI barium meal,and esophageal manometry;

Exclusion Criteria:

  • severe lung, heart, liver or renal disease; carcinoma; pregnant; accepted treatment of POEM, Laparoscopic Heller Myotomy or dilation before

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Responsible Party: Xiangbin Xing, MD,phD, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02999451     History of Changes
Other Study ID Numbers: 123
First Posted: December 21, 2016    Key Record Dates
Last Update Posted: December 21, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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