Clinical Trial: Snare-assisted POEM for Treatment of Esophageal Achalasia
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Safety,Efficacy and Cost-effectiveness of Snare-assisted POEM for Treatment of Esophageal Achalasia
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.
Detailed Summary:
Sponsor: First Affiliated Hospital, Sun Yat-Sen University
Current Primary Outcome:
- Number of participants with treatment-related adverse events including mucosal perforation, subcutaneous emphysema, pneumoperitoneum, pneumothorax, pneumomediastinum, pleural effusion, and pneumonia [ Time Frame: 1 year ]
- 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.
Original Primary Outcome: Same as current
Current Secondary Outcome: Cost of POEM treatment in participants [ Time Frame: 1 year ]
Original Secondary Outcome: Same as current
Information By: First Affiliated Hospital, Sun Yat-Sen University
Dates:
Date Received: November 29, 2016
Date Started: January 2017
Date Completion: December 2018
Last Updated: December 20, 2016
Last Verified: December 2016
