NCT02999451

Snare-assisted POEM for Treatment of Esophageal Achalasia

Safety, Efficacy and Cost-effectiveness of Snare-assisted POEM for Treatment of Esophageal Achalasia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: First Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophageal Achalasia

Interventions

Type	Name	Description
DEVICE	snare-assisted POEM	POEM is performed by using a snare which is retracted into the sheath to expose the tip, leaving a 1-2mm length for operation. 1. After submucosal injection, an initial 2-cm mucosal incision is made by a snare in the posterior esophageal wall. 2. A submucosal tunnel from the esophagus to the gastric cardia is created using a snare. 3. Full-thickness myotomy is performed and extended 2-3 cm beyond the esophagogastric junction (EGJ) using a snare. 4. The mucosal incision is closed with endoclips.
DEVICE	knife-assisted POEM	POEM is performed by using a conventional endoscopic knife. 1. After submucosal injection, an initial 2-cm mucosal incision is made by a knife in the posterior esophageal wall. 2. A submucosal tunnel from the esophagus to the gastric cardia is created using a knife. 3. Full-thickness myotomy is performed and extended 2-3 cm beyond the esophagogastric junction (EGJ) using a knife. 4. The mucosal incision is closed with endoclips.

Timeline

• Start date: 2017-05-01
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2016-12-21
• Last updated: 2020-06-30

Locations

1 site across 1 country: China