Snare-assisted POEM for Treatment of Esophageal Achalasia
NCT ID: NCT02999451
Last Updated: 2020-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
75 participants
INTERVENTIONAL
2017-05-01
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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snare group
snare-assisted POEM
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.
conventional group
knife-assisted POEM
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed as achalasia base on high resolution manometry, barium esophagram and Upper endoscopy
* Signed written informed consent
Exclusion Criteria
* Previous endoscopic or surgical treatment for achalasia
* Esophageal malignancy
* Pregnant
18 Years
70 Years
ALL
No
Sponsors
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First Affiliated Hospital, Sun Yat-Sen University
OTHER
Responsible Party
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Xiangbin Xing
MD, PhD
Principal Investigators
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Xiangbin Xing, MD, PhD
Role: STUDY_DIRECTOR
First Affiliated Hospital, Sun Yat-Sen University
Locations
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First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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123
Identifier Type: -
Identifier Source: org_study_id
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