Snare-assisted POEM for Treatment of Esophageal Achalasia

NCT ID: NCT02999451

Last Updated: 2020-06-30

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2019-12-31

Brief Summary

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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 Description

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Conditions

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Esophageal Achalasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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snare group

snare-assisted POEM

Group Type EXPERIMENTAL

snare-assisted POEM

Intervention Type DEVICE

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

Group Type ACTIVE_COMPARATOR

knife-assisted POEM

Intervention Type DEVICE

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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age between 18-70 years
* Diagnosed as achalasia base on high resolution manometry, barium esophagram and Upper endoscopy
* Signed written informed consent

Exclusion Criteria

* ASA class \> Ⅲ
* Previous endoscopic or surgical treatment for achalasia
* Esophageal malignancy
* Pregnant
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Xiangbin Xing

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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China

Other Identifiers

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123

Identifier Type: -

Identifier Source: org_study_id

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