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Snare-assisted POEM for Treatment of Esophageal Achalasia

NCT02999451 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2020-06-30

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • First Affiliated Hospital, Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Xiangbin Xing, MD, PhD · First Affiliated Hospital, Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02999451 on ClinicalTrials.gov