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Clinical Outcomes of Peroral Endoscopic Myotomy

NCT ID: NCT02989883

Last Updated: 2016-12-12

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-09-30

Brief Summary

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Esophageal outflow obstruction is characterized by failure to relax the lower esophageal sphincter (LES), resulting in impaired flow of ingested food into the stomach. The subsequent stasis of ingested food leads to symptoms of dysphagia, regurgitation, chest pain, and weight loss. The core objective of the treatment of esophageal outflow obstruction is to disrupt the LES and reduce its pressure to allow esophageal emptying. Therapeutic options include pharmacologic therapy, Botulinum toxin injection, pneumatic balloon dilation, and surgical myotomy with partial fundoplication. In addition, peroral endoscopy myotomy (POEM) has recently been introduced as a minimally invasive treatment, but there have a few studies regarding long-term outcomes. The aim of this study is to evaluate clinical outcomes of POEM for esophageal outflow obstruction.

Detailed Description

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Prospective study

Conditions

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Achalasia

Keywords

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achalasia POEM outcome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Peroral endoscopic myotomy (POEM)

Patients who received POEM

Group Type OTHER

peroral endoscopic myotomy

Intervention Type OTHER

The procedure consists of four steps: 1) mucosal incision 10-15 cm above the esophagogastric junction to allow entry into the submucosa, 2) creation of a submucosal tunnel until the lower esophageal sphincter is reached, 3) myotomy of the circular muscle layer, and 4) closure of the mucosal entry with endoclips.

Interventions

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peroral endoscopic myotomy

The procedure consists of four steps: 1) mucosal incision 10-15 cm above the esophagogastric junction to allow entry into the submucosa, 2) creation of a submucosal tunnel until the lower esophageal sphincter is reached, 3) myotomy of the circular muscle layer, and 4) closure of the mucosal entry with endoclips.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients who were diagnosed as esophageal outflow obstruction
* Patients with informed consent

Exclusion Criteria

* Diagnostic uncertainty
* Patients who are not suitable for general anesthesia
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Hwoon-Yong Jung

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hwoon-Yong Jung

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hwoon-Yong Jung

Role: CONTACT

Email: [email protected]

Facility Contacts

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Hwoon-Yong Jung, M.D., PhD.

Role: primary

References

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Gong EJ, Na HK, Ahn JY, Jung KW, Kim DH, Choi KD, Song HJ, Jung HY. Prospective evaluation of the efficacy of peroral endoscopic myotomy in patients with achalasia. Medicine (Baltimore). 2021 Jun 11;100(23):e26248. doi: 10.1097/MD.0000000000026248.

Reference Type DERIVED
PMID: 34115014 (View on PubMed)

Other Identifiers

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2016-0999

Identifier Type: -

Identifier Source: org_study_id