Clinical Outcomes of Peroral Endoscopic Myotomy

December 8, 2016 updated by: Hwoon-Yong Jung, Asan Medical Center

Clinical Outcomes of Peroral Endoscopic Myotomy for Esophageal Outflow Obstruction

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Prospective study

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center
        • Contact:
        • Principal Investigator:
          • Hwoon-Yong Jung, M.D., PhD.
        • Sub-Investigator:
          • Do Hoon Kim, M.D.
        • Sub-Investigator:
          • Kee Don Choi, M.D., PhD.
        • Sub-Investigator:
          • Ji Yong Ahn, M.D., PhD.
        • Sub-Investigator:
          • Eun Jeong Gong, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Peroral endoscopic myotomy (POEM)
Patients who received POEM
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of patients with Eckardt score <3 after the procedure
Time Frame: 1 month after the procedure
1 month after the procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
adverse events which are related to the procedure
Time Frame: within 30 days
within 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Hwoon-Yong Jung, Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

December 4, 2016

First Submitted That Met QC Criteria

December 8, 2016

First Posted (Estimate)

December 12, 2016

Study Record Updates

Last Update Posted (Estimate)

December 12, 2016

Last Update Submitted That Met QC Criteria

December 8, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-0999

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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