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Clinical Outcomes of Peroral Endoscopic Myotomy

Primary Purpose

Achalasia

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

peroral endoscopic myotomy

About this trial

This is an interventional treatment trial for Achalasia focused on measuring achalasia, POEM, outcome

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Peroral endoscopic myotomy (POEM)

Arm Description

Patients who received POEM

Outcomes

Primary Outcome Measures

number of patients with Eckardt score <3 after the procedure

Secondary Outcome Measures

adverse events which are related to the procedure

Full Information

NCT ID

NCT02989883

First Posted

December 4, 2016

Last Updated

December 8, 2016

Sponsor

Asan Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02989883

Brief Title

Clinical Outcomes of Peroral Endoscopic Myotomy

Official Title

Clinical Outcomes of Peroral Endoscopic Myotomy for Esophageal Outflow Obstruction

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Unknown status

Study Start Date

October 2016 (undefined)

Primary Completion Date

March 2018 (Anticipated)

Study Completion Date

September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Asan Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Prospective study

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Achalasia

Keywords

achalasia, POEM, outcome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Peroral endoscopic myotomy (POEM)

Arm Type

Other

Arm Description

Patients who received POEM

Intervention Type

Other

Intervention Name(s)

peroral endoscopic myotomy

Intervention Description

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.

Primary Outcome Measure Information:

Title

number of patients with Eckardt score <3 after the procedure

Time Frame

1 month after the procedure

Secondary Outcome Measure Information:

Title

adverse events which are related to the procedure

Time Frame

within 30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hwoon-Yong Jung

hyjung@amc.seoul.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hwoon-Yong Jung

Organizational Affiliation

Asan Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Seoul

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

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

hyjung@amc.seoul.kr

First Name & Middle Initial & Last Name & Degree

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

First Name & Middle Initial & Last Name & Degree

Do Hoon Kim, M.D.

First Name & Middle Initial & Last Name & Degree

Kee Don Choi, M.D., PhD.

First Name & Middle Initial & Last Name & Degree

Ji Yong Ahn, M.D., PhD.

First Name & Middle Initial & Last Name & Degree

Eun Jeong Gong, M.D.

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34115014

Citation

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.

Results Reference

derived

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Clinical Outcomes of Peroral Endoscopic Myotomy

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