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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02989883
Other study ID # 2016-0999
Secondary ID
Status Recruiting
Phase N/A
First received December 4, 2016
Last updated December 8, 2016
Start date October 2016
Est. completion date September 2018

Study information

Verified date December 2016
Source Asan Medical Center
Contact Hwoon-Yong Jung
Email hyjung@amc.seoul.kr
Is FDA regulated No
Health authority Korea: Asan Medical Center
Study type Interventional

Clinical Trial 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.


Description:

Prospective study


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date September 2018
Est. primary completion date March 2018
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Korea, Republic of Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary number of patients with Eckardt score <3 after the procedure 1 month after the procedure No
Secondary adverse events which are related to the procedure within 30 days No
See also
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