Clinical Outcomes of Peroral Endoscopic Myotomy

Achalasia Clinical Trial

Official title:

Clinical Outcomes of Peroral Endoscopic Myotomy for Esophageal Outflow Obstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02989883
• Other study ID #: 2016-0999
• 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

• Achalasia
• Esophageal Achalasia

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