Clinical Outcomes of Peroral Endoscopic Myotomy

• Sponsor: Asan Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02989883
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 23
• Patients Per Site Per Month: 0.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Achalasia	Other: peroral endoscopic myotomy	N/A

Detailed Description

Prospective study

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Outcomes of Peroral Endoscopic Myotomy for Esophageal Outflow Obstruction
• Study Start Date: Oct 1, 2016
• Anticipated Primary Completion Date: Mar 1, 2018
• Anticipated Study Completion Date: Sep 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. number of patients with Eckardt score <3 after the procedure [1 month after the procedure]

Secondary Outcome Measures

1. adverse events which are related to the procedure [within 30 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Asan Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hwoon-Yong Jung, Professor, Asan Medical Center
• ClinicalTrials.gov Identifier: NCT02989883
• Other Study ID Numbers: 2016-0999
• First Posted: Dec 12, 2016
• Last Update Posted: Dec 12, 2016
• Last Verified: Dec 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Hwoon-Yong Jung, Professor, Asan Medical Center: achalasia; POEM; outcome
• Additional relevant MeSH terms: Esophageal Achalasia

Study Results

No Results Posted as of Dec 12, 2016