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Clinical Outcomes of Peroral Endoscopic Myotomy

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ClinicalTrials.gov Identifier: NCT02989883
Recruitment Status : Unknown
Verified December 2016 by Hwoon-Yong Jung, Asan Medical Center.
Recruitment status was:  Recruiting
First Posted : December 12, 2016
Last Update Posted : December 12, 2016
Sponsor:
Information provided by (Responsible Party):
Hwoon-Yong Jung, Asan Medical Center

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 Not Applicable

Detailed Description:
Prospective study

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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 : October 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. number of patients with Eckardt score <3 after the procedure [ Time Frame: 1 month after the procedure ]

Secondary Outcome Measures :
  1. adverse events which are related to the procedure [ Time Frame: within 30 days ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02989883


Contacts
Contact: Hwoon-Yong Jung hyjung@amc.seoul.kr

Locations
Korea, Republic of
Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Hwoon-Yong Jung, M.D., PhD.       hyjung@amc.seoul.kr   
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.         
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Hwoon-Yong Jung Asan Medical Center

Responsible Party: Hwoon-Yong Jung, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02989883     History of Changes
Other Study ID Numbers: 2016-0999
First Posted: December 12, 2016    Key Record Dates
Last Update Posted: December 12, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hwoon-Yong Jung, Asan Medical Center:
achalasia
POEM
outcome

Additional relevant MeSH terms:
Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases