Clinical Outcomes of Peroral Endoscopic Myotomy

NCT02989883 | Unknown DMC

• 1 other identifier: 2016-0999
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Achalasia

Keywords

achalasia; POEM; outcome

Outcome Measures

Primary Outcomes (1)

• number of patients with Eckardt score <3 after the procedure

  1 month after the procedure

Secondary Outcomes (1)

• adverse events which are related to the procedure

  within 30 days

Study Arms (1)

Peroral endoscopic myotomy (POEM)

OTHER

Patients who received POEM

Other: peroral endoscopic myotomy

Interventions

peroral endoscopic myotomy OTHER

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.

Peroral endoscopic myotomy (POEM)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who were diagnosed as esophageal outflow obstruction
• Patients with informed consent

You may not qualify if:

• Diagnostic uncertainty
• Patients who are not suitable for general anesthesia

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

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

Seoul, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 34115014 DERIVED

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Hwoon-Yong Jung

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hwoon-Yong Jung

CONTACT

hyjung@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 4, 2016
• First Posted: December 12, 2016
• Study Start: October 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: September 1, 2018
• Last Updated: December 12, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)