Clinical Outcomes of Peroral Endoscopic Myotomy

Clinical Outcomes of Peroral Endoscopic Myotomy for Esophageal Outflow Obstruction

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02989883

Enrollment

Registered

2016-12-12

Start date

2016-10-31

Completion date

2018-09-30

Last updated

2016-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Achalasia

Keywords

achalasia, POEM, outcome

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.

Detailed description

Prospective study

Interventions

OTHERperoral 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
number of patients with Eckardt score <3 after the procedure	1 month after the procedure

Secondary

Measure	Time frame
adverse events which are related to the procedure	within 30 days

Countries

South Korea

Contacts

Primary ContactHwoon-Yong Jung

hyjung@amc.seoul.kr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026