MedTrace Logo

POEM: Long vs Short Myotomy for Achalasia. RCT

NCT03450928 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2018-03-01

No results posted yet for this study

Summary

Per-Oral Endoscopic Myotomy (POEM) is increasingly used for the treatment of achalasia. In published series, a 12cm-POEM is usually performed. Surgical myotomy is typically shorter (8cm). The clinical efficacy of both procedure is comparable.

This study intends to investigate if clinical outcomes of POEM depends on the length of esophageal myotomy, in patients with classic-type achalasia (type I and type II according to Chicago Classification)

Conditions

  • Achalasia

Interventions

PROCEDURE

Peroral Endoscopic Myotomy (POEM)

Peroral endoscopic myotomy (POEM) is a minimally invasive intervention for the treatment of esophageal achalasia. POEM includes different steps: 1. Lifting of the esophageal mucosa, with the injection of saline solution, and mucosal incision on the esophageal body (approximately 12 or 7 cm above the esophagogastric junction, for about 1-2cm) 2. Advance of the endoscope into the submucosa, repeated submucosal injection and dissection of a submucosal tunnel into the distal esophagus up to 3 cm into the gastric wall. 3. Myotomy of the distal esophagus, cardia and gastric wall, starting 3 cm below the mucosal incision 4. After the completion of myotomy, and check for mucosal integrity, the mucosal incision is closed using endoscopic clips

Sponsors & Collaborators

  • Catholic University of the Sacred Heart

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-06
Primary Completion
2020-01-01
Completion
2022-01-01

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03450928 on ClinicalTrials.gov