Per-oral endoscopic submucosal myotomy (POEM) for treatment of achalasia: International multi-center trial

Per-oral endoscopic submucosal myotomy (POEM) for treatment of achalasia: International multi-center trial - POEM

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35807

Enrollment

Registered

2011-07-29

Start date

2011-08-01

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

achalasia benign esophageal stenosis

Interventions

POEM procedures will be conducted as described by Inoue et al. A forward-viewing upper endoscope (GIF 180J) is used with a transparent distal cap attachment. Carbon dioxide gas is necessary for insu

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Patient with symptomatic achalasia and pre-op barium swallow manometry and esophago-gastro-duodenoscopy which are consistent with the diagnosis • Persons of age > 18 years with medical indication for surgical myotomy or endoscopic balloon dilatation • Signed written informed consent.

Exclusion criteria

Exclusion criteria: • Patients with previous surgery of the stomach or esophagus • Patients with known coagulopathy • Previous achalasia-tretament with surgery • Patients with liver cirrhosis and/or esophageal varices • Active esophagitis • Eosinophilic esophagitis • Barrett*s esophagus • Pregnancy • Stricture of the esophagus • Malignant or premalignant esophageal lesion

Design outcomes

Primary

Measure	Time frame
Treatment success defined as successful symptom relief based on an Eckhard score	—

Secondary

Measure	Time frame
• Safety standards, defined as a rate of serious adverse events	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)