Per Oral Endoscopic Myotomy (POEM) and Prolonged Dilatation (PRD) for Achalasia (POETA)

Medical University of Vienna

Status: Enrolling

Conditions: Esophageal Achalasia

Treatments: Procedure: Endoscopic intervention A; Procedure: Endoscopic intervention B; Procedure: Endoscopic intervention C; Procedure: Laparoscopic Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02518542

POETA

Details and patient eligibility

About

Achalasia is an esophageal motility disorder, which leads to clinical symptoms such as dysphagia, regurgitation, chest pain and consecutive weight loss.

Although conventional treatment such as laparoscopic Heller myotomy (LHM) and balloon dilatation (BD) can provide sufficient symptom relief in many patients, both interventions have their individual drawbacks. Additionally, treatment after failed LHM or BD can be challenging and in few might even lead to esophagectomy.

Per oral endoscopic myotomy (POEM) and prolonged dilatation (PRD) are two novel endoscopically performed therapeutic options for achalasia and other esophageal motility disorders. Both not only appear to provide good results, when performed as initial treatment but also might be an excellent option after e.g failed LHM.

The purpose of this study is to evaluate the long-term efficacy of four different treatment options, such as POEM, PRD with stent-fixation, PD and conventional LHM for achalasia in an individualized treatment setting.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of achalsia, hypertensive lower esophageal sphincter, nutcracker esophagus, or diffuse esophageal spasm

Exclusion criteria

• Contraindication for EGD

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 4 patient groups

Per oral endoscopic therapy A

Active Comparator group

Description:

Per oral endoscopic myotomy

Treatment:

Procedure: Endoscopic intervention A

Per oral endoscopic therapy B

Active Comparator group

Description:

Prolonged dilatation by implantation of large diameter stents.

Treatment:

Procedure: Endoscopic intervention B

Per oral endoscopic therapy C

Active Comparator group

Description:

Dilatation

Treatment:

Procedure: Endoscopic intervention C

Laparoscopic surgery

Active Comparator group

Description:

Laparoscopic Heller myotomy

Treatment:

Procedure: Laparoscopic Surgery