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NCT Number: NCT02518542

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Contraindication for EGD

Treatment and study plan

Endoscopic intervention A

Procedure

POEM: Per oral endoscopic myotomy

Endoscopic intervention B

Procedure

PRD: Prolonged dilatation by temporary implantation of large diameter stent . Stents are additionally attached to the esophageal wall by different technical options.

Endoscopic intervention C

Procedure

Endoscopic balloon dilatation

Laparoscopic surgery

Procedure

Laparoscopic Heller myotomy

Primary outcomes

  1. Achalasia specific symptoms according to the Eckardt score (0-12)

    Time frame: 6 mo post-op

    Eckardt score: Weight loss 0kg (0), less than 5kg (1), 5-10 kg (2), more than 10 kg (3); Dysphagia none(0), occasional (1), daily (2), every meal (3); Regurgitation none(0), occasional (1), daily (2), every meal (3); Retrosternal pain none(0), occasional (1), daily (2), every meal (3)

Secondary outcomes

  1. Barium column height (cm) in esophagogram

    Time frame: 6 mo post-op

  2. Resting pressure (mmHg) at the lower esophageal sphincter

    Time frame: 6 mo post-op

  3. Stent migration

    Time frame: p.o. day 1

    Analysis: On the first postoperative day a routine esophagogram will be used to evaluate the appropriate location of the esophageal stent. Early distal stent dislocation/migration into the stomach will be registered.

  4. Percent of time (min)/24h that the pH is less than 4.0 in pH-metry

    Time frame: 6 mo post-op

Study contacts

Contact information is provided by the study sponsor or research team.

Department of Surgery, Medical University of Vienna

CONTACT

[email protected]; [email protected]

+43 1 40400 ext. 5621

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Per Oral Endoscopic Myotomy (POEM) and Prolonged Dilatation (PRD) as Additional Endoscopic Treatment Options for Achalasia and Other Esophageal Motility Disorders

Acronym: POETA

Important dates

Study start
2014
Primary completion
2024
Study completion
2027
First posted
Aug 10, 2015
Registry last updated
Aug 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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