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

ConditionEsophageal Achalasia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of Vienna

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Contraindication for EGD

Trial design

Design model

Parallel

Treatments tested in this trial

  • Endoscopic intervention A

    Procedure/Surgery

    POEM: Per oral endoscopic myotomy

  • Endoscopic intervention B

    Procedure/Surgery

    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/Surgery

    Endoscopic balloon dilatation

  • Laparoscopic Surgery

    Procedure/Surgery

    Laparoscopic Heller myotomy

Treatment groups

400 Participants
are divided into 4 treatment groups
Group A: Per oral endoscopic therapy AActive comparator 1 intervention
Group B: Per oral endoscopic therapy BActive comparator 1 intervention
Group C: Per oral endoscopic therapy CActive comparator 1 intervention
Group D: Laparoscopic surgeryActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

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)

Time frame
6 mo post-op

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

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.

Time frame
p.o. day 1
4

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

Time frame
6 mo post-op

Other outcomes

Sponsors and contacts

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Medical University of Vienna

Lead sponsor

Source ClinicalTrials.gov
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