Per Oral Endoscopic Myotomy (POEM) and Prolonged Dilatation (PRD) for Achalasia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endoscopic intervention A, Endoscopic intervention B, Endoscopic intervention C, Laparoscopic Surgery.
- Who it may be relevant to
- Registry conditions: Esophageal Achalasia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Per Oral Endoscopic Myotomy (POEM) and Prolonged Dilatation (PRD) as Additional Endoscopic Treatment Options for Achalasia and Other Esophageal Motility Disorders
Overview
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.
Interventions
- Procedure Endoscopic intervention A
POEM: Per oral endoscopic myotomy - Procedure Endoscopic intervention B
PRD: Prolonged dilatation by temporary implantation of large diameter stent . Stents are additionally attached to the esophageal wall by different technical options. - Procedure Endoscopic intervention C
Endoscopic balloon dilatation - Procedure Laparoscopic Surgery
Laparoscopic Heller myotomy
Primary outcome measures
- Achalasia specific symptoms according to the Eckardt score (0-12) [Time frame: 6 mo post-op]
Secondary outcome measures (4)
- Barium column height (cm) in esophagogram [Time frame: 6 mo post-op]
- Resting pressure (mmHg) at the lower esophageal sphincter [Time frame: 6 mo post-op]
- Stent migration [Time frame: p.o. day 1]
- Percent of time (min)/24h that the pH is less than 4.0 in pH-metry [Time frame: 6 mo post-op]
Eligibility criteria
Inclusion criteria
- Confirmed diagnosis of achalsia, hypertensive lower esophageal sphincter, nutcracker esophagus, or diffuse esophageal spasm
Exclusion criteria
- Contraindication for EGD
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Austria · 1 center
- Department of Surgery, Medical University of Vienna — Vienna
Identifiers
NCT: NCT02518542 · POETA