Esophageal Achalasia
Conditions
Brief summary
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
PROCEDUREEndoscopic intervention A
POEM: Per oral endoscopic myotomy
PROCEDUREEndoscopic intervention B
PRD: Prolonged dilatation by temporary implantation of large diameter stent . Stents are additionally attached to the esophageal wall by different technical options.
PROCEDUREEndoscopic intervention C
Endoscopic balloon dilatation
PROCEDURELaparoscopic Surgery
Laparoscopic Heller myotomy
Sponsors
Medical University of Vienna
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of achalsia, hypertensive lower esophageal sphincter, nutcracker esophagus, or diffuse esophageal spasm
Exclusion criteria
* Contraindication for EGD
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Achalasia specific symptoms according to the Eckardt score (0-12) | 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
| Measure | Time frame | Description |
|---|---|---|
| Barium column height (cm) in esophagogram | 6 mo post-op | — |
| Resting pressure (mmHg) at the lower esophageal sphincter | 6 mo post-op | — |
| Stent migration | 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. |
| Percent of time (min)/24h that the pH is less than 4.0 in pH-metry | 6 mo post-op | — |
Countries
Austria
Contacts
Primary ContactDepartment of Surgery, Medical University of Vienna
Outcome results
None listed