N/A
N=16
Endoscopic Peroral Myotomy for Treatment of Achalasia
Achalasia
Bottom Line
View on ClinicalTrials.gov: NCT01405469 ↗Enrolled (actual)
16
Serious AEs
12.5%
Results posted
Dec 2014
Primary outcome: Primary: Treatment Success Defined as Symptom Relief 3 Months After Treatment Based on an Eckhardt Score ≤ 3 — 1.4; 8.8 Eckardt Score — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Peroral Endoscopic Myotomy (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Success Defined as Symptom Relief 3 Months After Treatment Based on an Eckhardt Score ≤ 3 |
1.4; 8.8 | <0.001 sig |
| SECONDARY mmHg of the Lower Esophageal Sphincter 3 Months After POEM Procedure |
11.8 | — |
| SECONDARY Number of Participants With Reflux Symptoms |
1 | — |
| SECONDARY Number of Participants With Procedure-related Adverse Events |
2 | — |
| SECONDARY Medication 3 Months After POEM |
1 | — |
| SECONDARY Duration Time Procedure |
114 | — |
| SECONDARY Days Duration Hospitalization |
4.5625 | — |
| SECONDARY cm Myotomy Length |
12 | — |
| SECONDARY Percentage of Participants Who Achieved Treatment Success 3 Months After Treatment |
94 | — |
Summary
This study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a single center setting in Europe.
Eligibility Criteria
Inclusion criteria
- Patient with symptomatic achalasia and pre-op barium swallow, manometry and esophagal-gastro-duodenoscopy which are consistent with the diagnosis
- persons of age > 18 years with medical indication for surgical myotomy or Endoscopic balloon dilatation
- Signed written informed consent.
Exclusion criteria
- Patients with previous surgery of the stomach or esophagus
- Patients with known coagulopathy
- Previous achalasia-treatment with surgery
- Patients with liver cirrhosis and/or esophageal varices
- Active esophagitis
- Eosinophilic esophagitis
- Barrett's esophagus
- Pregnancy
- Stricture of the esophagus
- Malignant or premalignant esophageal lesion
- Candida esophagitis
- Hiatal hernia > 2cm
Data sourced from ClinicalTrials.gov (NCT01405469). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.