Endoscopic Peroral Myotomy for Treatment of Achalasia (POEM)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Achalasia |
Other: Peroral Endoscopic Myotomy |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Endoscopic Peroral Myotomy for Treatment of Achalasia: Pilot Study |
- Successful symptom relief based after Peroral Endoscopic Myotomy. [ Time Frame: Eckhard score at 3 month after therapy ] [ Designated as safety issue: No ]Achalasia symptom score based on regurgitation, dysphagia, weight loss and pain
- Resting pressure of the lower esophageal sphincter [ Time Frame: Manometry at 3 month after therapy ] [ Designated as safety issue: No ]Manometry study (Resting pressure of the lower esophageal sphincter)
- Reflux Symptoms [ Time Frame: Reflux symptoms at 3 month after therapy ] [ Designated as safety issue: No ]Reflux symptoms as reported by the patient
| Enrollment: | 16 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | November 2015 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Peroral Endoscopic Myotomy
Patients with achalasia who are designed to either get balloon dilatation or have botulinum toxine injection, or to have surgical intervention (Heller myotomy)for treatment
|
Other: Peroral Endoscopic Myotomy
A forward-viewing upper endoscope is used with a transparent distal cap attachment. Carbon dioxide gas is necessary for insufflation during the procedures. An endoscopic knife is used to access the submucosa, dissect the submucosal tunnel and also to divide circular muscle bundles over a length of approximately 10cm, extending 2-3cm onto the cardia. A electrogenerator is used with spray coagulation mode. A coagulating forceps is used for hemostasis as needed. Closure of the mucosal entry site is performed using standard endoscopic clips
|
Detailed Description:
This pilot 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.
16 patients are enrolled to evaluate feasibility, safety and efficacy of peroral endoscopic myotomy. Main outcome measurement is the Eckhard symptom score 3 month after therapy.
Primary outcome:
-Eckhard symptom score 3 month after therapy.
Secondary outcomes:
- Lower esophageal sphincter pressure at 3 month after therapy.
- Reflux symptoms at 3 month after therapy.
For this prospective study, inclusion criteria are achalasia, as diagnosed by established methods (contrast fluoroscopy, manometry, esophago-gastro-duodenoscopy) and age greater than 18 years. Previous therapy, such as esophageal surgery or previous myotomy are exclusion criterion.
A forward-viewing upper endoscope is used with a transparent distal cap attachment. Carbon dioxide gas is necessary for insufflation during the procedures. An endoscopic knife is used to access the submucosa, dissect the submucosal tunnel and also to divide circular muscle bundles over a length of approximately 10cm, extending 2-3cm onto the cardia. A electrogenerator is used with spray coagulation mode. A coagulating forceps is used for hemostasis as needed. Closure of the mucosal entry site is performed using standard endoscopic clips.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Patient with symptomatic achalasia and pre-op barium swallow, manometry and esophago-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
Contacts and Locations| Germany | |
| Universitätsklinikum Hamburg-Eppendorf, Klinik für Interdisziplinäre Endoskopie | |
| Hamburg, Germany, 20246 | |
| Principal Investigator: | Thomas Roesch, Prof. Dr. | Universitätsklinikum Hamburg-Eppendorf |
More Information
Additional Information:
Publications:
| Responsible Party: | Universitätsklinikum Hamburg-Eppendorf |
| ClinicalTrials.gov Identifier: | NCT01405469 History of Changes |
| Other Study ID Numbers: | UKE Hamburg Endoscopy PV3725 |
| Study First Received: | May 26, 2011 |
| Last Updated: | November 2, 2012 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
|
Achalasia Heller myotomy Dysphagia Peroral Endoscopic Myotomy |
Additional relevant MeSH terms:
|
Esophageal Achalasia Esophageal Motility Disorders Deglutition Disorders |
Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013