Endoscopic Peroral Myotomy for Treatment of Achalasia
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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 multi center setting.
| Condition | Intervention |
|---|---|
|
Achalasia |
Procedure: Endoscopic Peroral 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: Multicenter Study |
- Eckhard symptom score at 3 month after peroral endoscopic myotomy [ Time Frame: Score is evaluated at 3 month after peroral endoscopic myotomy ] [ Designated as safety issue: No ]Validated symptom score based on dysphagia, pain, regurgitation and weight loss
- Lower esophageal sphincter pressure [ Time Frame: Lower esophageal sphincter pressure is determined by manometry at 3 month after peroral endoscopic myotomy ] [ Designated as safety issue: No ]Manometry study
- Reflux Symptoms [ Time Frame: Reflux Symptoms are evaluated at 3 month after peroral endoscopic myotomy ] [ Designated as safety issue: No ]Symptoms as reported by the patient
| Enrollment: | 70 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | April 2017 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Peroral endoscopic myotomy
Patients with achalasia who are designed to either have balloon dilatation or botulinum toxine injection, or to have surgical intervention (Heller myotomy) for therapy. 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. |
Procedure: Endoscopic Peroral Myotomy
Endoscopic peroral 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 study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a multi center s
70 patients will be enrolled to evaluate feasibility, safety and efficacy of peroral endoscopic myotomy. Main outcome measurement is the Eckardt symptom score at 3 month after peroral endoscopic myotomy.
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 esophagogastroduodenoscopy 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| Canada, Quebec | |
| Clinic for Visceral- and Thoracic Surgery, McGill University Health Centre | |
| Montreal, Quebec, Canada, H3G 1A4 | |
| Germany | |
| Clinic for Visceral-, Vasular- and Thoracic Surgery, Markus-Krankenhaus | |
| Frankfurt am Main, Germany, 60431 | |
| Universitätsklinikum Hamburg-Eppendorf, Klinik für Interdisziplinäre Endoskopie | |
| Hamburg, Germany, 20246 | |
| Netherlands | |
| Department of Gastroenterology and Hepatology, Academic Medical Center | |
| Amsterdam, Netherlands, 1105 AZ | |
| Switzerland | |
| Klinik für Gastroenterologie, USZ | |
| Zürich, Switzerland | |
| Principal Investigator: | Thomas Roesch, Prof. Dr. | Universitätsklinikum Hamburg-Eppendorf |
More Information
Additional Information:
Publications:
| Responsible Party: | Prof. Dr. Thomas Rösch, Prof. Dr. Thomas Roesch, Universitätsklinikum Hamburg-Eppendorf, Endoscopy department, Universitätsklinikum Hamburg-Eppendorf |
| ClinicalTrials.gov Identifier: | NCT01405417 History of Changes |
| Other Study ID Numbers: | UKE HH Endoscopy PV3725mc |
| Study First Received: | May 26, 2011 |
| Last Updated: | September 6, 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 June 18, 2013