Endoscopic Peroral Myotomy for Treatment of Achalasia
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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.
|
Outcome Measures
Primary Outcome Measures
- Eckhard symptom score at 3 month after peroral endoscopic myotomy [Score is evaluated at 3 month after peroral endoscopic myotomy]
Validated symptom score based on dysphagia, pain, regurgitation and weight loss
Secondary Outcome Measures
- Lower esophageal sphincter pressure [Lower esophageal sphincter pressure is determined by manometry at 3 month after peroral endoscopic myotomy]
Manometry study
- Reflux Symptoms [Reflux Symptoms are evaluated at 3 month after peroral endoscopic myotomy]
Symptoms as reported by the patient
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient with symptomatic achalasia and pre-op barium swallow, manometry and esophagogastroduodenoscopy which are consistent with the diagnosis
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persons of age > 18 years with medical indication for surgical myotomy or Endoscopic balloon dilatation
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Signed written informed consent.
Exclusion Criteria:
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Patients with previous surgery of the stomach or esophagus
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Patients with known coagulopathy
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Previous achalasia-treatment with surgery
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Patients with liver cirrhosis and/or esophageal varices
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Active esophagitis
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Eosinophilic esophagitis
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Barrett's esophagus
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Pregnancy
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Stricture of the esophagus
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Malignant or premalignant esophageal lesion
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Candida esophagitis
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Hiatal hernia > 2cm
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinic for Visceral- and Thoracic Surgery, McGill University Health Centre | Montreal | Quebec | Canada | H3G 1A4 |
| 2 | Clinic for Visceral-, Vasular- and Thoracic Surgery, Markus-Krankenhaus | Frankfurt am Main | Germany | 60431 | |
| 3 | Universitätsklinikum Hamburg-Eppendorf, Klinik für Interdisziplinäre Endoskopie | Hamburg | Germany | 20246 | |
| 4 | Department of Gastroenterology and Hepatology, Academic Medical Center | Amsterdam | Netherlands | 1105 AZ | |
| 5 | Klinik für Gastroenterologie, USZ | Zürich | Switzerland |
Sponsors and Collaborators
- Universitätsklinikum Hamburg-Eppendorf
Investigators
- Principal Investigator: Thomas Roesch, Prof. Dr., Universitätsklinikum Hamburg-Eppendorf
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Inoue H, Minami H, Kobayashi Y, Sato Y, Kaga M, Suzuki M, Satodate H, Odaka N, Itoh H, Kudo S. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy. 2010 Apr;42(4):265-71. doi: 10.1055/s-0029-1244080. Epub 2010 Mar 30.
- von Renteln D, Inoue H, Minami H, Werner YB, Pace A, Kersten JF, Much CC, Schachschal G, Mann O, Keller J, Fuchs KH, Rösch T. Peroral endoscopic myotomy for the treatment of achalasia: a prospective single center study. Am J Gastroenterol. 2012 Mar;107(3):411-7. doi: 10.1038/ajg.2011.388. Epub 2011 Nov 8.
- UKE HH Endoscopy PV3725mc