This study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a multi center setting.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
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.
Clinic for Visceral- and Thoracic Surgery, McGill University Health Centre
Montreal, Quebec, Canada
Clinic for Visceral-, Vasular- and Thoracic Surgery, Markus-Krankenhaus
Frankfurt am Main, Germany
Universitätsklinikum Hamburg-Eppendorf, Klinik für Interdisziplinäre Endoskopie
Hamburg, Germany
Department of Gastroenterology and Hepatology, Academic Medical Center
Amsterdam, Netherlands
Eckhard symptom score at 3 month after peroral endoscopic myotomy
Validated symptom score based on dysphagia, pain, regurgitation and weight loss
Time frame: Score is evaluated at 3 month after peroral endoscopic myotomy
Lower esophageal sphincter pressure
Manometry study
Time frame: Lower esophageal sphincter pressure is determined by manometry at 3 month after peroral endoscopic myotomy
Reflux Symptoms
Symptoms as reported by the patient
Time frame: Reflux Symptoms are evaluated at 3 month after peroral endoscopic myotomy
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Klinik für Gastroenterologie, USZ
Zurich, Switzerland