Endoscopic Peroral Myotomy for Treatment of Achalasia

Not Applicable

Terminated

• Conditions: Achalasia
• Interventions: Procedure: Endoscopic Peroral Myotomy

• Registration Number: NCT01405417
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

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 Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-05-26
• Study First Submitted QC: 2011-07-28
• Study First Posted: 2011-07-29
• Primary Completion: 2012-07
• Study Completion: 2017-09
• Status Verified: 2019-04
• Last Update Submitted: 2019-06-05
• Last Update Posted: 2019-06-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peroral endoscopic myotomy	Endoscopic Peroral 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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (5)

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

Klinik für Gastroenterologie, USZ; 🇨🇭 Zürich, Switzerland