Overview

This trial is active, not recruiting.

Condition achalasia
Treatment endoscopic peroral myotomy
Sponsor Universitätsklinikum Hamburg-Eppendorf
Start date April 2011
End date July 2012
Trial size 70 participants
Trial identifier NCT01405417, UKE HH Endoscopy PV3725mc

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
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.

Primary Outcomes

Measure
Eckhard symptom score at 3 month after peroral endoscopic myotomy
time frame: Score is evaluated at 3 month after peroral endoscopic myotomy

Secondary Outcomes

Measure
Lower esophageal sphincter pressure
time frame: Lower esophageal sphincter pressure is determined by manometry at 3 month after peroral endoscopic myotomy
Reflux Symptoms
time frame: Reflux Symptoms are evaluated at 3 month after peroral endoscopic myotomy

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Endoscopic Peroral Myotomy for Treatment of Achalasia: Multicenter Study
Principal investigator Thomas Roesch, Prof. Dr.
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Universitätsklinikum Hamburg-Eppendorf.