Clinical Trial: Endoscopic Peroral Myotomy for Treatment of Achalasia

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Endoscopic Peroral Myotomy for Treatment of Achalasia: Pilot Study

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 Summary:

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.


Sponsor: Universitätsklinikum Hamburg-Eppendorf

Current Primary Outcome: Eckhard symptom score at 3 month after peroral endoscopic myotomy [ Time Frame: Score is evaluated at 3 month after peroral endoscopic myotomy ]

Validated symptom score based on dysphagia, pain, regurgitation and weight loss


Original Primary Outcome: Successful symptom relief based after Peroral Endoscopic Myotomy. [ Time Frame: Eckhard score at 3 month after therapy ]

Achalasia symptom score based on regurgitation, dysphagia, weight loss and pain


Current Secondary Outcome:

  • Lower esophageal sphincter pressure [ Time Frame: Lower esophageal sphincter pressure is determined by manometry at 3 month after peroral endoscopic myotomy ]
    Manometry study
  • Reflux Symptoms [ Time Frame: Reflux Symptoms are evaluated at 3 month after peroral endoscopic myotomy ]
    Symptoms as reported by the patient


Original Secondary Outcome:

  • Resting pressure of the lower esophageal sphincter [ Time Frame: manometry at 3 month after therapy ]
    Manometry study (Resting pressure of the lower esophageal sphincter)
  • Reflux Symptoms [ Time Frame: Reflux symptoms at 3 month after therapy ]
    Reflux symptoms as reported by the patient


Information By: Universitätsklinikum Hamburg-Eppendorf

Dates:
Date Received: May 26, 2011
Date Started: November 2010
Date Completion: September 2017
Last Updated: May 3, 2017
Last Verified: May 2017