Achalasia Clinical Trial
Official title:
Endoscopic Peroral Myotomy for Treatment of Achalasia: Pilot Study
This study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a single center setting in Europe.
This pilot study intends to investigate the feasibility, safety and efficacy of peroral
endoscopic myotomy for the treatment of achalasia in a single center setting in Europe.
16 patients are enrolled to evaluate feasibility, safety and efficacy of peroral endoscopic
myotomy. Main outcome measurement is the eckhardt symptom score 3 month after therapy.
Primary outcome:
-eckhardt 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, esophagal-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. An electric
generator 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.
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