Achalasia
Conditions
Keywords
Achalasia, Heller myotomy, Dysphagia, Peroral Endoscopic Myotomy
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.
Interventions
PROCEDUREEndoscopic 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.
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada, Germany, Netherlands, Switzerland
Outcome results
None listed