idiopathic achalasia. Achalasia of cardia
Conditions
Interventions
We have used 10cc of Ethanole amine oleat 2.5% divided in four parts and injected into 4 quadrants of LES (about 2 cm above Z-line) ..
Treatment - Drugs
We have used 10cc of Ethanole amine oleat 2.5% divided in four parts and injected into 4 quadrants of LES (about 2 cm above Z-line) .
Sponsors
Research assistance of Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion: poor candidate of PDT(sigmoid esophagus,epipherenic diverticula ,patients with poor operative risk, patients with poor cooperative history for PDT or surgery),Idiopathic achalasia,resistance to PDT,cooperative patients. Exclusion :patients with poor cooperation,secondary achalasia,good response to PDT or other standard therapy,pregnancy or breast feeding, active illicit drug or alcohol abuse, prior history of allergic reactions to agents belonging to the EO family, pregnancy or breast feeding; a history of severe co-morbid disease. Informed consent was obtained from each patient included in the study.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical resonse (clinical symptoms). Timepoint: pretreatment and 1.5, 3, 6, 9 and 12 months after thelast injection. Method of measurement: Questionnaire.;Barium volume (cubic ml)in 5th minute. Timepoint: pretreatment/post treatment (1.5-6-12months after last injection). Method of measurement: timed barium esophagogarm.;Barium height(mm)in 5th minute. Timepoint: pretreatment/post treatment(1.5-6-12months after last injection). Method of measurement: timed barium esophagogarm. | — |
Secondary
| Measure | Time frame |
|---|---|
| Perforation or bleeding of injection site. Timepoint: during injection. Method of measurement: endoscopy.;Esophagitis. Timepoint: during injection. Method of measurement: endoscopy.;Chest pain. Timepoint: first 24 hours after each injection. Method of measurement: observation and history taking. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Javad Mikaeli –Dr. Ramin Niknam
Tehran University of Medical Sciences
Outcome results
None listed