Study of the effectiveness of Sclerotherapy for treatment of idiopathic achalasia cases which are resistance to or have poor candidate of pneumatic balloon dilation
In this study Achalasic patients who are resistant or poor candidate for PD(pneumatic dilation),are treated by EO injection. EO is injected into the LES portion of patients" esophagous, and patients have been followed 1.5-3-6-9-12 months after the last injection.
Our primary outcomes in this study will be clinical response
which is assessed by symptom scoring and also timed esophagogram change
after EO injection.
In addition,complications ,resistance and relapse of symptoms will be
followed.
10 ml of 2.5% EO was applied by diluting 5%
EO 1:1 (v/v) in normal saline. 10 mL of diluted EO are
injected in divided dose through a 5 mm sclerotherapy needle into each of four quadrants, approximately 3 cm above the LES.Injection will
be repeated every two weeks up to six weeks.patients with sever complications such as perforation will exclude.In relapsed cases EO injection will
be repeated with the previous protocol. patients have evaluated before and after the treatment(1.5-3-6-9-12 months after the last injection) by symptom scoring and timed barium esophago gram(height and volume of retain barium in 5th minute).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903234170N1
Registration date:2011-01-20, 1389/10/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-01-20, 1389/10/30
Registrant information
Name
Ramin Niknam
Name of organization / entity
DDRC
Country
Iran (Islamic Republic of)
Phone
+98 21 8241 5000
Email address
niknam@ddrc.ac.ir
Recruitment status
Recruitment complete
Funding source
TUMS (Tehran University of Medical Sciences), DDRC (digestive disease research center)
Expected recruitment start date
2007-06-24, 1386/04/03
Expected recruitment end date
2010-06-24, 1389/04/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effectiveness of Sclerotherapy for treatment of idiopathic achalasia cases which are resistance to or have poor candidate of pneumatic balloon dilation
Public title
efficacy of sclerotherapy for treatment of achalasia
Purpose
Treatment
Inclusion/Exclusion 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.