Histologic evaluation of patients with dysplasia after treatment of helicobacter pylori result of screening program, the study population is all patients over 50 years. Inclusion criteria: all patients over 50 years in the endoscopic evaluation of gastric precancerous lesions in Lashtenesha research project; patients with displasia in pathology. Exclusion criteria: Consent to participate in the research. After determining of pathology results, we call to patients with dysplasia then they refer to Gastrointestinal and Liver Diseases Research Center and get treated four drug therapy against helicobacter pylori included: tab clarithromycin 500 miligram one number every 12 hours, cap amoxiciline 500 miligram two numbers every 12 hours, tab bismuth sub citrate 120 miligram two numbers every 12 hours, tab pantoprazol 40 miligram one number daily during two weeks. Patients undergo endoscopy three months after completion of treatment. Two years later, the patient are again done endoscopy and biopsy by specialty gastroenterologist. During endoscopy, five samples are taken from body, angularis, antrum and fundus of stomach and one sample for Rapid Urease Test for helicobacter pylori and evaluation of dysplastic lesions
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201406191155N20
Registration date:2014-07-25, 1393/05/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-07-25, 1393/05/03
Registrant information
Name
Farahnaz Joukar
Name of organization / entity
Guilan University of Medical Sciences, Gastrointestinal and liver disease Research Center
Country
Iran (Islamic Republic of)
Phone
+98 13 1553 5116
Email address
info@gldrc.org
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2011-03-01, 1389/12/10
Expected recruitment end date
2014-03-26, 1393/01/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Histologic evaluation of patients with dysplasia after treatment of Helicobacter pylori result of screening program
Public title
Histologic evaluation of patients with dysplasia after treatment of helicobacter pylori
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients over 50 years in the endoscopic evaluation of gastric precancerous lesions in Lashtenesha research project; patients with displasia in pathology.
Exclusion criteria: No consent to participate in the research.
Age
From 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
35
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Guilan University of Medical Sciences. Ethics Committee Gastrointestinal and Liver Diseases Research
Street address
Gastrointestinal and Liver Diseases Research Center, Razi Hospital,Sardar Jangal Ave, Rasht,Guilan ْ
City
Rasht
Postal code
955655-41488
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
ش-175
Health conditions studied
1
Description of health condition studied
Dysplasia
ICD-10 code
D00.2
ICD-10 code description
Carcinoma in situ of stomach
Primary outcomes
1
Description
Treatment of helicobacter pylori
Timepoint
Two weeks
Method of measurement
Rapid urease test
Secondary outcomes
1
Description
Evaluation of dysplasia
Timepoint
Three months after helicobacter treatment
Method of measurement
Endoscopy
Intervention groups
1
Description
Intervention group take tab clarithromycin 500 miligram one number every 12 hours ,cap amoxiciline 500 miligram two numbers every 12 hours , tab bismuth sub citrate 120 miligram two numbers every 12 hours , tab pantoprazol 40 miligram one number daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastrointestinal clinic of Razi hospital
Full name of responsible person
Farahnaz Joukar
Street address
Gastrointestinal and Liver Diseases Research Center, Razi Hospita, Sardare Jangal Avenue
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vince chancellor for reaserch Guilan University of Medical Sciences
Full name of responsible person
Dr Rasool Tabari KHomeirani
Street address
Sadati st, Namjoo st, Rasht,Guilan
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vince chancellor for reaserch Guilan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Gastrointestinal and Liver Disease Research Center(GLDRC)
Full name of responsible person
Farahnaz Joukar
Position
assistant of gastrointestinal and liver disease research center (GLDRC)
Other areas of specialty/work
Street address
Gastrointestinal and Liver Disease Research Center (GLDRC), Razi hospital, Sardar Jangal Ave.
City
Rasht
Postal code
Phone
+98 13 1553 5116
Fax
Email
F_Jokar@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
gastrointestinal and liver disease research center (GLDRC)
Full name of responsible person
Dr.Fariboraz Mansou-Ghanaei
Position
Full Professor of Internal Medicine & Gastroenterology
Other areas of specialty/work
Street address
Gastrointestinal and liver disease research center (GLDRC), Razi hospital, Sardar Jangal Ave.
City
Rasht
Postal code
Phone
+98 13 1553 5116
Fax
Email
ghanaei@gums.ac.ir
Web page address
www.gldrc.org
Person responsible for updating data
Contact
Name of organization / entity
Gastrointestinal and liver disease research center
Full name of responsible person
Dr. Maryam Bakhshandeh
Position
General Physician
Other areas of specialty/work
Street address
Gastrointestinal and liver disease research cente, Razi hospital, Sardar Jangal Ave.
City
Rasht
Postal code
Phone
+98 13 1553 5116
Fax
Email
bmaryamb@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)