Protocol summary

Summary
Determining gastric mapping for dysplasia and intestinal metaplasia in obese who are at increased risk of gastric cancer due to their obesity can be of value for determining places with higher probability of such pathologies and doing biopsy from these locations during endoscopy. Such mapping can also be helpful in better follow up of these patients for early diagnosis of cancerous lesions. This quasi-experimental study, will be done on 174 obese cases candidate for bariatric surgery who have tendency for doing gastric endoscopy with biopsy and aged between 18 and 70 years old. A general practitioner will evaluate demographic variables and determine height and weight. All patients who sign an informed consent form will be endoscopically evaluated and gastric biopsy will be done. CBC, platelet, ESR, CRP, FBS, TG, Chol, HDL, and LDL will also be determined after taking blood sample. Endoscopy will be done before surgery under sedation with propofol and after confirming by a cardiologist. Our outcome variables are: H. pylori infection, mucosal atrophy, chronic gastritis, reactive atypia of glandular epithelium, intestinal metaplasia, dysplasia, CBC, platelet, ESR, CRP, FBS, TG, Chol, HDL, and LDL.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201305204811N3
Registration date: 2015-05-23, 1394/03/02
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-05-23, 1394/03/02
Registrant information
Name
Ali Kabir
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 1993
Email address
a.kabir@nhri.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Gastric mapping for intestinal metaplasia and dysplasia in morbid obese patients candidate for bariatric surgery
Public title
Determining intestinal metaplasia and dysplasia in obese patients candidate for surgery
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: Morbid obese patients (BMI > 35 kg/m2), aged between 18 and 70 years old who are not involved in any other interventional study, have tendency for doing upper endoscopy and gastric biopsy. Exclusion criteria: Cases with any severe diseases of kidney and heart and any other end stage diseases.
Age
From 18 years old to 70 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size: 174
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
Ethics committee of Iran University of Medical Sciences
Street address
5th Floor, Central Building of Iran University of Medical Sciences,Hemmat Expway, between Sheikh fazlollah and Chamran Expway
City
Tehran
Postal code
Approval date
2015-05-11, 1394/02/21
Ethics committee reference number
94-01-14-25669-111701

Health conditions studied

1

Description of health condition studied
Obesity and sleep apnea
ICD-10 code
E66.2
ICD-10 code description
Extreme obesity with alveolar hypoventilation

2

Description of health condition studied
Obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories

3

Description of health condition studied
all types of obesity
ICD-10 code
E66.9
ICD-10 code description
Simple obesity NOS

4

Description of health condition studied
Morbid obesity
ICD-10 code
E66.8
ICD-10 code description
Morbid obesity

Primary outcomes

1

Description
gastric dysplasia
Timepoint
At the beginning of study
Method of measurement
gastric biopsy

2

Description
mucosal atrophy
Timepoint
At the beginning of study
Method of measurement
gastric biopsy

3

Description
H. pylori infection
Timepoint
At the beginning of study
Method of measurement
gastric biopsy

4

Description
gastric metaplasia
Timepoint
At the beginning of study
Method of measurement
gastric biopsy

5

Description
chronic gastritis
Timepoint
At the beginning of study
Method of measurement
gastric biopsy

6

Description
reactive atypia of glandular epithelium
Timepoint
At the beginning of study
Method of measurement
gastric biopsy

Secondary outcomes

1

Description
FBS
Timepoint
at the beginning of study
Method of measurement
ELISA

2

Description
TG
Timepoint
at the beginning of study
Method of measurement
ELISA

3

Description
Total Cholestrol, LDL, HDL
Timepoint
at the beginning of study
Method of measurement
ELISA

4

Description
CRP, ESR
Timepoint
at the beginning of study
Method of measurement
ELISA

Intervention groups

1

Description
All patients who sign an informed consent form will be endoscopically evaluated and gastric biopsy will be done. CBC, platelet, ESR, CRP, FBS, TG, Chol, HDL, and LDL will also be determined after taking blood sample. Endoscopy will be done before surgery under sedation with propofol and after confirming by a cardiologist.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Minimally invasive surgery research center and Endoscopy ward of the Hazrat Rasoul-e- Akram Hospital
Full name of responsible person
Dr Abdolreza Pazouki
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Dr Seyed Ali Javad Mousavi
Street address
Room #503, %th floor, Central building of Iran University of Medical Sciences, between Chamran and Hemmat Expways, Hemmat Expway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran 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
Iran University of Medical Sciences
Full name of responsible person
Ali Kabir
Position
MD, PhD of Epidemiology
Other areas of specialty/work
Street address
Minimally invasive surgery research center and Endoscopy ward of the Hazrat Rasoul-e- Akram Hospital, Mansouri St., Sattarkhan Ave.
City
Tehran
Postal code
Phone
00
Fax
Email
aikabir@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali Kabir
Position
MD, PhD of Epidemiology
Other areas of specialty/work
Street address
Minimally invasive surgery research center and Endoscopy ward of the Hazrat Rasoul-e- Akram Hospital , Mansouri St., Sattarkhan Ave.
City
Tehran
Postal code
Phone
+98 21 6655 5448
Fax
Email
aikabir@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali Kabir
Position
MD, PhD of Epidemiology
Other areas of specialty/work
Street address
Minimally invasive surgery research center and Endoscopy ward of the Hazrat Rasoul-e- Akram Hospital , Mansouri St., Sattarkhan Ave.
City
Tehran
Postal code
Phone
00
Fax
Email
aikabir@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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