Evaluation of effectiveness of H.pylori eradication on regression of gastric precancerous lesions in the first degree relatives of patients with gastric cancer. A long term double blind randomized controlled clinical trial
Aim: The aim of this study is the elucidate the regression of precancerous lesions (atrophy of gastric mucosa or intestinal metaplasia) in stomach by eradication of H. pylori in comparison to Placebo in a double blind randomized clinical trial in subjects having the risk for gastric cancer.
Inclusion criteria: all first degree relatives of gastric cancer patients with an age between 40 and 65 years were invited to undergo upper GI endoscopy. From all subjects, biopsy specimens were taken from 5 areas of stomach (2 from antrum and 3 from corpus) for evaluation of gastritis according to update Sidney classification and one from antrum for rapid urease test. All subjects with H. pylori (HP)-positive diffuse gastritis were randomly divided into two groups; one was treated with Placebo and the other received an eradication regimen for 2 weeks (Bismuth Subcitrate, Furazolidone, Metronidazole and Omeprazole).
Sample size: By a change of 15% (20% progression under placebo and 10% regression of precancerous lesions after eradication) and by 90% power 315 subjects were needed for each group.
Exclusion criteria: all with significant lesions by endoscopy (ulcer, diffuse gastric erosions or erosive duodenits, gastric neoplasia or severe dysplasia verified by histology) or negative HP (Negative urease test and no HP in all specimens) were excluded.
Follow Up and outcome: All subjects were followed for endoscopy and biopsy taking as before after 2 and 4 years.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138802071852N1
Registration date:2009-08-11, 1388/05/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-08-11, 1388/05/20
Registrant information
Name
Sadegh Massarrat
Name of organization / entity
Digestive Disease Research Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8241 5155
Email address
massarrat@ams.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences, Shariati Hospital, Digestive Disease Research Center
Expected recruitment start date
2001-05-22, 1380/03/01
Expected recruitment end date
2006-05-22, 1385/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effectiveness of H.pylori eradication on regression of gastric precancerous lesions in the first degree relatives of patients with gastric cancer. A long term double blind randomized controlled clinical trial
Public title
Evaluation of effectiveness of H.pylori eradication on regression of gastric precancerous lesions in the first degree relatives of patients with gastric cancer. A long term double blind randomized controlled clinical trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: First degree relatives of gastric cancer patients, age between 40 and 65 years, presence of diffuse gastritis, positive urease test
Exclusion criteria: significant lesions in stomach (ulcer, diffuse gastric erosions or erosive duodenits, gastric neoplasia or severe dysplasia verified by histology), negative Helicobacter Pylori (Negative urease test and no H. Pylori in all specimens by histology)
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
600
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Interruption of study was planned, when the aim (progression of atrophy or intestinal metaplasia under placebo and regression under eradication by 15%) was achieved at 2 years. No continuation of study will be performed up to 4 years.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee: Digestive Disease Research Center
Street address
Shariati Hospital
City
Tehran
Postal code
14117-13135
Approval date
2000-02-20, 1378/12/01
Ethics committee reference number
3th session of Ethics committee
Health conditions studied
1
Description of health condition studied
Gastric precancerous lesions
ICD-10 code
K31.9
ICD-10 code description
Disease of stomach and duodenum, unspecified
Primary outcomes
1
Description
Course of progression or regression of gastric atrophy and intestinal metaplasia under eradication or placebo treatment
Timepoint
Blood taking, 6 months and 2 and 4 years after first endoscopy and control endoscopy 2 and 4 years after start of trial
Method of measurement
Upper GI endoscopy and taking biopsies from different gastric areas 2 and 4 years after start of study and blood taking before first endoscopy, 6 months and 2 and 4 years after eradication or placebo treatment for determination of H.Pylori antibody and other biomarkers.
Secondary outcomes
1
Description
H.pylori eradication and regression of precancerous lesions (atrophy and intestinal metaplasia) under treatment and progression of precancerous lesions in placebo group
Timepoint
2 and 4 years
Method of measurement
Endoscopy and evaluation of histology according to Sidney classification after 2 and 4 years after begin of study
Intervention groups
1
Description
Omeprazole (2×20 mg, daily in 2 doses), Bismuth subcitrate (4×120 mg, daily in 2 doses), Furazolidone (4×100 mg, daily in 2 doses), Metronidazole (4×250 mg, daily in 2 doses).
Category
Treatment - Drugs
2
Description
Placebo tablets for colloidal Bismuth subcitrate, QID for 2 weeks, Placebo tablet for Furazolidone, QID 1 week, Placebo tablet for Metronidazole, QID for 2 weeks, Placebo caps for Omeprazole, BID for 2 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Street address
City
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Digestive Disease Research Center, Tehran University of Medical Sciences
Full name of responsible person
Prof. Sadegh Massarrat
Street address
North Kargar Ave., Shariati Hospital,
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Digestive Disease Research Center, Tehran 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
Digestive Disease Research Center, TUMS
Full name of responsible person
Prof. Sadegh Massarrat
Position
Professor of University
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 21 8241 5104
Fax
Email
massarrat@ams.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Digestive Disease Research Center, TUMS
Full name of responsible person
Prof Sadegh Massarrat
Position
Speciality in Internal Medicine, Subspeciality in gastroenterology and hepatology
Other areas of specialty/work
Street address
Digestive Disease Research Center, Shariati Hospital
City
Tehran
Postal code
Phone
+98 21 8241 5104
Fax
Email
massarrat@ams.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Prof. Sadegh Massarrat
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 21 8241 5104
Fax
Email
massarrat@ams.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)