The Study of Association of Helicobacter Infections in Biliary Tract Cancers
NCT ID: NCT06909188
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
250 participants
OBSERVATIONAL
2025-03-31
2026-05-31
Brief Summary
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In addition to H Pylori, H.bilis and H.hepaticus have a significantly higher incidence in bile from biliary tract and gallbladder cancer patients than in patients with gallstones/cholecystitis.
This, together with the high prevalence of gallstones, makes it important to evaluate the role of Helicobacter in biliary tract cancers. This study aims to compare the prevalence of Helicobacter sp.(pylori, bilis, hepaticus). This study will include biliary tract carcinoma patients, benign biliary disease patients, high risk conditions for malignancy and Voluntary healthy liver donors with no gallbladder pathology. HPE samples will be assessed and association of Helicobacter sp will be studied among all 4 arms.
All the included samples will be assessed for Helicobacter species using giemsa stain and DNA PCR. Results will be studied to compare the prevalence of Helicobacter sp. in Biliary tract malignancy and benign biliary diseases.
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Benign Gallbladder diseases
Patients with Benign biliary disease(Gall stone disease) undergoing laparoscopic cholecystectomy will be included
No intervention
No Intervention
Voluntary healthy liver donors
Gall bladder samples from Voluntary Healthy liver donors undergoing cholecystectomy.
No intervention
No Intervention
Patients with high risk for biliary tract malignancy
Choledochal cyst Porcelain Gallbladder Gallbladder polyp Primary sclerosing cholangitis Metaplasia / dysplasia Stone size \>2 cm Abnormal pancreaticobiliary duodenal junction(APBDJ) Cholecystectomy in patients with both Hepatitis B and C Cholecystectomy in age more than 60 years Hepaticolithiasis
No intervention
No Intervention
Biliary tract carcinoma
Patients undergoing surgery for biliary tract cancers.
No intervention
No Intervention
Interventions
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No intervention
No Intervention
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing cholecystectomy for benign biliary disease.
* Voluntary healthy liver donors with no gallbladder pathology
* Patients undergoing cholecystectomy for conditions with high risk of malignancy
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Institute of Liver and Biliary Sciences, India
OTHER
Responsible Party
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Locations
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ILBS
New Delhi, National Capital Territory of Delhi, India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ILBS- BILIARY TRACT CANCERS01
Identifier Type: -
Identifier Source: org_study_id
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