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Clinical Trials in India / NCT06909188
Recruiting Observational

The Study of Association of Helicobacter Infections in Biliary Tract Cancers

NCT06909188 · tracked via the Priya Life Science India tracker
Sponsor
Institute of Liver and Biliary Sciences, India
Phase
Observational
Started
2025-03-31
Last updated
2025-12-12

Condition(s) studied

Biliary Tract Cancer

Investigational drug(s) / intervention(s)

No intervention

No intervention: No Intervention

Study summary

Biliary tract carcinoma (BTC) includes gallbladder carcinoma, hilar cholangiocarcinoma, and distal cholangiocarcinoma, intrahepatic cholangiocarcinoma. Chronic infections of the biliary tract are major drivers of cancer. Helicobacter species is one of the most established pro-oncogenic pathogens for gastric malignancy.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Biliary tract carcinoma patients who underwent resection * 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: * Patients who have taken H.pylori eradication previously in last three months.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
ILBS New Delhi National Capital Territory of Delhi Recruiting

More Institute of Liver and Biliary Sciences, India trials in India

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06909188 on ClinicalTrials.gov ↗ ← All trials in India