NCT06909188Recruiting
The Study of Association of Helicobacter Infections in Biliary Tract Cancers
Source: ClinicalTrials.gov · Last updated 12 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 250 (estimated)
- First submitted
- 27 Mar 2025
- Start date
- 31 Mar 2025
- Primary completion date
- 31 Mar 2026
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06909188
What you commit to
- Study type: Observational
- Planned participants: 250
- From 31 Mar 2025 to the primary completion date, 31 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have taken H.pylori eradication previously in last three months.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ILBS Coordinator of this site? Confirm its status | New Delhi | India | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.