Studies Helicobacter bacteria in people with biliary tract cancer
Compares Helicobacter bacteria in bile and tissue from cancer and benign biliary disease patients.
Plain-language title generated from the registry record
Registry title: The Study of Association of Helicobacter Infections in Biliary Tract Cancers
Key facts
- Where
- New Delhi, IndiaSee the site
Where in India
- ILBSNew Delhi, IndiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Institute of Liver and Biliary Sciences, India
- Trial code
- NCT06909188
- Record updated
- 12 December 2025
- Original description
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.Read full original descriptionShow less
The Study of Association of Helicobacter Infections in Biliary Tract Cancers
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.
Inclusion: 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: Patients who have taken H.pylori eradication previously in last three months.