Helicobacter infections and biliary tract cancers
Official title: The Study of Association of Helicobacter Infections in Biliary Tract Cancers
Run by Institute of Liver and Biliary Sciences, India · NCT06909188 · Data updated 2026-11-12
This study will test whether Helicobacter bacteria (H. pylori, H. bilis, H. hepaticus) are more common in people with biliary tract cancers than in people with benign gallbladder conditions or healthy liver donors.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Institute of Liver and Biliary Sciences, India Academic / other |
| Locations | 1 site (New Delhi, National Capital Territory of Delhi) |
| Status | Recruiting |
| Started | March 31, 2025 |
| Main results expected | March 31, 2026 |
| Study ends | May 31, 2026 |
| Registry record updated | December 12, 2025 |
| Trial ID | NCT06909188 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults undergoing biliary or gallbladder tissue removal (for cancer, benign disease, or high-risk conditions) or voluntary healthy liver donors who have not had H. pylori eradication in the past three months.
✕Probably not a fit
People not undergoing surgical tissue or bile collection or those treated for H. pylori within the last three months are unlikely to be eligible or directly benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center observational study will compare the presence of Helicobacter species in biliary/gallbladder tissue and bile across four groups: patients with biliary tract carcinoma undergoing resection, patients undergoing cholecystectomy for benign disease, patients with high-risk biliary conditions undergoing cholecystectomy, and voluntary healthy liver donors without gallbladder pathology. Collected tissue and bile samples will undergo histopathology and microbiological testing to detect Helicobacter spp. and measure prevalence in each group. Patients who received H. pylori eradication therapy within the prior three months are excluded. The study is conducted at the Institute of Liver and Biliary Sciences in New Delhi.
Why it matters
Potential benefit: If a strong link is found, identifying Helicobacter in the biliary tract could lead to new prevention, screening, or diagnostic strategies for biliary tract cancers.
How similar studies have gone: Prior studies have reported mixed results, with some detecting H. pylori, H. bilis, or H. hepaticus in bile or gallbladder tissues of cancer patients but findings have been inconsistent and remain under investigation.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Ilbs
New Delhi, National Capital Territory of Delhi, India Recruiting
Study contacts
- Study coordinator: Niyatank Tyagi, MS
- Email: tyagi.niyatank29@gmail.com
- Phone: 01146300000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.