Helicobacter infections and biliary tract cancers
The Study of Association of Helicobacter Infections in Biliary Tract Cancers
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 |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institute of Liver and Biliary Sciences, India Academic / other |
| Locations | 1 site (New Delhi, National Capital Territory of Delhi) |
| Trial ID | NCT06909188 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
New Delhi, National Capital Territory of Delhi
- Ilbs — New Delhi, National Capital Territory of Delhi, India (Recruiting)
Study contacts
- Study coordinator: Niyatank Tyagi, MS
- Email: tyagi.niyatank29@gmail.com
- Phone: 01146300000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.