Biliary Tract CancerNCT06909188
The Study of Association of Helicobacter Infections in Biliary Tract Cancers
An observational study of Biliary Tract Cancer, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Cancer
- How many people
- 250 participants
- Where
- 1 siteIndia
- Study dates
- 31 Mar 2025to 31 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Biliary tract carcinoma patients , Benign biliary disease undergoing laparoscopic cholecystectomy Healthy donors without any GB pathology and Retrospective samples of high risk/ precursor biliary condition.
Who may be able to join
- 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
Who cannot join
- Patients who have taken H.pylori eradication previously in last three months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
ILBS
New Delhi, National Capital Territory of Delhi, 110070
Niyatank Tyagi, MS, 01146300000, tyagi.niyatank29@gmail.com
About this study
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.
Read more
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.
Read the detailed 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. However, its role in biliary tract cancers is under investigation. Recently H. pylori has been associated with gallbladder pathologies like cholelithiasis, cholecystitis, choledocholithiasis, gallbladder polyps. However, some studies have also reported that chronic inflammation due to H. pylori infection causes biliary tract cancer. On the other hand, some studies have reported no association between H. pylori infection and gallbladder diseases. 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. Patients who have received H pylori eradication therapy will be excluded. 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.
- Conditions
- Biliary Tract Cancer
- Being tested
- No intervention
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| Benign Gallbladder diseases | Patients with Benign biliary disease(Gall stone disease) undergoing laparoscopic cholecystectomy will be included Receives: Other: No intervention | |
| Voluntary healthy liver donors | Gall bladder samples from Voluntary Healthy liver donors undergoing cholecystectomy. Receives: Other: No intervention | |
| Patients with high risk for biliary tract malignancy | Choledochal cyst Porcelain Gallbladder Gallbladder polyp Primary sclerosing cholangitis Metaplasia / dysplasia Stone size >2 cm Abnormal pancreaticobiliary duodenal junction(APBDJ) Cholecystectomy in patients with both Hepatitis B and C Cholecystectomy in age more than 60 years Hepaticolithiasis Receives: Other: No intervention | |
| Biliary tract carcinoma | Patients undergoing surgery for biliary tract cancers. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the prevalence of Helicobacter sp. in Biliary tract cancers and benign biliary diseases.
Measured: day 0
Secondary outcomes (2)
To assess correlation of Helicobacter infection with disease stage in Biliary tract cancers.
Measured: day 0
To assess the correlation of Helicobacter infection with high risk conditions -
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start31 Mar 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909188
- Sponsor's protocol ID
- ILBS- BILIARY TRACT CANCERS01
- Status last verified
- Dec 2025
- First submitted
- 27 Mar 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Association of Helicobacter Infections in Biliary Tract Cancers
- ClinicalTrials.gov ID
- NCT06909188
- Acronym / sponsor ID
- ILBS- BILIARY TRACT CANCERS01
- Conditions
- Biliary Tract Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 3 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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. However, its role in biliary tract cancers is under investigation. Recently H. pylori has been associated with gallbladder pathologies like cholelithiasis, cholecystitis, choledocholithiasis, gallbladder polyps. However, some studies have also reported that chronic inflammation due to H. pylori infection causes biliary tract cancer. On the other hand, some studies have reported no association between H. pylori infection and gallbladder diseases. 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. Patients who have received H pylori eradication therapy will be excluded. 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Benign Gallbladder diseases | – | Other: No interventionPatients with Benign biliary disease(Gall stone disease) undergoing laparoscopic cholecystectomy will be included |
| Voluntary healthy liver donors | – | Other: No interventionGall bladder samples from Voluntary Healthy liver donors undergoing cholecystectomy. |
| Patients with high risk for biliary tract malignancy | – | Other: No interventionCholedochal cyst Porcelain Gallbladder Gallbladder polyp Primary sclerosing cholangitis Metaplasia / dysplasia Stone size >2 cm Abnormal pancreaticobiliary duodenal junction(APBDJ) Cholecystectomy in patients with both Hepatitis B and C Cholecystectomy in age more than 60 years Hepaticolithiasis |
| Biliary tract carcinoma | – | Other: No interventionPatients undergoing surgery for biliary tract cancers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Biliary tract carcinoma patients , Benign biliary disease undergoing laparoscopic cholecystectomy Healthy donors without any GB pathology and Retrospective samples of high risk/ precursor biliary condition.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who have taken H.pylori eradication previously in last three months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo Intervention | Other | Benign Gallbladder diseases, Biliary tract carcinoma, Patients with high risk for biliary tract malignancy, Voluntary healthy liver donors |
Primary outcome
To compare the prevalence of Helicobacter sp. in Biliary tract cancers and benign biliary diseases.
Time frame: day 0
2 secondary outcomes
To assess correlation of Helicobacter infection with disease stage in Biliary tract cancers.
Time frame: day 0
To assess the correlation of Helicobacter infection with high risk conditions -
Time frame: day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Tract Cancer, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Niyatank Tyagi, MS (01146300000, tyagi.niyatank29@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the prevalence of Helicobacter sp. in Biliary tract cancers and benign biliary diseases. (time frame: day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.