The Study of Association of Helicobacter Infections in Biliary Tract Cancers

NCT06909188 | Recruiting

• 1 other identifier: ILBS- BILIARY TRACT CANCERS01
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Biliary Tract Cancer

Outcome Measures

Primary Outcomes (1)

• To compare the prevalence of Helicobacter sp. in Biliary tract cancers and benign biliary diseases.

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Secondary Outcomes (2)

• To assess correlation of Helicobacter infection with disease stage in Biliary tract cancers.

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• To assess the correlation of Helicobacter infection with high risk conditions -

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Study Arms (4)

Benign Gallbladder diseases

Patients with Benign biliary disease(Gall stone disease) undergoing laparoscopic cholecystectomy will be included

Other: No intervention

Voluntary healthy liver donors

Gall bladder samples from Voluntary Healthy liver donors undergoing cholecystectomy.

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

Other: No intervention

Biliary tract carcinoma

Patients undergoing surgery for biliary tract cancers.

Other: No intervention

Interventions

No intervention OTHER

No Intervention

Benign Gallbladder diseases; Biliary tract carcinoma; Patients with high risk for biliary tract malignancy; Voluntary healthy liver donors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Patients who have taken H.pylori eradication previously in last three months.

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

ILBS

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Histopathology Samples will be assessed for immuno histochemistry and Polymerase chain reaction for Helicobacter species identification

MeSH Terms

Conditions

Biliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Central Study Contacts

Niyatank Tyagi, MS

CONTACT

01146300000; tyagi.niyatank29@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 3, 2025
• Study Start: March 31, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

IN (1)