The Study of Association of Helicobacter Infections in Biliary Tract Cancers

Not yet recruiting

• Conditions: Biliary Tract Cancer

• Registration Number: NCT06909188
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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. 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-27
• Study First Submitted QC: 2025-03-27
• Last Update Submitted: 2025-03-27
• Study Start: 2025-03-30
• Study First Posted: 2025-04-03
• Last Update Posted: 2025-04-03
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the prevalence of Helicobacter sp. in Biliary tract cancers and benign biliary diseases.	day 0

Secondary Outcome Measures

Name	Time	Method
To assess correlation of Helicobacter infection with disease stage in Biliary tract cancers.	day 0
To assess the correlation of Helicobacter infection with high risk conditions -	day 0

Trial Locations

Locations (1)

ILBS; 🇮🇳 New Delhi, Delhi, India