Loading clinical trials...
Loading clinical trials...
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
ILBS
New Delhi, National Capital Territory of Delhi, India
Start Date
March 31, 2025
Primary Completion Date
March 31, 2026
Completion Date
May 31, 2026
Last Updated
December 12, 2025
250
ESTIMATED participants
No intervention
OTHER
Lead Sponsor
Institute of Liver and Biliary Sciences, India
NCT05489211
NCT04900818
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions