The Study of Association of Helicobacter Infections in Biliary Tract Cancers

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitute of Liver and Biliary Sciences, India

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • No intervention

Treatment groups

250 Participants
are divided into 4 treatment groups