The Study of Association of Helicobacter Infections in Biliary Tract Cancers

Institute of Liver and Biliary Sciences, India

Status

Enrolling

Conditions

Biliary Tract Cancer

Treatments

Other: No intervention

Study type

Observational

Funder types

Other

Identifiers

NCT06909188

ILBS- BILIARY TRACT CANCERS01

Details and patient eligibility

About

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.

Full 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.

Enrollment

250 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

250 participants in 4 patient groups

Benign Gallbladder diseases

Description:

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

Treatment:

Other: No intervention

Voluntary healthy liver donors

Description:

Gall bladder samples from Voluntary Healthy liver donors undergoing cholecystectomy.

Treatment:

Other: No intervention

Patients with high risk for biliary tract malignancy

Description:

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

Treatment:

Other: No intervention

Biliary tract carcinoma

Description:

Patients undergoing surgery for biliary tract cancers.

Treatment:

Other: No intervention