The Study of Association of Helicobacter Infections in Biliary Tract Cancers

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
India
ILBS
RECRUITING
New Delhi
Contact Information
Primary
Niyatank Tyagi, MS
tyagi.niyatank29@gmail.com
01146300000
Time Frame
Start Date: 2025-03-31
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 250
Treatments
Benign Gallbladder diseases
Patients with Benign biliary disease(Gall stone disease) undergoing laparoscopic cholecystectomy will be included
Voluntary healthy liver donors
Gall bladder samples from Voluntary Healthy liver donors undergoing cholecystectomy.
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
Biliary tract carcinoma
Patients undergoing surgery for biliary tract cancers.
Sponsors
Leads: Institute of Liver and Biliary Sciences, India

This content was sourced from clinicaltrials.gov