Clinical trial NCT06909188: The Study of Association of Helicobacter Infections in Biliary Tract Cancers
Official title: The Study of Association of Helicobacter Infections in Biliary Tract Cancers
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Biliary Tract Cancer
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2025-04-03
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Biliary tract carcinoma patients , Benign biliary disease undergoing laparoscopic cholecystectomy Healthy donors without any GB pathology and Retrospective samples of high risk/ precursor biliary condition.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To compare the prevalence of Helicobacter sp. in Biliary tract cancers and benign biliary diseases.
timeFrame: day 0
Secondary outcomes:
measure: To assess correlation of Helicobacter infection with disease stage in Biliary tract cancers.
timeFrame: day 0
measure: To assess the correlation of Helicobacter infection with high risk conditions -
timeFrame: day 0
Other outcomes:
Locations:
city: New Delhi
country: India
facility: ILBS
state: Delhi
Study officials:
References: