跳至主要内容
临床试验/CTRI/2025/12/098591
CTRI/2025/12/098591尚未招募不适用

The study of association of Helicobacter infections in biliary tract cancers

Institute of liver and biliary sciences1 个研究点 分布在 1 个国家目标入组 228 人开始时间: 2025年12月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
228
试验地点
1
主要终点
To compare the prevalence of Helicobacter sp. in Biliary tract cancers and benign biliary diseases

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Biliary tract carcinoma patients who underwent resection Patients undergoing cholecystectomy benign biliary disease Voluntary healthy liver donors with no gallbladder pathology Patients undergoing cholecystectomy for conditions with high risk of malignancy.

排除标准

  • Patients who have taken H.pylori eradication previously.

结局指标

主要结局

To compare the prevalence of Helicobacter sp. in Biliary tract cancers and benign biliary diseases

时间窗: Base line

次要结局

  • To assess correlation of Helicobacter infection with disease stage in Biliary tract cancers(Baseline)
  • To assess the correlation of Helicobacter infection with high risk conditions(Choledochal cyst)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Niyatank Tyagi

Institute of liver and biliary sciences

研究点 (1)

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