| CTRI Number |
CTRI/2025/12/098591 [Registered on: 08/12/2025] Trial Registered Prospectively |
| Last Modified On: |
14/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Bacterial infections in bile duct cancers |
|
Scientific Title of Study
|
The study of association of Helicobacter infections in biliary tract cancers |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Niyatank Tyagi |
| Designation |
Senior Resident |
| Affiliation |
Institute of liver and biliary sciences |
| Address |
Cubicle 9, 3rd floor phase 1
Department of HPB surgery and Liver transplant
ILBS, D1 Vasant kunj, New Delhi.
South West
DELHI
110070
India |
| Phone |
8299584636 |
| Fax |
|
| Email |
tyagi.niyatank29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nihar Ranjan Mohapatra |
| Designation |
Associate Professor |
| Affiliation |
Institute of liver and biliary sciences |
| Address |
Room no 3311, 3rd floor phase 2
Department of HPB surgery and Liver transplant
ILBS, D1 Vasant kunj, New Delhi
South West
DELHI
110070
India |
| Phone |
9910479799 |
| Fax |
|
| Email |
nihar0310@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nihar Ranjan Mohapatra |
| Designation |
Associate Professor |
| Affiliation |
Institute of liver and biliary sciences |
| Address |
Room no 3311, 3 rd floor phase 2
Department of HPB surgery and Liver transplant
ILBS, D1 Vasant kunj, New Delhi
South West
DELHI
110070
India |
| Phone |
9910479799 |
| Fax |
|
| Email |
nihar0310@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of liver and biliary sciences, D 1 Vasant kunj,New Delhi 110070 |
|
|
Primary Sponsor
|
| Name |
Institute of liver and biliary sciences |
| Address |
ILBS, D 1 Vasant kunj,New Delhi 110070 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Niyatank Tyagi |
Institute of liver and biliary sciences |
Department of HPB surgery and Liver transplant
Institute of liver and biliary sciences, D 1 Vasant kunj, New Delhi
South West
DELHI |
8299584636
tyagi.niyatank29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K839||Disease of biliary tract, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
This is an observational study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
Patients who have taken H.pylori eradication previously |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the prevalence of Helicobacter sp. in Biliary tract cancers and benign biliary diseases |
Base line |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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
Gallbladder polyp
Porcelain gallbladder
Primary sclerosing cholangitis
Metaplasia or dysplasia
Stone size more than 2 cm
Abnormal pancreaticobiliary junction
Chronic liver disease patients with Hepatitis B & C
|
Baseline |
|
|
Target Sample Size
|
Total Sample Size="228"
Sample Size from India="228"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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.
|