| CTRI Number |
CTRI/2025/10/095726 [Registered on: 08/10/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Link Between H pylori Infection and Liver and Gallbladder Cancers |
|
Scientific Title of Study
|
Association between Helicobacter Pylori infection and Hepatobiliary Malignancy |
| 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 Harsh Mukesh Agrawal |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research. |
| Address |
Dept. of Surgery, 4th floor, SMSC Building, AVBRH Campus, Sawangi Meghe.
Wardha
MAHARASHTRA
442001
India |
| Phone |
7710828083 |
| Fax |
|
| Email |
agrawalhrsh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Darshana Tote |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research. |
| Address |
Dept. of Surgery, 4th floor, SMSC Building, AVBRH Campus, Sawangi Meghe.
Wardha
MAHARASHTRA
442001
India |
| Phone |
9923129974 |
| Fax |
|
| Email |
drtotedarshana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Darshana Tote |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research. |
| Address |
Dept. of Surgery, 4th floor, SMSC Building, AVBRH Campus, Sawangi Meghe.
MAHARASHTRA
442001
India |
| Phone |
9923129974 |
| Fax |
|
| Email |
drtotedarshana@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha, India 442002 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research. |
| Address |
Sawangi Meghe, Wardha, India 442002 |
| Type of Sponsor |
Private medical college |
|
|
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 Harsh Mukesh Agrawal |
Acharya Vinoba Bhave Rural Hospital |
Dept. of Surgery, 4th Floor, SMSC Building, AVBRH Campus, Sawangi Meghe
Wardha
MAHARASHTRA |
7710828083
agrawalhrsh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C228||Malignant neoplasm of liver, primary, unspecified as to type, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. All cases with hepatobiliary malignancy of age more than 18 years.
2. Individuals willing to give consent for study.
|
|
| ExclusionCriteria |
| Details |
1. Individuals having secondary deposits in liver.
2. Individuals who are not consenting for the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association between Helicobacter Pylori infection and Hepatobiliary Malignancy . |
Assessment will be done at 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="134"
Sample Size from India="134"
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)
|
03/12/2025 |
| 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="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Hepatobiliary malignancies are extremely dangerous cancers that comprise
a wide band of invasive carcinomas originating in the liver that is
hepatocellular carcinoma, the bile ducts intrahepatic cholangiocarcinoma and
extrahepatic cholangiocarcinoma , the gallbladder and the ampulla of Vater. This study aims to assess the association
between Helicobacter Pylori infection and Hepatobiliary Malignancy. This will be a observational study conducted at AVBRH Wardha. A total of 134 cases will be assessed. |