| CTRI Number |
CTRI/2025/09/094510 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Response of transarterial chemo embolisation with Bleomycin ,as compared to Symptomatic medical management, in terms of reduction in the size of lesion in patients with giant/symptomatic hepatic hemangioma |
|
Scientific Title of Study
|
Effectiveness of Bleomycin-Lipiodol Transarterial Chemoembolization Therapy in Hepatic Hemangioma: A Pilot Non-Randomised Controlled Trial
|
| 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 Kaushal Jain |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Radio-diagnosis and interventional radiology, All India institute of medical sciences, New Delhi
New Delhi
DELHI
110049
India |
| Phone |
8890654122 |
| Fax |
|
| Email |
jkaushal2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajendra Kumar Behera |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
NCA block, Department of Radio-diagnosis and interventional radiology, All India institute of medical sciences , New Delhi
New Delhi
DELHI
110049
India |
| Phone |
9821624353 |
| Fax |
|
| Email |
newhoperajendra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kaushal Jain |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Radio-diagnosis and interventional radiology, All India institute of medical sciences, New Delhi
New Delhi
DELHI
110049
India |
| Phone |
8890654122 |
| Fax |
|
| Email |
jkaushal2001@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [] |
|
|
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 Kaushal Jain |
All India institute of medical sciences |
Room no. 80, Department of Radiodiagnosis and Interventional Radiology
New Delhi
DELHI |
8890654122
jkaushl2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D134||Benign neoplasm of liver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bleomycin lipiodol trans arterial chemo embolisation |
Trans arterial chemo embolisation using maximum 30 mg Bleomycin in 5 mL Saline with maximum 20 mL lipiodol, later embolisation with gel foam slurry. Symptomatic medical management will be provided if and when required. |
| Comparator Agent |
Symptomatic medical management |
Only Symptomatic medical management including analgesics, antiemetics will be provided |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 18 years
Patients with imaging diagnosis of typical hemangioma of size more than 5 cm or who are symptomatic
Patients willing to give consent for the study
|
|
| ExclusionCriteria |
| Details |
Age less than 18 years
Pregnant patients
Patients with asymptomatic Hepatic Hemangioma measuring less than 5 cm
Patients diagnosed with suspected Hemangioma with imaging revealing alternate diagnosis.
Patients who have received any form of treatment in past for Hepatic Hemangioma
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Size reduction |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Symptomatic resolution |
6 months |
| Procedural complications |
Post procedural period |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
20/09/2025 |
| 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="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
|
This study is a non randomised, parallel arms, single centre, active-controlled trial for assessment of the effectiveness of Bleomycin Lipiodol Transarterial Chemoembolization (TACE) in patients with giant or symptomatic hepatic hemangioma that will be conducted in India at a single tertiary care centre (All India Institute of Medical Sciences, New Delhi), in comparison to patients receiving only symptomatic medical management . The primary outcome will be measurement of size reduction at 6 months. The secondary outcomes will be to assess symptomatic resolution at 6 months and to assess the post procedural complications associated with TACE. |