| CTRI Number |
CTRI/2021/05/033803 [Registered on: 25/05/2021] Trial Registered Prospectively |
| Last Modified On: |
31/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [Image-guided Ablative Therapy] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare two types of therapy in locally advanced gall bladder cancer: Chemotherapy combined with irreversible electroporation versus chemotherapy alone |
|
Scientific Title of Study
|
Comparison of chemotherapy combined with percutaneous electroporation and chemotherapy alone in the management of locally advanced carcinoma of the gall bladder |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CRG/2020/005400 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Naveen Kalra |
| Designation |
Professor |
| Affiliation |
PGIMER |
| Address |
Department of Radiodiagnosis,
PGIMER,
Sector 12,
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855426320 |
| Fax |
2744401 |
| Email |
navkal2004@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Naveen Kalra |
| Designation |
Professor |
| Affiliation |
PGIMER |
| Address |
Department of Radiodiagnosis,
PGIMER,
Sector 12,
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855426320 |
| Fax |
2744401 |
| Email |
navkal2004@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Naveen Kalra |
| Designation |
Professor |
| Affiliation |
PGIMER |
| Address |
Department of Radiodiagnosis,
PGIMER,
Sector 12,
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855426320 |
| Fax |
2744401 |
| Email |
navkal2004@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Science and Engineering Research Board, DST |
|
|
Primary Sponsor
|
| Name |
SERB |
| Address |
5&5A, Lower Ground Floor, Vasant Square Mall,
Plot No A, Community Centre
Sector-B, Pocket-5,
Vasant Kunj,
New Delhi-10070 |
| Type of Sponsor |
Government funding agency |
|
|
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 Naveen Kalra |
PGIMER |
Department of Radiodiagnosis
PGIMER, Sector 12,
Chandiagarh
Chandigarh
CHANDIGARH |
9855426320
2744401
navkal2004@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C23||Malignant neoplasm of gallbladder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chemotherapy alone |
Chemotherapy (Gemcitabine and cisplatin) will be given
Follow-up imaging will be done at 1 month, 3 months and every 3 months subsequently |
| Intervention |
Chemotherapy combined with percutaneous irreversible electroporation(IRE) |
IRE will be done at presentation followed by chemotherapy (Gemcitabine and cisplatin)
Follow-up imaging will be done at 1 month, 3 months and every 3 months subsequently |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with unresectable malignant GB masses
2. Life expectancy of at least 3 months.
3. Size of tumor < 6 cm in largest dimension.
4. Total bilirubin level < 2.5 mg/dl |
|
| ExclusionCriteria |
| Details |
1. Uncorrectable coagulopathy
2. Patients with poor general condition and estimated life expectancy less than 3
months
3. Patients unfit for general anaesthesia
4. Presence of cardiac disease/arrhythmia/heart block
5. Presence of malignant ascites
6. Presence of metastatic disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Survival |
One year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Safety of the procedure
Quality of life |
Safety of the procedure-baseline
Quality of life-baseline and at 4 weeks
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/06/2021 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Gall bladder carcinoma (GBC) is the most common malignancy
of the biliary tract worldwide. However, most of the patients often present
late. Therefore, surgical resection may not be possible due to adjacent organ
involvement or local invasion. Chemotherapy is the first line of treatment in
unresectable GB masses with dismissal prognosis. In electrochemotherapy (ECT),
the short-term electric pulses with high voltage delivered to the tumor, leads
to transient pore formation in the cell membrane which enables the entry of
chemotherapeutic agents into the cells. The hypothesis of this study is that
the chemotherapy with electroporation may improve the outcome of GBC. This is a
randomized control trial of 30 patients with locally advanced GBC who will be
designated randomly into two equal groups. Group I will receive only chemotherapy
while Group II will receive both chemotherapy and percutaneous electroporation.
The primary outcome will be overall survival and the secondary outcome will be
safety and quality of life after the procedure. |