| CTRI Number |
CTRI/2024/09/073588 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
14/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Glue vs Glue plus plug] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
N-butyl cyanoacrylate glue vs vascular plug and N-butyl cyanoacrylate glue combination as embolic agent for portal vein embolization before major hepatic resection:A randomized controlled trial. |
|
Scientific Title of Study
|
N-butyl cyanoacrylate vs vascular plug and N-butyl cyanoacrylate combination as embolic agent for pre-operative portal vein embolization: A randomized 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 Suman Mandal |
| Designation |
Junior Resident(academic) |
| Affiliation |
AIIMS , Bhubaneswar |
| Address |
Department of Radiodiagnosis, AIIMS Bhubaneswar, Sijua, Patrapada, Bhubaneswar, Khordah, Odisha
Khordha ORISSA 751019 India |
| Phone |
7602161324 |
| Fax |
|
| Email |
suman.narendrapur@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Tara Prasad Tripathy |
| Designation |
Assistant Professor and Guide |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Department of Radiodiagnosis, AIIMS Bhubaneswar, Sijua, Patrapada, Bhubaneswar, Khordah, Odisha
Khordha ORISSA 751019 India |
| Phone |
8575827990 |
| Fax |
|
| Email |
taraprasad.mkcg@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Tara Prasad Tripathy |
| Designation |
Assistant Professor and Guide |
| Affiliation |
AIIMS, Bhubaneswar |
| Address |
Department of Radiodiagnosis, AIIMS Bhubaneswar, Sijua, Patrapada, Bhubaneswar, Khordah, Odisha
Khordha ORISSA 751019 India |
| Phone |
8575827990 |
| Fax |
|
| Email |
taraprasad.mkcg@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Bhubaneswar, Sijua, Patrapada, Bhubaneswar-751019, Odisha, India |
|
|
Primary Sponsor
|
| Name |
Dr Suman Mandal |
| Address |
Department of Radiodiagnosis, AIIMS Bhubaneswar, Sijua, Patrapada, Bhubaneswar-751019, Khordah, Odisha, India
|
| Type of Sponsor |
Other [self] |
|
|
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 Suman Mandal |
AIIMS Bhubaneswar |
Cath Lab, Department of Radiodiagnosis AIIMS,Sijua, Patrapada, Bhubaneswar, Khordah, Odisha Khordha ORISSA |
7602161324
suman.narendrapur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, (2) ICD-10 Condition: K769||Liver disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Portal vein embolization using NBCA glue only. |
Portal vein embolization using NBCA glue as embolic agent which is a permanent embolic material. Portal branches will be assessed through a ultrasound guided transhepatic percutaneous approach . After a initial portography , embolization of non- FLR portal branches will be achieved with NBCA glue. |
| Intervention |
Portal vein embolization using NBCA glue plus vascular plug |
Portal vein embolization using NBCA glue and Amplatzer nitinol vascular plug. Both of these are permanent embolic material. Portal branches will be assessed through a ultrasound guided transhepatic percutaneous approach . After a initial portography , embolization of non- FLR portal branches will be achieved with NBCA glue followed by placement of a nitinol vascular plug proximally. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients with inadequate FLR planned for portal vein embolization before major liver resections. |
|
| ExclusionCriteria |
| Details |
1. Patients denying consent
2. Locally unresectable disease
3. Distant metastasis
4. Child Pugh B and C cirrhotic patients
5. Clinically significant portal hypertension
6. Extensive intrahepatic portosystemic shunts
7. Tumor thrombus extending into portal vein
8. Women during pregnancy or breastfeeding.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of absolute FLR hypertrophy at 14 days and 28 days after PVE. FLR absolute hypertrophy was calculated as (FLR volume after PVE-FLR volume before PVE) x 100/ (FLR volume before PVE) |
At 14 and 28 days post portal vein embolization |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of additional volumetric liver growth variables (degree of hypertrophy and kinetic growth rate) between the PVE groups included |
At 14 and 28 days post portal vein embolization |
| Total contrast material volume used |
At the time of portal vein embolization procedure |
| Pain intensity according to visual analog scale (range, 0–10) |
At the time of portal vein embolization procedure |
| total fluoroscopy and procedure time |
At the time of portal vein embolization procedure |
| Minor and major complications, and hospital stay |
During hospital stay post procedure |
|
|
Target Sample Size
|
Total Sample Size="42" Sample Size from India="42"
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)
|
01/10/2024 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
For many individuals with primary
or metastatic liver tumors, the only treatment that offers a chance of cure is the
surgical removal of part of the liver. Thanks to recent improvements in
surgical methods and care after surgery, this major procedure can now be done
with a relatively low risk of death. Nonetheless, the operation carries a
significant risk of liver failure afterward, due to the substantial amount of
liver tissue that is removed. To minimize this risk, evaluating the volume of
the liver that will remain after surgery (known as the future liver remnant or
FRL) is a crucial step in preparing patients for the procedure.
The
goal of PVE is to promote contralateral hypertrophy by occluding portal vein
branches on one side of the liver. However, the best embolic material for this
procedure has yet to be determined. However, it is indicated that N-butyl
cyanoacrylate (NBCA) may cause superior liver enlargement. This liquid embolic
material has also been linked to quicker hypertrophy and less need for contrast
material and radiation than other regularly utilized materials. Vascular plug
and NBCA combination have been shown to be safe in avoiding non-target
embolization and achieving adequate FLR hypertrophy. However, there has not
been any randomized control trial to compare the efficacy in increasing the FLR
volume by PVE with NBCA as compared to NBCA in combination with vascular plug.
Our aims to establish the comparative efficacy and safety of the two embolic agents
of PVE and contribute towards the understanding further. The study will be conducted as a prospective randomized controlled trail in the department of Radiodiagnosis in AIIMS Bhubaneswar. The hypothesis will be whether the combination of NBCA and a vascular plug more effective to using NBCA alone for promoting hypertrophy of future liver remnant after portal vein embolization prior to major liver resection. In the intervention group, patients will undergo portal vein embolization using NBCA glue plus vascular plug combination. In the control group , patients will undergo portal vein embolization using NBCA glue alone. The sample size would be 42(21 in each arm). The primary objective will be Assessment
of absolute FLR hypertrophy at 14 days and 28 days after PVE. FLR absolute
hypertrophy was calculated as (FLR volume after PVE-FLR volume before PVE) x
100/ (FLR volume before PVE). |