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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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).

 
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