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CTRI Number  CTRI/2025/09/094450 [Registered on: 09/09/2025] Trial Registered Prospectively
Last Modified On: 08/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Transhepatic vs transsplenic PVE]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of safety and technique between portal vein embolization via liver and portal vein embolization via liver performed for liver growth before liver resection 
Scientific Title of Study   Comparison of safety and technical parameters between transhepatic (TH-PVE) and transsplenic (TS-PVE) portal vein embolization for future liver remnant (FLR) augmentation before hepatectomy: 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 Anu Thakur 
Designation  Junior Resident (Academic) 
Affiliation  AIIMS Bhubaneswar 
Address  Department of Radiodiagnosis, AIIMS Bhubaneswar, Sijua, Patrapada, Bhubaneswar, Khordha ORISSA 751019 India

Khordha
ORISSA
751019
India 
Phone  7018496900  
Fax    
Email  thakuranu814@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ranjan Kumar Patel 
Designation  Assistant Professor and Guide 
Affiliation  AIIMS Bhubaneswar 
Address  Department of Radiodiagnosis, AIIMS Bhubaneswar, Sijua, Patrapada, Bhubaneswar, Khordha ORISSA 751019 India

Khordha
ORISSA
751019
India 
Phone  8851228221  
Fax    
Email  ranjanair1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ranjan Kumar Patel 
Designation  Assistant Professor and Guide 
Affiliation  AIIMS Bhubaneswar 
Address  Department of Radiodiagnosis, AIIMS Bhubaneswar, Sijua, Patrapada, Bhubaneswar, Khordha ORISSA 751019 India

Khordha
ORISSA
751019
India 
Phone  8851228221  
Fax    
Email  ranjanair1@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Bhubaneswar 
 
Primary Sponsor  
Name  Dr Anu Thakur 
Address  Department of Radiodiagnosis, AIIMS Bhubaneswar, Sijua, Patrapada, Bhubaneswar, Khordah, Odisha  
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 Ranjan Kumar Patel  AIIMS Bhubaneswar  Ranjan Kumar Patel Near corridor No 4 Department of Radiodiagnosis, AIIMS Bhubaneswar PIN-751019
Khordha
ORISSA 
8851228221

radiol_ranjan@aiimsbhubaneswar.edu.in 
 
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: K77||Liver disorders in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Portal vein embolization via transhepatic route  Transhepatic PVE: Under a strict aseptic procedural field, intended PV access site is anesthesized using 10-12 ml of 2% lignocaine under real-time USG guidance till liver capsule. A small segmental PV branch ( preferably segment V or VI) is then punctured under the USG guidance using a 21 or 22G Chiba needle of a 5F Micropuncture set (Cook Medical). Once the intra portal needle positioning is confirmed by a gentle fluoroscopic contrast injection, a 0.018 inch floppy tipped guidewire will be advanced into the PV. Then, 0.018 system will be converted to a 0.045 system by inserting a dilator-stylet assembly. Over a 0.035 inch J tip hydrophilic guidewire (Terumo India), a 5F vascular sheath will be inserted into the portal vein. A portogram will be taken using a 5F KMP catheter, followed by embolization of the segmental PV branches using a glue-lipiodol mixture (1:5 to 1:6 ratio), leaving at least 1 cm of right main portal vein stump free of embolization to facilitate PV ligation during hepatic resection. If extended right hepatectomy is planned, additional embolization of segment IV portal vein branches will be performed. Depending on the anatomical variants, different shaped catheters might be required for segmental PV catheterization and embolization. In the end, the percutaneous transhepatic PV access tract will be embolised using the same glue (N-butyl cyanoacrylate)-lipiodol mixture till the level of liver capsule.  
Intervention  Portal vein embolization via transsplenic route   Transsplenic PVE (TS-PVE): All the transsplenic portal vein embolization will be performed with patient lying supine and operator standing on the left side of the patient. After infiltration of local anaesthesia till the splenic capsule, an intraparenchymal SV branch near the splenic hilum (SV branch should be in line with the main SV) will be punctured using 21 or 22G Chiba needle of the micropuncture set. Then, similar to transhepatic access, 0.018 system will be converted into a 0.035 system and a 5F vascular sheath will be inserted. A portogram will be taken after cannulating the main PV, followed by selective glue embolization (glue: lipiodol= 1:5 to 1:6 ratio) of the target PV branches. A final portogram will be taken to confirm the adequate embolization. In the end, the transsplenic tract will be embolised using a combination pushable coils/gelfoam slurry and 50% glue-lipiodol mixture.  
 
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 
To compare the procedure-related major and minor complications between TH-PVE and TS-PVE
To compare the procedural technique-related parameters between TH-PVE and TS-PVE

 
With in 30 days of portal vein embolization
At the time of portal vein embolization procedure 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the degree of hypertrophy of the future liver remnant (FLR)following PVE, measured as percentage increase in FLR volume using CT volumetric imaging  At 4-5 wks post portal vein embolization 
To compare the procedural challenges (if any) during hepatectomy between the TH-PVE and TS-PVE groups  At the time of hepatectomy 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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)   25/09/2025 
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  

Major hepatic resections are often required for the curative treatment of hepatic and biliary malignancies such as hepatocellular carcinoma, cholangiocarcinoma, Gallbladder carcinoma and colorectal or neuroendocrine hepatic metastases. In patients with insufficient future liver remnant (FLR), preoperative portal vein embolization (PVE) is a well-established technique to enhance FLR hypertrophy by redirecting portal flow, thereby reducing the risk of postoperative liver failure.

Glue (N-butyl cyanoacrylate) is the embolic material of choice owing to its instant PV obliteration and superior FLR hypertrophy. Traditionally, transhepatic route is preferred for PVE, either through an ipsilateral or contralateral approach. Despite technical ease, ipsilateral approach is increasingly preferred than contralateral approach for right hepatectomy to avoid the risk of FLR damage. However, ipsilateral transhepatic route possesses several disadvantages. Firstly, ipsilateral approach is associated with difficult cannulation of PV branches due to sharp angulation and may require different shaped catheters, including SIM1 catheter which in turn increases the procedure time and radiation exposure. Second, inadvertent proximal glue embolization may pose difficulty in hooking of different PV branches during the process of embolization. Further, at least 1 cm stump of right PV free of embolization is required for PV ligation during hepatectomy. However, glue is difficult to control and the operator may find difficulty in controlling glue flow while embolizing. Sometimes, non-target embolization into the FLR has also been noticed, especially in the process of final flush venography. There is a possibility of glue spillage into the perihepatic space during tract embolization. This spilled glue may cause perihepatic adhesion, creating technical difficulty during hepatic resection.  Lastly, transhepatic approach carries a risk of unintentional biliary puncture, increasing the risk of cholangitis, cholangitic abscess and biloma formation .

With the evolution of techniques, hardwires and availability of USG, trans splenic access is gaining popularity for various portal-hypertension related interventions. Recent studies have shown no significant increase in bleeding risk with trans splenic access as compared to transhepatic access.  In a subset of patients, trans  splenic access may be a viable alternative to transhepatic PVE, especially when extensive tumoral infiltration precludes a transhepatic PV access. Antegrade access to PV via trans splenic route could have advantages of straight forward catheterization of right portal vein branches and superior glue control with easy embolization of individual PV branches. It eliminates the risk of dislodgement of embolic agent during final venogram. Trans splenic access will also preclude the risk of perihepatic adhesion resulting from glue spillage.

 Despite the growing use of the trans splenic approach, there is limited evidence directly comparing it to the transhepatic route in PVE in terms of safety and difference in technical parameters as well as challenges faced during hepatic resection.

The study will be conducted as prospective randomized control trial in department of Radiodiagnosis in AIIMS Bhubaneswar. This study aims to evaluate and compare the safety and technical parameters between transhepatic and trans splenic PVE in a prospective manner, providing evidence to guide route selection and optimize outcomes in patients undergoing major liver resection.

 
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