| 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
|
|
|
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
|
|
|
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
|
|
|
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. |