Ignite Creation Date:
2024-05-06 @ 2:38 PM
Last Modification Date:
2024-10-26 @ 1:35 PM
Study NCT ID:
NCT04386772
Status:
UNKNOWN
Last Update Posted:
2020-06-17
First Post:
2020-05-01
Brief Title:
Portal Vein Embolization Using Coils Plus TAGM vs Multiple Coils for Patients With Perihilar Cholangiocarcinoma or Hepatocellular Carcinoma
Sponsor:
Eastern Hepatobiliary Surgery Hospital
Organization:
Eastern Hepatobiliary Surgery Hospital
Study Overview
Official Title:
Preoperative Portal Vein Embolization Using Coils Plus TAGM vs Multiple Coils for Patients With Perihilar Cholangiocarcinoma or Hepatocellular Carcinoma a Randomized Controlled Study
Status:
UNKNOWN
Status Verified Date:
2020-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to investigate the differences of safety and liver hypertrophy between portal vein embolization PVE using coils plus tris-acryl gelatin microspheres TAGM and multiple coils in patients with perihilar cholangiocarcinoma pCCA or with hepatocellular carcinoma HCC
Detailed Description:
Perihilar cholangiocarcinoma pCCA and hepatocellular carcinoma HCC both are common primary hepatobiliary tumors which often require extensive hepatic resection and challenge perioperative management as surgery remains the only chance of long-term survival for such patients PVE induces effective hypertrophy on one side of the liver parenchyma ahead of a planned liver resection of the other side which becomes atrophic
Technically the percutaneous transhepatic approach becomes the standard of care for PVE PVEs themselves with different embolization materials could vary in the degree of liver hypertrophy though some techniques such as TAE HVE and stem cell have been already used in combination with PVE and could promote the hypertrophy Several aspects on the use of PVE are insufficiently studied and most recommendations are based on low-grade evidence Large clinical studies that compare the effect of different embolic materials on the hypertrophy response are lacking PVE using multiple coils to completely occlude all the target segmental and sectional branches is a conventional and fundamental approach in our center which ensured a reliable hypertrophy response with a low PVE-related morbidity and post-hepatectomy liver failure rate in the past decades PVE using with tris-acryl gelatin microspheres TAGM distally and coils proximally which needs more interventional experience has become one of standard approaches in our center However the study of high-grade evidence regarding the hypertrophy effect of PVE with TAGM and coils is still lacking
In this randomized study the investigators aim to compare PVE using TAGM plus coils to PVE using coils alone in term of PVE-related complications hypertrophy degree hepatectomy completion rate post-hepatectomy liver failure rate features of immunohistochemical examination on parenchyma for patients stratified by either pCCA or HCC
Technically the percutaneous transhepatic approach becomes the standard of care for PVE PVEs themselves with different embolization materials could vary in the degree of liver hypertrophy though some techniques such as TAE HVE and stem cell have been already used in combination with PVE and could promote the hypertrophy Several aspects on the use of PVE are insufficiently studied and most recommendations are based on low-grade evidence Large clinical studies that compare the effect of different embolic materials on the hypertrophy response are lacking PVE using multiple coils to completely occlude all the target segmental and sectional branches is a conventional and fundamental approach in our center which ensured a reliable hypertrophy response with a low PVE-related morbidity and post-hepatectomy liver failure rate in the past decades PVE using with tris-acryl gelatin microspheres TAGM distally and coils proximally which needs more interventional experience has become one of standard approaches in our center However the study of high-grade evidence regarding the hypertrophy effect of PVE with TAGM and coils is still lacking
In this randomized study the investigators aim to compare PVE using TAGM plus coils to PVE using coils alone in term of PVE-related complications hypertrophy degree hepatectomy completion rate post-hepatectomy liver failure rate features of immunohistochemical examination on parenchyma for patients stratified by either pCCA or HCC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None