Portal Vein Embolization Using Coils Plus TAGM vs Multiple Coils for Patients With Perihilar Cholangiocarcinoma or Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04386772
• Other study ID #: EHBHKY2018-02-024
• Status: Recruiting
• Phase: N/A
• Start date: May 27, 2020
• Est. completion date: December 2022

Study information

• Verified date: June 2020
• Source: Eastern Hepatobiliary Surgery Hospital
• Contact: Feng SHEN, MD, PhD
• Phone: 0086-21-81875005
• Email: shenfengehbh[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Male or female patients > 18 years and = 70 years of age.

• Diagnosis of pCCA or HCC (through imaging, serology, and/or histological biopsy)

• Performance status: Karnofsky score = 70

• Candidates for right portal vein embolization for potential major hepatectomy with curative intent. Volumetric indication for PVE is less than 40% of standardized FLR.

• Selective biliary drainage on FLR side for patients with pCCA should be performed when total bilirubin level is above 85.5µmol/L or bile duct dilation of FLR presents. Transcatheter arterial chemoembolization should be performed between 1 and 4 weeks before PVE for patients with HCC.

• Criteria of liver function: Child-Pugh A-B7 level, serum total bilirubin < 85.5µmol/L after biliary drainage in pCCA, alanine aminotransferase and aspartate aminotransferase = 3 times the upper limit of normal value.

• Patients who can understand this trial and have signed the informed consent.

Exclusion Criteria:

• Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction, which may affect the treatment.

• Patients with a history of any other malignant tumor, or allergic to iodine or gelatin.

• Subjects participating in other clinical trials.

• Platelet count < 80×109/L and/or moderate or severe esophageal varices.

• ICGR15 = 15% for HCC patients

• Obstructive jaundice lasts for >2 months before PVE for pCCA patients.

• Tumor becomes unresectable by local progression and/or distant metastasis presents before PVE.

• Right portal vein is occluded by tumor invasion or embolus before PVE.

• Free portal vein pressure >20 mmHg or porto-hepatic vein fistula at the beginning of PVE procedure.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Cholangiocarcinoma
• Cholangiocarcinoma, Perihilar
• Hepatocellular Carcinoma
• Hypertrophy
• Klatskin Tumor
• Liver; Hypertrophy, Acute
• Portal Vein Occlusion

Intervention

Procedure:
• PVE with coils plus TAGM
PVE with TAGM distally and coils proximally and subsequent scheduled major hepatectomy. Sequential transcatheter arterial chemoembolization and PVE for patients with HCC. Selective biliary drainage on future liver remnant (FLR) side for patients with pCCA when obstructive jaundice is present.
• PVE with multiple coils
Procedure: PVE with multiple coils PVE with multiple coils proximally and distally and subsequent scheduled major hepatectomy. Sequential transcatheter arterial chemoembolization and PVE for patients with HCC. Selective biliary drainage on FLR side for patients with pCCA when obstructive jaundice is present.

Locations

Country	Name	City	State
China	Easter hepatobiliary surgery hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Hepatobiliary Surgery Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PVE related morbidity	The rate of major and minor PVE-related complications	During and 2 weeks after PVE procedure
Primary	Hypertrophy degree of standardized FLR	The difference of standardized FLR ratios before and 2 weeks after PVE	2 weeks after PVE procedure
Secondary	Hepatectomy completion rate	The rate of completed major hepatectomy in each Arm group	The end of hepatectomy procedure
Secondary	Liver failure rate after major hepatectomy	The rate of liver failure measured by 50-50, TB peak 7mg, and ISGLS criteria	3 months after hepatectomy
Secondary	Immunohistochemical stainings of liver parenchyma	Immunohistochemical stainings of hypertrophic and atrophic parenchyma including anti-albumin, anti-PCNA, TUNEL staining, etc.	During (sampling) and immediately after hepatectomy (IHC examination)