Portal Vein Embolization Using Coils Plus TAGM vs Multiple Coils for Patients With Perihilar Cholangiocarcinoma or Hepatocellular Carcinoma
Preoperative Portal Vein Embolization Using Coils Plus TAGM vs Multiple Coils for Patients With Perihilar Cholangiocarcinoma or Hepatocellular Carcinoma: a Randomized Controlled Study
1 other identifier
interventional
56
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2020
CompletedFirst Posted
Study publicly available on registry
May 13, 2020
CompletedStudy Start
First participant enrolled
May 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedJune 17, 2020
June 1, 2020
2.5 years
May 1, 2020
June 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
PVE related morbidity
The rate of major and minor PVE-related complications
During and 2 weeks after PVE procedure
Hypertrophy degree of standardized FLR
The difference of standardized FLR ratios before and 2 weeks after PVE
2 weeks after PVE procedure
Secondary Outcomes (3)
Hepatectomy completion rate
The end of hepatectomy procedure
Liver failure rate after major hepatectomy
3 months after hepatectomy
Immunohistochemical stainings of liver parenchyma
During (sampling) and immediately after hepatectomy (IHC examination)
Study Arms (2)
PVE with coils plus TAGM
EXPERIMENTALPVE with coils proximally plus TAGM distally and subsequent major hepatectomy
PVE with multiple coils
ACTIVE COMPARATORPVE with multiple coils and subsequent major hepatectomy
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Easter hepatobiliary surgery hospital
Shanghai, Shanghai Municipality, 200438, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Chief Surgeon, Principal Investigator
Study Record Dates
First Submitted
May 1, 2020
First Posted
May 13, 2020
Study Start
May 27, 2020
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
June 17, 2020
Record last verified: 2020-06