Clinical trial · Interventional
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
NCT04386772CI-TRIAL-00045584unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangiocarcinoma, Perihilar | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.85 |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver; Hypertrophy, Acute | — | UNRESOLVED | — |
| Portal Vein Occlusion | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PVE with coils plus TAGM | Procedure | — | UNRESOLVED |
| PVE with multiple coils | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PVE with coils plus TAGM
- description
- PVE with coils proximally plus TAGM distally and subsequent major hepatectomy
- interventionNames
- Procedure: PVE with coils plus TAGM
- type
- ACTIVE_COMPARATOR
- label
- PVE with multiple coils
- description
- PVE with multiple coils and subsequent major hepatectomy
- interventionNames
- Procedure: PVE with multiple coils
Primary outcomes (2)
- measure
- PVE related morbidity
- timeFrame
- During and 2 weeks after PVE procedure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.