Portal Vein OcclusionNCT04386772
Portal Vein Embolization Using Coils Plus TAGM vs Multiple Coils for Patients With Perihilar Cholangiocarcinoma or Hepatocellular Carcinoma
A study testing PVE with coils plus TAGM and PVE with multiple coils in people with Portal Vein Occlusion and Cholangiocarcinoma, Perihilar, run by Eastern Hepatobiliary Surgery Hospital at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Portal Vein Occlusion, Cholangiocarcinoma, Perihilar, Hepatocellular Carcinoma
- What is being tested?
- PVE with coils plus TAGM and PVE with multiple coils
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 27 May 2020to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Easter hepatobiliary surgery hospital
Shanghai, Shanghai Municipality, 200438
Bin YI, MD, 021-81887565, billyyi11@163.com
About this study
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
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).
Read the 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.
- Conditions
- Portal Vein Occlusion, Cholangiocarcinoma, Perihilar, Hepatocellular Carcinoma, Liver; Hypertrophy, Acute
- Being tested
- PVE with coils plus TAGM, PVE with multiple coils
- Keywords
- Portal vein embolization, Trisacryl gelatin microspheres, Coils, Major hepatectomy, Liver hypertrophy
- Medical subject headings
- Klatskin Tumor, Carcinoma, Hepatocellular, Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVE with coils plus TAGMProcedure or surgery
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 coilsProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| PVE with coils plus TAGM | Experimental | PVE with coils proximally plus TAGM distally and subsequent major hepatectomy Receives: Procedure: PVE with coils plus TAGM |
| PVE with multiple coils | Active comparator | PVE with multiple coils and subsequent major hepatectomy Receives: Procedure: PVE with multiple coils |
What is being measured
The primary outcome is the main question the study is designed to answer.
PVE related morbidity
The rate of major and minor PVE-related complications
Measured: During and 2 weeks after PVE procedure
Hypertrophy degree of standardized FLR
The difference of standardized FLR ratios before and 2 weeks after PVE
Measured: 2 weeks after PVE procedure
Secondary outcomes (3)
Hepatectomy completion rate
The rate of completed major hepatectomy in each Arm group
Measured: The end of hepatectomy procedure
Liver failure rate after major hepatectomy
The rate of liver failure measured by 50-50, TB peak 7mg, and ISGLS criteria
Measured: 3 months after hepatectomy
Immunohistochemical stainings of liver parenchyma
Immunohistochemical stainings of hypertrophic and atrophic parenchyma including anti-albumin, anti-PCNA, TUNEL staining, etc.
Measured: During (sampling) and immediately after hepatectomy (IHC examination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start27 May 2020
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal Vein OcclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Hepatobiliary Surgery Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Feng, Eastern Hepatobiliary Surgery Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386772
- Sponsor's protocol ID
- EHBHKY2018-02-024
- Status last verified
- Jun 2020
- First submitted
- 1 May 2020
- Last updated
- 17 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04386772
- Acronym / sponsor ID
- EHBHKY2018-02-024
- Conditions
- Portal Vein Occlusion, Cholangiocarcinoma, Perihilar, Hepatocellular Carcinoma, Liver; Hypertrophy, Acute
- Keywords
- Portal vein embolization, Trisacryl gelatin microspheres, Coils, Major hepatectomy, Liver hypertrophy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Eastern Hepatobiliary Surgery HospitalUniversity, hospital or other
- Study start
- 27 May 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVE with coils plus TAGM | Experimental | Procedure: PVE with coils plus TAGMPVE with coils proximally plus TAGM distally and subsequent major hepatectomy |
| PVE with multiple coils | Active comparator | Procedure: PVE with multiple coilsPVE with multiple coils and subsequent major hepatectomy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PVE with coils plus TAGMPVE 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 or surgery | PVE with coils plus TAGM |
| PVE with multiple coilsProcedure: 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. | Procedure or surgery | PVE with multiple coils |
Primary outcome
PVE related morbidity
Time frame: During and 2 weeks after PVE procedure
The rate of major and minor PVE-related complications
Hypertrophy degree of standardized FLR
Time frame: 2 weeks after PVE procedure
The difference of standardized FLR ratios before and 2 weeks after PVE
3 secondary outcomes
Hepatectomy completion rate
Time frame: The end of hepatectomy procedure
Liver failure rate after major hepatectomy
Time frame: 3 months after hepatectomy
Immunohistochemical stainings of liver parenchyma
Time frame: During (sampling) and immediately after hepatectomy (IHC examination)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PVE with coils plus TAGM and PVE with multiple coils in people with Portal Vein Occlusion and Cholangiocarcinoma, Perihilar, run by Eastern Hepatobiliary Surgery Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng SHEN, MD, PhD (0086-21-81875005, shenfengehbh@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PVE related morbidity (time frame: During and 2 weeks after PVE procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2020.