Hilar CholangiocarcinomaNCT03320980
RALPPS in Patients With Hilar and Intrahepatic Cholangiocarcinoma
An observational study of Hilar Cholangiocarcinoma and Intrahepatic Cholangiocarcinoma, run by Moscow Clinical Scientific Center.
Trial summary
Unsatisfactory immediate outcomes of Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) in surgery of cholangiocarcinoma suggested that patients with biliary cancer should not be treated by ALPPS. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hilar Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma
- What is being tested?
- RALPPS and portal vein embolization + major liver resection
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2014to 1 Oct 2017
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients refered to the Center from other hospitals and primary care clinics
Who may be able to join
- h-CCA, type II-IV, T1-3N0-1M0, volume of FLR<40%
- i-CCA, T1-3N0-1M0, volume of FLR<40%
- Physical status 1-4 according to American Society of Anesthesiologists Physical Status Classification System
- BMI up to 40 kg/m2
- If cirrhosis is present, class A according to Child-Turcotte-Pugh score
Who cannot join
- h-CCA, stage 4A, B
- i-CCA, stage 4B
- i-CCA, T4N0-1M0
- i-CCA, h-CCA with volume of FLR >45%
- acute cholangitis and/or infected fluid collections, liver abscesses, other unresolved surgical complications of biliary draining procedures.
- jaundice with total bilirubin >50 µmol/L
Show all 14Show fewer
- prior anamnestic allergic reaction or any other sign of intolerance to iodinated contrast media
- Age under 18 years
- Age above 80 years
- Persons who are incapable of giving consent
- Pregnant or breast-feeding women
- Physical status >4 according to American Society of Anesthesiologists Physical Status Classification System
- BMI > 40 kg/m2
- If cirrhosis is present, class B, C according to Child-Turcotte-Pugh score
About this study
Official title: Split-in-situ Resection With Radio-frequency Ablation Instead of Liver Partition on the First Stage (RALPPS) in Patients With Hilar and Intrahepatic Cholangiocarcinoma
Unsatisfactory immediate outcomes of Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) in surgery of cholangiocarcinoma suggested that patients with biliary cancer should not be treated by ALPPS. Short-term results of ALPPS variants with reduced surgical trauma on the first stage in patients with cholangiocarcinoma were not yet estimated. The objective of the study was estimation of the short-term results of split-in-situ resection with radio-frequency ablation (RFA) instead of liver partition on the first stage (RALPPS) in patients with hilar (h-CCA) and intrahepatic (i-CCA) cholangiocarcinoma compared with portal vein embolization (PVE).
Read the detailed description
ALPPS has been recently proposed as the most effective method to induce marked and rapid hypertrophy of FLR with 95-100% completion rate of the second stage. The most common indication for ALPPS is locally advanced multiple colorectal liver metastases. Unsatisfactory immediate outcomes of ALPPS in surgery of cholangiocarcinoma (CCA) including high mortality reached 48% in patients with h-CCA suggested that patients with biliary cancer should not be treated by ALPPS.
Recently reported modifications of in situ splitting (partial ALPPS, RALPPS (radio-frequency-assisted liver partition with portal vein ligation for staged hepatectomy) and ALTPS (associating liver tourniquet and right portal vein ligation for staged hepatectomy) etc) have been aimed to minimize the operating injury on the first stage, hereby reducing postoperative morbidity.
The other important idea was to preserve all initial benefits of ALPPS in terms of liver hypertrophy and completeness of the second stage. To date, there is no evidence of the benefits of any new ALPPS modification over others in reducing the morbidity of procedure, particularly in patients with CCA..
- Being tested
- RALPPS, portal vein embolization + major liver resection
- Keywords
- ALPPS, RALPPS, Portal Vein Embolization, Hilar Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma
- Medical subject headings
- Klatskin Tumor, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RALPPSProcedure or surgery
RALPPS: split-in-situ resection with radio-frequency ablation (RFA) instead of liver partition on the first stage and major liver resection on the second stage
portal vein embolization + major liver resectionProcedure or surgery
PVE on the first stage and major liver resection on the second stage
| Study group | Role | What they receive |
|---|---|---|
| RALPPS | Patients with initial volume of FLR < 40% which underwent RALPPS and major liver resection (as the second stage of RALPPS) for hilar and intrahepatic cholangiocarcinoma Receives: Procedure: RALPPS | |
| Portal vein embolization (PVE) | Patients with initial volume of FLR < 40% undergoing PVE and major liver resection for hilar and intrahepatic cholangiocarcinoma Receives: Procedure: portal vein embolization + major liver resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Future Liver Remnant (FLR) Hypertrophy
Degree of FLR enlargement (%) with respect to initial volume of FLR [(Post-PVE FLR - Pre-PVE FLR) / (Pre-PVE FLR)] x 100
Measured: 10 days
Secondary outcomes (4)
Major morbidity after the first stage
Grade > II according to Clavien-Dindo classification
Measured: 10 days
Blood loss
Blood loss during second stage (major liver resection)
Measured: intraoperative parameter
Major morbidity after the second stage
Grade > II according to Clavien-Dindo classification
Measured: 90 days
Liver failure
Liver failure after the second stage according to criteria of International Study Group of Liver Surgery
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start15 Sep 2014
- Primary completion20 Sep 2017
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hilar CholangiocarcinomaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moscow Clinical Scientific Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mikhail Efanov, Principal investigator, Moscow Clinical Scientific Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320980
- Sponsor's protocol ID
- MCNC 09/2017
- Status last verified
- Oct 2017
- First submitted
- 10 Oct 2017
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Split-in-situ Resection With Radio-frequency Ablation Instead of Liver Partition on the First Stage (RALPPS) in Patients With Hilar and Intrahepatic Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT03320980
- Acronym / sponsor ID
- MCNC 09/2017
- Keywords
- ALPPS, RALPPS, Portal Vein Embolization, Hilar Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Moscow Clinical Scientific CenterUniversity, hospital or other
- Study start
- 15 Sep 2014 (actual)
- Primary completion
- 20 Sep 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 25 Oct 2017 (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.
Unsatisfactory immediate outcomes of Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) in surgery of cholangiocarcinoma suggested that patients with biliary cancer should not be treated by ALPPS. Short-term results of ALPPS variants with reduced surgical trauma on the first stage in patients with cholangiocarcinoma were not yet estimated. The objective of the study was estimation of the short-term results of split-in-situ resection with radio-frequency ablation (RFA) instead of liver partition on the first stage (RALPPS) in patients with hilar (h-CCA) and intrahepatic (i-CCA) cholangiocarcinoma compared with portal vein embolization (PVE).
Detailed description
ALPPS has been recently proposed as the most effective method to induce marked and rapid hypertrophy of FLR with 95-100% completion rate of the second stage. The most common indication for ALPPS is locally advanced multiple colorectal liver metastases. Unsatisfactory immediate outcomes of ALPPS in surgery of cholangiocarcinoma (CCA) including high mortality reached 48% in patients with h-CCA suggested that patients with biliary cancer should not be treated by ALPPS.
Recently reported modifications of in situ splitting (partial ALPPS, RALPPS (radio-frequency-assisted liver partition with portal vein ligation for staged hepatectomy) and ALTPS (associating liver tourniquet and right portal vein ligation for staged hepatectomy) etc) have been aimed to minimize the operating injury on the first stage, hereby reducing postoperative morbidity.
The other important idea was to preserve all initial benefits of ALPPS in terms of liver hypertrophy and completeness of the second stage. To date, there is no evidence of the benefits of any new ALPPS modification over others in reducing the morbidity of procedure, particularly in patients with CCA..
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RALPPS | – | Procedure: RALPPSPatients with initial volume of FLR < 40% which underwent RALPPS and major liver resection (as the second stage of RALPPS) for hilar and intrahepatic cholangiocarcinoma |
| Portal vein embolization (PVE) | – | Procedure: portal vein embolization + major liver resectionPatients with initial volume of FLR < 40% undergoing PVE and major liver resection for hilar and intrahepatic cholangiocarcinoma |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients refered to the Center from other hospitals and primary care clinics
Key inclusion criteria (5 listed)
- h-CCA, type II-IV, T1-3N0-1M0, volume of FLR<40%
- i-CCA, T1-3N0-1M0, volume of FLR<40%
- Physical status 1-4 according to American Society of Anesthesiologists Physical Status Classification System
- BMI up to 40 kg/m2
- If cirrhosis is present, class A according to Child-Turcotte-Pugh score
Key exclusion criteria (14 listed)
- h-CCA, stage 4A, B
- i-CCA, stage 4B
- i-CCA, T4N0-1M0
- i-CCA, h-CCA with volume of FLR >45%
- acute cholangitis and/or infected fluid collections, liver abscesses, other unresolved surgical complications of biliary draining procedures.
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 |
|---|---|---|
| RALPPSRALPPS: split-in-situ resection with radio-frequency ablation (RFA) instead of liver partition on the first stage and major liver resection on the second stage | Procedure or surgery | RALPPS |
| portal vein embolization + major liver resectionPVE on the first stage and major liver resection on the second stage | Procedure or surgery | Portal vein embolization (PVE) |
Primary outcome
Rate of Future Liver Remnant (FLR) Hypertrophy
Time frame: 10 days
Degree of FLR enlargement (%) with respect to initial volume of FLR [(Post-PVE FLR - Pre-PVE FLR) / (Pre-PVE FLR)] x 100
4 secondary outcomes
Major morbidity after the first stage
Time frame: 10 days
Blood loss
Time frame: intraoperative parameter
Major morbidity after the second stage
Time frame: 90 days
Liver failure
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Hilar Cholangiocarcinoma
Active, not recruitingPhase 2
Study of Chemotherapy, With or Without Binimetinib in Advanced Biliary Tract Cancers in 2nd Line Setting (A ComboMATCH Treatment Trial)
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Active, not recruitingPhase 3
Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)
Biliary Tract Cancer
Recruiting
Liver Transplantation for Non-resectable Perihilar Cholangiocarcinoma
Perihilar Cholangiocarcinoma, Klatskin Tumor
RecruitingPhase 2
Phase II Study of Neoadjuvant Tislelizumab Plus Radiotherapy and GP Chemotherapy for Borderline/Unresectable Hilar Cholangiocarcinoma
Cholangiocarcinoma, Hilar Cholangiocarcinoma
Recruiting
Suprapapillary Metal Stent vs. Routine Transpapillary Drainage in Malignant Hilar Biliary Obstruction (SMART-B Trial)
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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.
Mikhail Efanov principal investigator
Moscow Clinical Scientific Center
Questions about this trial
What is this clinical trial studying?
An observational study of Hilar Cholangiocarcinoma and Intrahepatic Cholangiocarcinoma, run by Moscow Clinical Scientific Center.
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 5 inclusion and 14 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: finished, as of the sponsor's last update on 25 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Future Liver Remnant (FLR) Hypertrophy (time frame: 10 days). 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 25 Oct 2017.