Clinical trial NCT03320980: RALPPS in Patients With Hilar and Intrahepatic Cholangiocarcinoma
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hilar Cholangiocarcinoma
Intrahepatic Cholangiocarcinoma
Keywords: ALPPS
RALPPS
Portal Vein Embolization
Hilar Cholangiocarcinoma
Intrahepatic Cholangiocarcinoma
Lead sponsor: Moscow Clinical Scientific Center
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients refered to the Center from other hospitals and primary care clinics

Brief 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. 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..

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Rate of Future Liver Remnant (FLR) Hypertrophy
timeFrame: 10 days
Secondary outcomes:
measure: Major morbidity after the first stage
timeFrame: 10 days
measure: Blood loss
timeFrame: intraoperative parameter
measure: Major morbidity after the second stage
timeFrame: 90 days
measure: Liver failure
timeFrame: 10 days
Other outcomes:
Locations:
Study officials:
affiliation: Moscow Clinical Scientific Center
name: Mikhail Efanov
role: PRINCIPAL_INVESTIGATOR
References: