RALPPS in Patients With Hilar and Intrahepatic Cholangiocarcinoma

Sponsor

Moscow Clinical Scientific Center (Other)

Overall Status

Completed

CT.gov ID

NCT03320980

Collaborator

(none)

Enrollment

36.5

Actual Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Hilar Cholangiocarcinoma Intrahepatic Cholangiocarcinoma	Procedure: RALPPS Procedure: portal vein embolization + major liver resection

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

Study Type:

Observational

Actual Enrollment :

30 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

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

Actual Study Start Date :

Sep 15, 2014

Actual Primary Completion Date :

Sep 20, 2017

Actual Study Completion Date :

Oct 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
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	Procedure: RALPPS 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 (PVE) Patients with initial volume of FLR < 40% undergoing PVE and major liver resection for hilar and intrahepatic cholangiocarcinoma	Procedure: portal vein embolization + major liver resection PVE on the first stage and major liver resection on the second stage

Arm

Intervention/Treatment

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

Procedure: RALPPS

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 (PVE)

Patients with initial volume of FLR < 40% undergoing PVE and major liver resection for hilar and intrahepatic cholangiocarcinoma

Procedure: portal vein embolization + major liver resection

PVE on the first stage and major liver resection on the second stage

Outcome Measures

Primary Outcome Measures

Rate of Future Liver Remnant (FLR) Hypertrophy [10 days]
Degree of FLR enlargement (%) with respect to initial volume of FLR [(Post-PVE FLR - Pre-PVE FLR) / (Pre-PVE FLR)] x 100

Secondary Outcome Measures

Major morbidity after the first stage [10 days]
Grade > II according to Clavien-Dindo classification
Blood loss [intraoperative parameter]
Blood loss during second stage (major liver resection)
Major morbidity after the second stage [90 days]
Grade > II according to Clavien-Dindo classification
Liver failure [10 days]
Liver failure after the second stage according to criteria of International Study Group of Liver Surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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