RALPPS in Patients With Hilar and Intrahepatic Cholangiocarcinoma

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).

Study Overview

• Status: Completed
• Conditions: Intrahepatic Cholangiocarcinoma; Hilar Cholangiocarcinoma
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients refered to the Center from other hospitals and primary care clinics

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	10 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Moscow Clinical Scientific Center
• Investigators: Principal Investigator: Mikhail Efanov, Moscow Clinical Scientific Center

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2014
• Primary Completion (Actual): September 20, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: October 10, 2017
• First Submitted That Met QC Criteria: October 24, 2017
• First Posted (Actual): October 25, 2017

Study Record Updates

• Last Update Posted (Actual): October 25, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Hilar Cholangiocarcinoma; ALPPS; Intrahepatic Cholangiocarcinoma; RALPPS; Portal Vein Embolization
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Cholangiocarcinoma; Klatskin Tumor
• Other Study ID Numbers: MCNC 09/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No