RALPPS in Patients With Hilar and Intrahepatic Cholangiocarcinoma

Completed

• Conditions: Hilar Cholangiocarcinoma; Intrahepatic Cholangiocarcinoma
• Interventions: Procedure: portal vein embolization + major liver resection; Procedure: RALPPS

• Registration Number: NCT03320980
• Lead Sponsor: Moscow Clinical Scientific Center

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..

Study Timeline

• Study Start: 2014-09-15
• Primary Completion: 2017-09-20
• Status Verified: 2017-10
• Study Completion: 2017-10-01
• Study First Submitted: 2017-10-10
• Study First Submitted QC: 2017-10-24
• Last Update Submitted: 2017-10-24
• Study First Posted: 2017-10-25
• Last Update Posted: 2017-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Portal vein embolization (PVE)	portal vein embolization + major liver resection	Patients with initial volume of FLR \< 40% undergoing PVE and major liver resection for hilar and intrahepatic cholangiocarcinoma
RALPPS	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Blood loss	intraoperative parameter	Blood loss during second stage (major liver resection)
Major morbidity after the first stage	10 days	Grade \> II according to Clavien-Dindo classification
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