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RALPPS in Patients With Hilar and Intrahepatic Cholangiocarcinoma

NCT ID: NCT03320980

Last Updated: 2017-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-15

Study Completion Date

2017-10-01

Brief Summary

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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

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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..

Conditions

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Hilar Cholangiocarcinoma Intrahepatic Cholangiocarcinoma

Keywords

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ALPPS RALPPS Portal Vein Embolization Hilar Cholangiocarcinoma Intrahepatic Cholangiocarcinoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

RALPPS

Intervention Type PROCEDURE

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

portal vein embolization + major liver resection

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

portal vein embolization + major liver resection

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Moscow Clinical Scientific Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mikhail Efanov

Role: PRINCIPAL_INVESTIGATOR

Moscow Clinical Scientific Center

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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MCNC 09/2017

Identifier Type: -

Identifier Source: org_study_id