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NCT Number: NCT03320980

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).

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Key information

Conditions

Hilar Cholangiocarcinoma Adenocarcinoma Carcinoma Cholangiocarcinoma Intrahepatic Cholangiocarcinoma Klatskin Tumor Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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..

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RALPPS

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 + major liver resection

Procedure

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

Primary outcomes

  1. Rate of Future Liver Remnant (FLR) Hypertrophy

    Time frame: 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 outcomes

  1. Major morbidity after the first stage

    Time frame: 10 days

    Grade > II according to Clavien-Dindo classification

  2. Blood loss

    Time frame: intraoperative parameter

    Blood loss during second stage (major liver resection)

  3. Major morbidity after the second stage

    Time frame: 90 days

    Grade > II according to Clavien-Dindo classification

  4. Liver failure

    Time frame: 10 days

    Liver failure after the second stage according to criteria of International Study Group of Liver Surgery

Sponsors and collaborators

Lead sponsor

Moscow Clinical Scientific Center

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 25, 2017
Registry last updated
Oct 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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