NCT03320980

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2014

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2017

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 25, 2017

Completed
Last Updated

October 25, 2017

Status Verified

October 1, 2017

Enrollment Period

3 years

First QC Date

October 10, 2017

Last Update Submit

October 24, 2017

Conditions

Hilar CholangiocarcinomaIntrahepatic Cholangiocarcinoma

Keywords

ALPPSRALPPSPortal Vein EmbolizationHilar CholangiocarcinomaIntrahepatic Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Major morbidity after the first stage

    10 days

  • Blood loss

    intraoperative parameter

  • Major morbidity after the second stage

    90 days

  • Liver failure

    10 days

Study Arms (2)

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

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

Interventions

RALPPSPROCEDURE

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

RALPPS
portal vein embolization + major liver resectionPROCEDURE

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

Portal vein embolization (PVE)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Klatskin TumorCholangiocarcinoma

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Mikhail Efanov

    Moscow Clinical Scientific Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2017

First Posted

October 25, 2017

Study Start

September 15, 2014

Primary Completion

September 20, 2017

Study Completion

October 1, 2017

Last Updated

October 25, 2017

Record last verified: 2017-10