Status:
COMPLETED
RALPPS in Patients With Hilar and Intrahepatic Cholangiocarcinoma
Lead Sponsor:
Moscow Clinical Scientific Center
Conditions:
Hilar Cholangiocarcinoma
Intrahepatic Cholangiocarcinoma
Eligibility:
All Genders
18-80 years
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 sh...
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 lo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 15 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03320980
Start Date
September 15 2014
End Date
October 1 2017
Last Update
October 25 2017
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