Split-in-situ Resection With Radio-frequency Ablation Instead of Liver Partition on the First Stage (RALPPS) in Patients With Hilar and Intrahepatic Cholangiocarcinoma
Conditions: Hilar Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma
Sponsor: Moscow Clinical Scientific Center

Study Protocol 
 
 
Title of the study: Split-in-situ Resection With Radio-frequency Ablation Instead 
of Liver Partition on the First Stage (RALPPS) in Patients With Hilar and 
Intrahepatic Cholangiocarcinoma 
 
Unic Protocol ID: MCNC 09/2017 
 
Date: October 24, 2017 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Background: 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. 
Study design: retrospective observational case-control study.  
The purpose of the study: comparison of short-term results of RALPPS and 
portal vein embolization (PVE) in patients with hilar (h-CCA) and intrahepatic (i-
CCA) cholangiocarcinoma. 
Material and Methods: two groups will be compared. 
Group 1: patients with h-CCA and i-CCA underwent RALPPS. 
Group 2: patients with h-CCA and i-CCA underwent PVE. 
 
Inclusion Criteria: patients with h-CCA and i-CCA which are the candidates for 
radical treatment (intention to R0 resection) using major liver resection with 
volume of future liver remnant (FLR) less than 40%.    
 
Indication for RALPPS/PVE. 
 h-CCA, type II-IV, T1-3N0-1M0, volume of FLR<40% 
 i-CCA, T1-3N0-1M0, volume of FLR<40% 
 
Contraindication for RALPPS/PVE. 
 h-CCA, stage IVA, B 
 i-CCA, stage IVB 
 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 
 
Inclusion Criteria 
 Gender: both, male and female 
 Minimum age 18 years 
 Maximum age: 80 years 
 
Exclusion Criteria 
 Age under 18 years  
 Age above 80 years  
 Persons who are incapable of giving consent 
 Pregnant or breast-feeding women 
 

Preoperative examination:  
1. Abdominal ultrasound examination,  
2. Abdominal enhanced CT (with or without MRI and MRCP), 
3. Direct cholangiography, 
4. Chest CT,  
5. The upper digestive tract endoscopic examination,  
6. Colonoscopy (if it is absent over the past year),  
7. Tumor markers (CEA and CA 19-9). 
 
 
Comparative analysis should include following intraoperative and postoperative 
factors 
 
Primary endpoint: rate of FLR hypertrophy (%). 
The standard formula for calculation the rate of hypertrophy: 
[(Post-PVE FLR – Pre-PVE FLR) / (Pre-PVE FLR)] x 100  
 
Secondary endpoints: 
1. Morbidity after stage 1 (according to Clavien-Dindo classification, 
attachment 1) 
2. Morbidity after stage 2 
3. Blood loss (during stage 2) 
4. Duration of hospital stay 
 
Bile leakage will be classified in severity according to the international study 
group for liver surgery (attachment 2). 
Posthepatectomy liver failure was estimated according to the international study 
group for liver surgery (attachment 3). 
 
 
The number of patients for primary estimation of short-term results consist of 10 
patients in RALPPS group and 20 patients in group of PVE. If preliminary results 
reveal tendency to better results of RALPPS in terms of FLR hypertrophy and 
confirm safety of RALPPS the number of patients will be increased to 60 (30 
patients in each group). 
 
Mikhail Efanov, MD, PhD, 
Head of the HepatoPancreatoBiliary 
Surgery Department, 
Moscow Clinical Scientific Center 
+7(916) 105-88-30 
www.mknc.ru 
 
 

Attachments 1  
 
Clavien PA, Barkun J, de Oliveira ML, et al. The Clavien-Dindo classification of surgical 
complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 
10.1097/SLA.0b013e3181b13ca2. 
 
Attachments 2 
Bile leakage 
Bile leakage grade A: Grade A bile leakage has little or no impact on patients’ 
clinical management. 
Bile leakage grade B: A bile leakage requiring a change in patients’ clinical 
management but can be treated without relaparotomy. 
Bile leakage grade C: Patients with a Grade C bile leakage require relaparotomy to 
control this complication. 
 
Koch M, Garden OJ, Padbury R, et al. Bile leakage after hepatobiliary and pancreatic surgery: a 
definition and grading of severity by the International Study Group of Liver Surgery. Surgery. 
2011 May;149(5):680-8. doi: 10.1016/j.surg.2010.12.002. Epub 2011 Feb 12. 
 

Attachments 3 
Posthepatectomy liver failure 
 
Grade A posthepatectomy liver failure: Grade A PHLF represents a postoperative 
deterioration of liver function that does not require a change in the patient’s 
clinical management. 
Grade B posthepatectomy liver failure: Patients are diagnosed with grade B PHLF 
if there is a deviation from the regular, postoperative clinical pathway, but they can 
be managed without invasive treatment. 
Grade C posthepatectomy liver failure: Patients who develop PHLF requiring an 
invasive procedure are classified as having grade C PHLF. 
 
Rahbari NN, Garden OJ, Padbury R, et al. Posthepatectomy liver failure: 
a definition and grading by the International Study Group of Liver Surgery (ISGLS).Surgery. 
2011 May;149(5):713-24. doi: 10.1016/j.surg.2010.10.001. Epub 2011 Jan 14.