RALPPS in Patients With Hilar and Intrahepatic Cholangiocarcinoma

Intrahepatic Cholangiocarcinoma Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03320980
• Other study ID #: MCNC 09/2017
• Status: Completed
• Phase: N/A
• First received: October 10, 2017
• Last updated: October 24, 2017
• Start date: September 15, 2014
• Est. completion date: October 1, 2017

Study information

• Verified date: October 2017
• Source: Moscow Clinical Scientific Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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 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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 1, 2017
• Est. primary completion date: September 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Hilar Cholangiocarcinoma
• Intrahepatic Cholangiocarcinoma
• Klatskin Tumor

Intervention

Procedure:
• 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
• portal vein embolization + major liver resection
PVE on the first stage and major liver resection on the second stage

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Moscow Clinical Scientific Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Major morbidity after the first stage	Grade > II according to Clavien-Dindo classification	10 days
Secondary	Blood loss	Blood loss during second stage (major liver resection)	intraoperative parameter
Secondary	Major morbidity after the second stage	Grade > II according to Clavien-Dindo classification	90 days
Secondary	Liver failure	Liver failure after the second stage according to criteria of International Study Group of Liver Surgery	10 days