Clinical trial · Observational
RALPPS in Patients With Hilar and Intrahepatic Cholangiocarcinoma
Split-in-situ Resection With Radio-frequency Ablation Instead of Liver Partition on the First Stage (RALPPS) in Patients With Hilar and Intrahepatic Cholangiocarcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hilar Cholangiocarcinoma | Hilar Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Intrahepatic Cholangiocarcinoma | Intrahepatic Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| portal vein embolization + major liver resection | Procedure | — | UNRESOLVED |
| RALPPS | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- RALPPS
- description
- 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
- interventionNames
- Procedure: RALPPS
- label
- Portal vein embolization (PVE)
- description
- Patients with initial volume of FLR \< 40% undergoing PVE and major liver resection for hilar and intrahepatic cholangiocarcinoma
- interventionNames
- Procedure: portal vein embolization + major liver resection
Primary outcomes (1)
- measure
- Rate of Future Liver Remnant (FLR) Hypertrophy
- timeFrame
- 10 days
- description
- Degree of FLR enlargement (%) with respect to initial volume of FLR \[(Post-PVE FLR - Pre-PVE FLR) / (Pre-PVE FLR)\] x 100
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available