An observational study in Hilar Cholangiocarcinoma and Intrahepatic Cholangiocarcinoma, sponsored by Moscow Clinical Scientific Center. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-10-25.
Sponsored by Moscow Clinical Scientific Center · Observational
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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).
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..
82 studies on the registry are indexed under Klatskin Tumor; 27 are open to participants now.
This study's enrollment of 30 is below the median of 200 across 23 observational studies indexed under Klatskin Tumor.
Browse Klatskin Tumor studies →Moscow Clinical Scientific Center is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
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Patients refered to the Center from other hospitals and primary care clinics
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
PVE on the first stage and major liver resection on the second stage
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
Time frame: 10 days
Major morbidity after the first stage
Grade \> II according to Clavien-Dindo classification
Time frame: 10 days
Blood loss
Blood loss during second stage (major liver resection)
Time frame: intraoperative parameter
Major morbidity after the second stage
Grade \> II according to Clavien-Dindo classification
Time frame: 90 days
Liver failure
Liver failure after the second stage according to criteria of International Study Group of Liver Surgery
Time frame: 10 days
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Sep 2014 to primary completion in Sep 2017, 36 months.
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This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Moscow Clinical Scientific Center