Ignite Creation Date:
2024-05-06 @ 10:41 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03320980
Status:
COMPLETED
Last Update Posted:
2017-10-25
First Post:
2017-10-10
Brief Title:
RALPPS in Patients With Hilar and Intrahepatic Cholangiocarcinoma
Sponsor:
Moscow Clinical Scientific Center
Organization:
Moscow Clinical Scientific Center
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None