Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06357117
Status:
COMPLETED
Last Update Posted:
2024-04-11
First Post:
2024-04-04
Brief Title:
Extent of Intrahepatic Infiltration of Perihilar Cholangiocarcinoma
Sponsor:
Beijing Tsinghua Chang Gung Hospital
Organization:
Beijing Tsinghua Chang Gung Hospital
Study Overview
Official Title:
Pattern and Extent of Intrahepatic Infiltration of Perihilar Cholangiocarcinoma - A Liver Panoramic Digital Pathological Study
Status:
COMPLETED
Status Verified Date:
2024-04
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:
The extent of intrahepatic infiltration of perihilar cholangiocarcinoma PHCC remains unclear This research aimed to explore the pattern and extent of intrahepatic infiltration of PHCC to guide surgical treatment and pathological research This prospective study included 62 participants diagnosed with PHCC who underwent major hepatectomy A whole-mount digital liver pathology system WDLPS for hepatectomy specimens greater than 10 10 cm was used to panoramically assess the intrahepatic infiltration extent of PHCC
Detailed Description:
Perihilar cholangiocarcinoma PHCC is the most common type of bile duct malignancy and radical surgical resection is the most effective treatment The extent and characteristics of the intrahepatic infiltration of PHCC remain unclear leading to controversy about the extent of liver resection for PHCC The expert consensus statement of PHCC recommends tumor-invaded lobectomy as the standard procedure for liver resection however many studies recommend major hepatectomy hemihepatectomy or trisectionectomy Recently minor hepatectomy has emerged for PHCC such as resection of segment IVBV and perihilar combined with segment I resection however the efficacy remains controversial To determine the extent and characteristics of intrahepatic infiltration of PHCC the investigators constructed a whole-mount digital liver pathology system WDLPS that allows the tumor and surrounding liver tissue from major hepatectomy specimens to be displayed in one large section which could localize the margin of the main tumor and observe the distribution of adenocarcinoma panoramically In addition digital measurement was used to accurately measure the range of intrahepatic infiltration to guide the scope of hepatectomy From April 2018 to December 2021 62 participants were diagnosed for PHCC based on clinical manifestations imaging and pathological findings All participants underwent hemihepatectomy or trisectionectomy combined with caudate lobectomy Skeletonization resection of the hepatoduodenal ligament including dissection of the regional lymph nodes was performed from the duodenum to the liver Clinical and pathological indicators of the participants were collected Portal vein and hepatic artery invasion were defined as the primary or secondary branch in the resected side or the reserved side which was invaded In this study the investigators established a WDLPS to study the intrahepatic invasion range and pathway of PHCC through the major hepatectomy specimens panoramically The distal intrahepatic infiltration DIHI and radial liver invasion RLI were important components of intrahepatic infiltration of PHCC explored by WDLPS RLI distance was defined as the maximum straight-line distance from the infiltrated liver parenchyma to the hepatic hilar plate DIHI was defined as the intrahepatic infiltration greater than 1 cm from the margin of the main tumor The distance between the DIHI and the margin of the main tumor was recorded Categorical variables are expressed as percentages and the difference were tested using the chi-squared test or Fishers exact test Continuous variables are presented in the form of meanstandard deviation and were tested using the t-test or Mann-Whitney U test when appropriate Relapse-free survival RFS and Overall survival OS were estimated using the Kaplan-Meier method and differences between groups were assessed by the log-rank test In addition the investigators estimated restricted mean survival time RMST without a truncation time and RMST differences ΔRMSTs for RFS and OS between treatment groups to provide clinically relevant intuitive estimation Statistical analyses were performed using the SPSS software version 260 SPSS Inc IBM Armonk NY USA and R version 422R Core Team2022
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