Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06357117 |
Other study ID # |
A01263 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
April 13, 2018 |
Est. completion date |
December 22, 2021 |
Study information
Verified date |
April 2024 |
Source |
Beijing Tsinghua Chang Gung Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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 IVB+V 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 Fisher's exact
test. Continuous variables are presented in the form of mean±standard 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 26.0, SPSS Inc., IBM,
Armonk, NY, USA) and R (version 4.2.2.R Core Team.2022).