Extent of Intrahepatic Infiltration of Perihilar Cholangiocarcinoma

April 10, 2024 updated by: Shuo Jin, Beijing Tsinghua Chang Gung Hospital

Pattern and Extent of Intrahepatic Infiltration of Perihilar Cholangiocarcinoma - A Liver Panoramic Digital Pathological Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 102218
        • Beijing Tsinghua Chang Gung Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients were diagnosed for PHCC based on clinical manifestations, imaging, and pathological findings. All patients 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 patients 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.

Description

Inclusion Criteria:

  1. Patients were diagnosed for PHCC based on clinical manifestations, imaging, and pathological findings.
  2. Hepatectomy was performed.
  3. WDLPS was successfully produced.

Exclusion Criteria:

  1. Not PHCC patients.
  2. Patients with PHCC did not undergo hepatectomy.
  3. WDLPS was not successfully produced.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
No RLI vs RLI
No RLI: PHCC patients without RLI. RLI: PHCC patients with RLI.
No DIHI vs DIHI
No DIHI: PHCC patients without DIHI. DIHI: PHCC patients with DIHI.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Relapse-free survival (RFS).
Time Frame: RFS as of December 2023
Refers to the survival time of a PHCC patient without recurrence of PHCC for a period of time after surgical treatment.
RFS as of December 2023

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall survival (OS).
Time Frame: OS as of December 2023
Refers to the time from the start of surgical treatment to death or the last follow-up of a PHCC patient.
OS as of December 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Tsinghua Chang Gung Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shuo Jin, PhD, Beijing Tsinghua Changgung Hospital affiliated to Tsinghua University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 13, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 22, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 22, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A01263

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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