Perihilar CholangiocarcinomaNCT06357117
Extent of Intrahepatic Infiltration of Perihilar Cholangiocarcinoma
An observational study of Perihilar Cholangiocarcinoma, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 44 to 81 years
- Conditions the study is for
- Perihilar Cholangiocarcinoma
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 13 Apr 2018to 22 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 44 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients were diagnosed for PHCC based on clinical manifestations, imaging, and pathological findings.
- Hepatectomy was performed.
- WDLPS was successfully produced.
Who cannot join
- Not PHCC patients.
- Patients with PHCC did not undergo hepatectomy.
- WDLPS was not successfully produced.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tsinghua Chang Gung Hospital
Beijing, Beijing Municipality, 102218
About this study
Official title: 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.
Read the 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).
- Conditions
- Perihilar Cholangiocarcinoma
- Medical subject headings
- Klatskin Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Relapse-free survival (RFS).
Refers to the survival time of a PHCC patient without recurrence of PHCC for a period of time after surgical treatment.
Measured: RFS as of December 2023
Secondary outcomes (1)
Overall survival (OS).
Refers to the time from the start of surgical treatment to death or the last follow-up of a PHCC patient.
Measured: OS as of December 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start13 Apr 2018
- Primary completion22 Dec 2021
- Study completion22 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perihilar CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuo Jin, Beijing Tsinghua Chang Gung Hospital
- Investigators
- Shuo Jin, PhD, Principal investigator, Beijing Tsinghua Changgung Hospital affiliated to Tsinghua University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357117
- Sponsor's protocol ID
- A01263
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
Jin S, Jiang N, Zhao JM, Xiao Y, Wang SY, Xiang CH, Lu Q, Shan SQ, Ruan HT, Yu SQ, Zeng JP, Yang SZ, Li L, Dong JH. Pattern and extent of intrahepatic infiltration of perihilar cholangiocarcinoma - a case-control study based on liver panoramic digital pathology. Int J Surg. 2025 Jan 1;111(1):31-39. doi: 10.1097/JS9.0000000000002040.
PubMed 39166939
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern and Extent of Intrahepatic Infiltration of Perihilar Cholangiocarcinoma - A Liver Panoramic Digital Pathological Study
- ClinicalTrials.gov ID
- NCT06357117
- Acronym / sponsor ID
- A01263
- Conditions
- Perihilar Cholangiocarcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 13 Apr 2018 (actual)
- Primary completion
- 22 Dec 2021 (actual)
- Study completion
- 22 Dec 2021 (actual)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 44 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients were diagnosed for PHCC based on clinical manifestations, imaging, and pathological findings.
- Hepatectomy was performed.
- WDLPS was successfully produced.
Key exclusion criteria (3 listed)
- Not PHCC patients.
- Patients with PHCC did not undergo hepatectomy.
- WDLPS was not successfully produced.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Overall survival (OS).
Time frame: OS as of December 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Derived from this study: PubMed 39166939Jin S, Jiang N, Zhao JM, Xiao Y, Wang SY, Xiang CH, Lu Q, Shan SQ, Ruan HT, Yu SQ, Zeng JP, Yang SZ, Li L, Dong JH. Pattern and extent of intrahepatic infiltration of perihilar cholangiocarcinoma - a case-control study based on liver panoramic digital pathology. Int J Surg. 2025 Jan 1;111(1):31-39. doi: 10.1097/JS9.0000000000002040.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shuo Jin, PhD principal investigator
Beijing Tsinghua Changgung Hospital affiliated to Tsinghua University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perihilar Cholangiocarcinoma, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse-free survival (RFS). (time frame: RFS as of December 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06357117, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.