Long-term Morbidity After Surgery for Perihilar Cholangiocarcinoma

December 13, 2024 updated by: University of Liverpool

Long-term Morbidity After Surgery for Perihilar Cholangiocarcinoma; a Cohort Study

Surgery for perihilar cholangiocarcinoma offers the only possibility of long-term survival, but remains a formidable undertaking. Traditionally, 90 day post-operative complications and death have been used to define operative risk. However, there is concern that this metric may not accurately capture long-term morbidity after such complex surgery.

This is a retrospective review of a prospective database of patients undergoing surgery for perihilar cholangiocarcinoma at a Western centre between 2009-2017.

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Cholangiocarcinoma is an uncommon cancer, but is the second commonest primary hepatic tumour after hepatocellular carcinoma. Its incidence is rising globally with 1200 cases per year in England & Wales. Tumours may originate within the liver itself, although the majority arise at the confluence of the hepatic ducts (perihilar tumours). Surgery is the only potentially curative treatment, but remains a formidable undertaking usually requiring a major liver resection to achieve the clear surgical margins that are essential for long-term survival, followed by complex biliary reconstruction. The magnitude of this surgery is reflected in an operative mortality reported between 10-15% in most Western centres. In addition, almost half the patients suffer major complications prior to discharge from hospital.

Following such surgery, around 30-40% of patients are alive after 5 years. However, a significant minority succumb to rapid disease recurrence, with a third dying within the first year after resection. Although offering no hope of cure, systemic chemotherapy with cisplatin/gemcitabine offers a median overall survival of 11.7 months. For patients planned to undergo surgery, but found to have locally advanced and therefore irresectable disease at laparotomy, median survival with palliative chemotherapy can reach 16 months with 10% of patients alive 3 years later. It therefore seems likely that a proportion of patients undergo major surgery, at significant risk of immediate postoperative mortality or morbidity, when they may be better served by systemic chemotherapy.

Operative morbidity and mortality has traditionally been reported as death or complication occurring within the first 30 days after surgery. However, it is now clear that this 30-day cut-off underestimates the morbidity and mortality after hepatic resection with ninety-day morbidity and mortality increasingly recognised as a more appropriate measure of postoperative outcome after liver surgery. There is also a lack of evidence on the impact that contemporary enhanced recovery after surgery (ERAS) programmes may have on these outcomes.

The unique characteristics of the complex and demanding surgery required for resection of this disease means there is also a possibility of long-term complications beyond 90-days. To date, the long-term morbidity after resection has not been reported. These data are essential to allow patients to make fully informed decisions around the risks and benefits of surgery.

This study therefore aimed to characterise the long-term morbidity after resection of perihilar cholangiocarcinoma managed with an ERAS programme in a Western centre.

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.
60

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing resection for perihilar cholangiocarcinoma at University Hospital Aintree between January 2009 and October 2017 were identified using a prospectively maintained database.

Description

Inclusion Criteria:

•Macroscopically complete resection of Bismuth 2-4 (peri)hilar cholangiocarcinoma with curative intent

Exclusion Criteria:

  • Metastatic disease
  • Failure of curative intent resection (as per operating surgeon)
  • Post resection histopathological diagnosis other than cholangiocarcinoma

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

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
Perioperative morbidity
Time Frame: 30 day
Clavien-Dindo complication index
30 day

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
Perioperative morbidity
Time Frame: 90 day
Clavien-Dindo complication index
90 day

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.
University of Liverpool

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: Robert Jones, University of Liverpool

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.
January 1, 2009

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.
October 1, 2017

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.
October 1, 2017

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).
June 21, 2019

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.
June 25, 2019

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.
June 26, 2019

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.
March 25, 2025

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.
December 13, 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.
December 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.
  • 0001 (Researcher)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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