AzTrials
AzTrials

CholangiocarcinomaNCT03999593

Long-term Morbidity After Surgery for Perihilar Cholangiocarcinoma

An observational study of Cholangiocarcinoma and Surgery--Complications, run by University of Liverpool.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Cholangiocarcinoma, Surgery--Complications
What is being tested?
Resection of perihilar cholangiocarcinoma
Type of treatment
Surgery or procedure
How many people
60 participants
Where
No sites listed yet
Study dates
Jan 2009to Oct 2017
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

About this study

Official title: 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.

Read the 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.

Being tested
Resection of perihilar cholangiocarcinoma
Medical subject headings
Cholangiocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resection of perihilar cholangiocarcinomaProcedure or surgery

    Resection of perihilar cholangiocarcinoma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perioperative morbidity

    Clavien-Dindo complication index

    Measured: 30 day

Secondary outcomes (1)
  1. Perioperative morbidity

    Clavien-Dindo complication index

    Measured: 90 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2019
  2. Study startJan 2009
  3. Primary completionOct 2017
  4. Study completionOct 2017

Resources

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
Cohort
Time perspective
Retrospective
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03999593
Sponsor's protocol ID
0001
Status last verified
Dec 2024
First submitted
21 Jun 2019
Last updated
17 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cholangiocarcinoma and Surgery--Complications, run by University of Liverpool.

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 1 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 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Perioperative morbidity (time frame: 30 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 17 Dec 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in