CholangiocarcinomaNCT03999593
Long-term Morbidity After Surgery for Perihilar Cholangiocarcinoma
An observational study of Cholangiocarcinoma and Surgery--Complications, run by University of Liverpool.
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.
- Conditions
- Cholangiocarcinoma, Surgery--Complications
- 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.
Perioperative morbidity
Clavien-Dindo complication index
Measured: 30 day
Secondary outcomes (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.
- First posted26 Jun 2019
- Study startJan 2009
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Jones, Principal investigator, University of Liverpool
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Morbidity After Surgery for Perihilar Cholangiocarcinoma; a Cohort Study
- ClinicalTrials.gov ID
- NCT03999593
- Acronym / sponsor ID
- 0001
- Conditions
- Cholangiocarcinoma, Surgery--Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Study start
- Jan 2009 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 26 Jun 2019 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- •Macroscopically complete resection of Bismuth 2-4 (peri)hilar cholangiocarcinoma with curative intent
Key exclusion criteria (3 listed)
- Metastatic disease
- Failure of curative intent resection (as per operating surgeon)
- Post resection histopathological diagnosis other than cholangiocarcinoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resection of perihilar cholangiocarcinomaResection of perihilar cholangiocarcinoma | Procedure or surgery | – |
Primary outcome
Perioperative morbidity
Time frame: 30 day
Clavien-Dindo complication index
1 secondary outcome
Perioperative morbidity
Time frame: 90 day
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 17 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Cholangiocarcinoma
Active, not recruitingObservational study
Liver Cancer Registry Platform
Hepatocellular Carcinoma (HCC), Cholangiocarcinoma
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
RecruitingPhase 3
D07001 Softgel-Capsules and Capecitabine Combination Therapy in Patients With Advanced Biliary Tract Cancer
Biliary Tract Cancer (BTC)
Not yet recruitingPhase 2
A Phase II Study of Single Tremelimumab With Regular Interval Durvalumab Plus Gemcitabine and Cisplatin in Locally Advanced Unresectable/Metastatic Combined Hepatocellular-cholangiocarcinoma
Combined Hepatocellular and Cholangiocarcinoma
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.
Robert Jones principal investigator
University of Liverpool
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.