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出境医 / 临床实验 / Long-term Morbidity After Surgery for Perihilar Cholangiocarcinoma

Long-term Morbidity After Surgery for Perihilar Cholangiocarcinoma

Study Description
Brief 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. 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.


Condition or disease Intervention/treatment
Cholangiocarcinoma Surgery--Complications Procedure: Resection of perihilar cholangiocarcinoma

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
Layout table for study information
Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Long-term Morbidity After Surgery for Perihilar Cholangiocarcinoma; a Cohort Study
Actual Study Start Date : January 2009
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Perioperative morbidity [ Time Frame: 30 day ]
    Clavien-Dindo complication index


Secondary Outcome Measures :
  1. Perioperative morbidity [ Time Frame: 90 day ]
    Clavien-Dindo complication index


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date June 21, 2019
First Posted Date June 26, 2019
Last Update Posted Date July 1, 2019
Actual Study Start Date January 2009
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 25, 2019)
Perioperative morbidity [ Time Frame: 30 day ]
Clavien-Dindo complication index
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 25, 2019)
Perioperative morbidity [ Time Frame: 90 day ]
Clavien-Dindo complication index
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Long-term Morbidity After Surgery for Perihilar Cholangiocarcinoma
Official Title Long-term Morbidity After Surgery for Perihilar Cholangiocarcinoma; a Cohort Study
Brief 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. 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Cholangiocarcinoma
  • Surgery--Complications
Intervention Procedure: Resection of perihilar cholangiocarcinoma
Resection of perihilar cholangiocarcinoma
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 25, 2019)
60
Original Actual Enrollment Same as current
Actual Study Completion Date October 2017
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03999593
Other Study ID Numbers 0001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Robert Jones, University of Liverpool
Study Sponsor University of Liverpool
Collaborators Not Provided
Investigators
Principal Investigator: Robert Jones University of Liverpool
PRS Account University of Liverpool
Verification Date June 2019