Site specific - Liver and cholangiocarcinoma

This data set includes both the collection of Liver and Cholangiocarcinoma data items. Some data will continue to be part of the Cancer Waiting Times (Site Specific Group of Upper GI), but for COSD, they will now be reported within the Liver data set.

It is important that MDT Coordinators understand through specific training (if required), that all data within the Liver section of COSD are applicable to Cholangiocarcinoma. The only exception is LV16100 (Barcelona Clinic Liver Cancer (BCLC) Stage), which cannot be collected for Cholangiocarcinoma.

Notes:

• data item LV16400 (Cholangiocarcinoma Category) must be completed for all cholangiocarcinoma diagnoses, this will help accurately identify the precise Cholangiocarcinoma diagnosed (Intrahepatic, Perihilar or Extrahepatic)
• if in doubt, please discuss this with your specialist consultant within the MDT

You can use an online version of the HCC staging calculator.

ICD-10 codes

• please refer to Appendix A and B for site specific registerable ICD codes for liver and cholangiocarcinoma cancer patients

This is a child of 'CORE – Diagnosis' group
May be up to one occurrence per CORE – Diagnosis (0..1)

Start of Repeating Item - Cause of Liver Cirrhosis

End of Repeating Item - Cause of Liver Cirrhosis

Liver Surveillance Scans

Has the patient had regular 6 monthly liver ultrasound scans for the purpose of early detection of HCC?

Additional information:
This information will normally be available in the patient record.

Rationale for inclusion:
Individuals with cirrhosis are at increased risk of developing HCC (the annual incidence of HCC is approximately 3% in cirrhotic patients). Detection by ultrasound surveillance is associated with improved outcomes in patients diagnosed with HCC.

Liver Cirrhosis Type

Record the type of liver cirrhosis.

Additional information:
Presence of cirrhosis can be defined by previous clinical assessments, current imaging findings, or histopathology before/after treatment. If cirrhosis is present, it can be compensated or decompensated. Decompensation describes the inability of the liver to carry out its usual functions and is marked by the presence of ascites, hepatic encephalopathy, or variceal bleeding this information will normally be available in the patient record. If cirrhosis is not decompensated, it is compensated.

Rationale for inclusion:
Approximately 80% of HCC occurs in individuals with cirrhosis and cirrhosis is also a risk factor for cholangiocarcinoma. HCC-related outcomes are different for individuals with and without cirrhosis.

When decompensation is present treatment options for HCC are limited. The presence of advanced liver disease has a strong influence on prognosis in addition to that of the cancer.

Cause of Liver Cirrhosis

Record if the patient's liver cirrhosis is caused by known risk factors for liver disease. Select all that apply. This is a multiple repeating data item.

Additional information:
This information will normally be available in the patient record.
These additional core items should also be completed:

• alcohol use
• smoking
• body mass index

Rationale for inclusion:
The cause of cirrhosis is associated with different levels of risk for HCC and also with different rates of progression in the underlying liver disease. These factors are important for determining overall treatment and prognosis. Multiple causes can be selected.

This section is a child of ‘CORE – Diagnosis'
May be up to one occurrence per CORE - Diagnosis (0..1)

Start of Repeating Item - Cholangiocarcinoma Risk Factors Type

End of Repeating Item - Cholangiocarcinoma Risk Factors Type

Cholangiocarcinoma Category

Where applicable, this is a mandatory data item. This is to help identify the individual components of Cholangiocarcinoma. State where the Cholangiocarcinoma is present, using the designated categories. Any cholangiocarcinoma which involves the anatomical hilum of the liver must be classified as perihilar.

Additional information:

• intrahepatic cholangiocarcinoma’s are those arising above the second order bile ducts
• extrahepatic are those arising below the cystic duct
• perihilar are those arising in-between

Cholangiocarcinoma Risk Factors Type

This is a new data item for v10. Record any additional risk factors that are associated with the cholangiocarcinoma diagnosis

It is important that all stageable cancers are staged for every case. All site specific staging fields are mandatory and a child of ‘CORE – Site Specific Staging’ Section, and together mandates the collection of:

• the date the sample was taken which provided a positive site specific stage outcome or the MDT where the stage was agreed
• the organisation who carried out the stage
  • this is a ‘required’ data item from v10, but important to collect if known
• the stage itself

A calculator designed to help with completion of the following items can be found here.
May be up to one occurrence per CORE - Site Specific Staging (1..1)

Barcelona Clinic Liver Cancer (BCLC) Stage

Where applicable, this is a mandatory data item. The Barcelona Clinic Liver Cancer (BCLC) Stage includes both anatomic and non-anatomic factors and is widely used worldwide to predict prognosis and determine treatment. This item should only be completed for hepatocellular carcinomas (C220).

Additional information:

• the stage calculated closest to diagnosis should be recorded, three separate pieces of clinical information are required
• ECOG Performance Status, this is a measure of the persons functional status from 0 (fully active) to 4 (completely disabled)
• severity of underlying liver diseases measured by the Child-Pugh score that includes both blood test (bilirubin, albumin and INR) and clinical parameters (ascites and encephalopathy)
• cancer burden, the definition of cancer burden here is different to that described by the TNM staging system
• information normally available in the patient record and on review of imaging at MDT

You can use the online calculator for both of these parameters that will also calculate the LCLC stage.

Rationale for inclusion:
The BCLC staging system integrates information on performance status, liver function, and cancer burden to identify likely treatment options and to guide prognosis. This information is different to that contained in the TNM staging system and, for persons with HCC, BCLC is more predictive of outcome.
It is important that core TNM staging information (CR0520, CR0540, CR0560, CR0580, CR3120 & CR0620, CR0630, CR0640, CR0610, CR3130) are also completed. The Alpha-fetoprotein (AFP) should also be provided, if known (item no. CR8920).

May be up to one occurrence per record (0..1)

Note:

• these indicators should be collected only once and as close to the point of diagnosis as possible

Portal Invasion

Record whether there is tumour present in the main portal vein, or if there is tumour present in a branch of the portal vein or if there is no tumour present in the portal vein.

Additional information:

• this information is available from imaging review
• ‘1’ and ‘2’ have a new national code definitions – previously ‘Branch’ and ‘Main’

Rationale for inclusion:
Tumour’s invasion of large vessels (macrovascular invasion) occurs in different locations. Treatment options may vary by the location of vascular invasion.

UKELD Score

Record the UKELD score (range 0-99). The UKELD score is calculated using bilirubin, INR, creatinine and sodium. The UKELD score predicts the risk of mortality due to liver cirrhosis and is used to assess need for liver transplantation.

UKELD calculation is included in the calculator available from the British Association for the Study of Liver website.

Rationale for inclusion:
UKELD is a score that indicates prognosis for persons with cirrhosis. It provides an assessment of predicted mortality from liver disease over the following year.

Child-Pugh Score

Record the overall Child-Pugh score. This is the level of disease of the liver.

This section is a child of CORE – Treatment and will mandate:

• the date the treatment started
• the treatment modality
• the organisation that provided the treatment

It is possible that some legacy data may not have all the required mandatory fields. The recommendation is for Trusts to update their data to meet the new requirements and improve/enrich their data submissions, or not upload the legacy data items in the new record (if that data is not available).

May be up to one occurrence per Core - Treatment (0..1)

Ablative Therapy Type

Describe type of ablative (such as locally destructive treatment) therapy used if any.

Notes:

• ‘S – Stereotactic ablative radiotherapy (SABR), is new in v10
• Stereotactic Body Radiotherapy (SBRT) is another term that can be frequently used in place of SABR
• ‘8 - Other ablative treatment’ has been retired from v10 and replaced with ‘7 - Other ablative therapy’

Rationale for inclusion:

• ablation treatment is used with curative intent for persons with early stage disease (BCLC-0/A)
• the option chosen will depend on the size of the cancer being treated, how close the cancer is to other structures, and local experience and expertise
• for each ablative therapy treatment, there should be a corresponding treatment record created in CORE - Treatment, with the correct treatment modality, date of treatment and organisation code recorded

Embolisation Modality

What modality of the ‘Liver Trans Arterial Embolisation’ was used?

Notes:

• ‘2 – C-TACE’ has a been retired in v10 and replaced with ‘6 – TACE’
• ‘5’ has a new national code definition – previously ‘SIRT’

This refers to the type of material injected into the hepatic artery:

• TAE/BLAND - Transarterial Embolism, Embolic agents such as coils or foam only
• DEB-TACE - drug eluting beads coated with chemotherapy
• RO DEB-TACE - radiopaque drug eluting beads loaded with chemotherapy
• SIRT/TARE/Radioembolisation - Transarterial radioembolization or Selective internal radiation therapy (Y90 radio-embolisation)
• TACE - Transarterial chemo-embolisation, chemotherapy plus embolic agents such as coils or foam

Embolisation can be done in 3 ways:

• without chemotherapy or radiotherapy - so called “Bland” embolisation or TAE
• with chemotherapy – TACE
• with local radiotherapy – so called selective internal radiotherapy (SIRT) or transarterial radioembolization (TARE)

If chemoembolisation is done, the following methods can be used:

• standard chemotherapy – “TACE”
• drug eluting beads – “DEB-TACE”
• radio-opaque drug eluting beads – “RO DEB-TACE”

Information normally available in the patient record within the radiology reports of the procedure.

For each embolisation delivered, there should be a corresponding treatment record created in CORE-Treatment, with the correct treatment modality, date of treatment and organisation code recorded.

Rationale for inclusion:
There are different types of embolisation that are used in different circumstances and according to local expertise and practices.

This section is a child of ‘CORE – Treatment’ and will mandate:

• the date the treatment started
• the treatment modality
• the organisation that provided the treatment

It is possible that some legacy data may not have all the required mandatory fields. The recommendation is for Trusts to update their data to meet the new requirements and improve/enrich their data submissions, or not upload the legacy data items in the new record (if that data is not available).

May be up to one occurrence per CORE – Treatment – Surgery (0..1)

Surgery Type

What type of liver surgery was performed?

Additional information:
Was it either a liver resection (where a part of the liver is removed) or a liver transplant? This information is available from imaging review.

Rationale for inclusion:
Liver resection is treatment with curative intent for persons with early stage disease (BCLC-0/A).

For each surgery type, there should be a corresponding treatment record created in CORE-Treatment, with the correct treatment modality, date of treatment and organisation code recorded.

May be to one occurrence per record (0..1)

Liver Transplantation

Was the patient listed for transplantation?

Additional information:
This information is normally available in the patient record.

Rationale for inclusion:
Liver transplantation is suitable for persons with early stage disease (BCLC-0/A) and offers the greatest chance of cure of HCC. Not all persons who are listed for liver transplantation receive a transplant.

Cholangiocarcinoma is a contraindication for transplant, but patients may receive a transplant due to a misdiagnosis. It is important to record this.