The UK Intraductal Papillary Neoplasm of the Bile Duct Database
Research type
Research Database
IRAS ID
231375
Contact name
Alex Gordon-Weeks
Contact email
Research summary
The UK Intraductal Papillary Neoplasm of the Bile Duct Database
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
19/SW/0056
Date of REC Opinion
1 Jul 2019
REC opinion
Further Information Favourable Opinion
Data collection arrangements
The following data will be recorded:
Patient demographics (comorbidity, geographical location of residence, smoking, alcohol and family history, ASA grade, drug history, surgical history)pre-operative investigations: blood results including tumour markers liver function and haematology, cross sectional images (to be transferred to our hospital PACS system and select images from this system to be transferred to the research database), endoscopy written results and images, pre-operative biopsy or cytology results (including histological images) and mode of tissue acquisition
Details of pre-operative treatment regimen: chemotherapeutics, stenting of bile duct
Surgery details: date, type of resection, duration of surgery, blood loss, intra-operative complications, need for blood transfusion, mode of anaesthesia, type of analgesia
Post-operative recovery: length of stay, complications (Clavien-Dindo classification)
Histology: tumour subtype and growth pattern, presence of invasive disease, circumferential margin involvement and specimen quality, H&E images taken by the pathological department at the consenting centre
Post-operative therapy
Follow-up: recurrence, mode of recurrence diagnosis, long-term complication, mortality, Post-operative imaging findings (qs per pre-operative imaging, those images demonstrating recurrent disease will be reviewed at our center and select images stored within the database).
Data will be stored on a secure web-based application. This will include a patient portal with information about IPNB for a patient population.
Research programme
Intraductal papillary neoplasm of the bile duct (IPNB) is a rare tumour of the biliary tree. We wish to understand more about this disease process and so plan to collect data from patients diagnosed with the condition across the UK. Although IPNB is considered a benign tumour (i.e. it cannot spread to other organs), it is recognised that up to 40% of IPNB tumours removed at surgery have evidence of cancer within them. The surgery to remove IPNB is often complex with a risk of life-altering complications and IPNB can recur following surgery. For these reasons, selecting suitable patients for surgery (i.e. those that have developed cancer) and avoiding surgery in patients without cancer is crucial. Despite this, we have no means currently of differentiating between such patients. Collecting data from those patients diagnosed with IPNB will help us to identify factors suggestive of cancerous progression. The database will also help us to understand risk factors for the development of IPNB as well as the best way to follow up patients that do not need surgery as well as those that have already undergone surgery. The target population are therefore those patients with a new diagnosis of IPNB. From these patients we will collect data from their medical records in an attempt to understand the underlying causes of IPNB and we will also collect data about their follow-up in order to map patterns of IPNB recurrence.
Research database title
The UK Intraductal Papillary Neoplasm of the Bile Duct Database
Establishment organisation
Oxford University Hospitals NHS Foundation Trust
Establishment organisation address
Churchill Hospital
Old Road
Headington, Oxford
OX3 7LE