Clinical trial NCT02296736: The Pre-operative Pathway in Pancreatic Head Malignancy-assessment of the Diagnostic Accuracy of Staging CT Scan
Official title: The Pre-operative Pathway in Pancreatic Head Malignancy-assessment of the Diagnostic Accuracy of Staging CT Scan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer of Pancreas
Keywords: computerised tomography (CT) scan
diagnostic accuracy
Pancreatic head malignancy
Lead sponsor: University Hospital Plymouth NHS Trust
Sponsor class: OTHER
First posted: 2014-11-20
Enrollment: 422
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospective review of imaging of all patients who have undergone surgery for presumed pancreatic malignancy in Derriford Hospital.

Brief summary: Our aim is to assess the ability of scans to distinguish the organ of origin of pancreatic head malignant tumours and to predict the resectability based on the preoperative imaging. To achieve this, a retrospective review of the preoperative CT scans will be conducted for all patients with pancreatic head malignancy treated at the Peninsula Hepato-Pancreatico-Biliary (HPB) cancer unit between January 2006 till January 2014.

Detailed description: Pancreatic cancer arises from the glandular part of the pancreas and is the fifth most common cause for cancer related death in the UK. It. Ampullary carcinoma arises from the epithelium of the ampulla of Vater into which the common bile duct and pancreatic duct drain. Cholangiocarcinoma arises from the bile duct epithelium, and may occur within the intra-pancreatic portion of the distal common bile duct mimicking a pancreatic malignancy. Cancers arising from these origins often cause obstructive jaundice and are hard to distinguish. Surgery is indicated for the treatment of these types of malignant tumours, and the definitive final diagnosis is usually not known until the specimen is examined. This situation does not allow specific treatment to be given pre-operatively, so-called 'neo-adjuvant therapy'. The rationale for this approach is that in a proportion of patients the tumour will be made smaller by this treatment, which may facilitate surgical resection.

Eligibility criteria: Inclusion Criteria:

* All patients who have undergone surgery for presumed pancreatic malignancy in Derriford Hospital between Jan 2006 and Jan 14 will be included.

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: Review pre-operative imaging to distinguish the organ of origin of pancreatic head tumours
timeFrame: 8 years
Secondary outcomes:
measure: Resectabilty of the pancreatic tumour
timeFrame: 8 years
Other outcomes:
Locations:
city: Plymouth
country: United Kingdom
facility: Plymouth Hospitals NHS Trust
state: Devon
Study officials:
affiliation: University Hospital Plymouth NHS Trust
name: David Stell, MBBS, PhD
role: STUDY_DIRECTOR
affiliation: University Hospital Plymouth NHS Trust
name: Bassem Amr, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amr B, Shahtahmassebi G, Aroori S, Bowles MJ, Briggs CD, Stell DA. Variation in survival after surgery for peri-ampullary cancer in a regional cancer network. BMC Surg. 2017 Mar 7;17(1):23. doi: 10.1186/s12893-017-0220-3.