The Pre-operative Pathway in Pancreatic Head Malignancy-assessment of the Diagnostic Accuracy of Staging CT Scan

Completed

• Conditions: Cancer of Pancreas
• Interventions: Radiation: Computerised tomography (CT) scan

• Registration Number: NCT02296736
• Lead Sponsor: University Hospital Plymouth NHS Trust

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-11-18
• Study First Submitted QC: 2014-11-18
• Study First Posted: 2014-11-20
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-03
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 422

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pancreatic malignancy	Computerised tomography (CT) scan	All patients who have undergone surgery for presumed pancreatic malignancy in Derriford Hospital between Jan 2006 and Jan 14 and had a Computerised tomography (CT) scan.

Primary Outcome Measures

Name	Time	Method
Review pre-operative imaging to distinguish the organ of origin of pancreatic head tumours	8 years	Retrospective review of imaging of patients who have undergone surgery for presumed pancreatic malignancy

Secondary Outcome Measures

Name	Time	Method
Resectabilty of the pancreatic tumour	8 years	Retrospective review of imaging of patients who have undergone surgery for presumed pancreatic malignancy

Trial Locations

Locations (1)

Plymouth Hospitals NHS Trust; 🇬🇧 Plymouth, Devon, United Kingdom