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

NCT ID: NCT02296736

Last Updated: 2019-09-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 422 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2017-09-30

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.

Conditions

Cancer of Pancreas

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Pancreatic malignancy

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.

Computerised tomography (CT) scan

Intervention Type: RADIATION

Retrospective review of CT scans

Interventions

Computerised tomography (CT) scan

Retrospective review of CT scans

Intervention Type: RADIATION

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Plymouth NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Stell, MBBS, PhD

Role: STUDY_DIRECTOR

University Hospital Plymouth NHS Trust

Bassem Amr, MBBS

Role: PRINCIPAL_INVESTIGATOR

University Hospital Plymouth NHS Trust

Locations

Plymouth Hospitals NHS Trust

Plymouth, Devon, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 28270136 (View on PubMed)

Other Identifiers

14/SC/1391 PR

Identifier Type: OTHER

Identifier Source: secondary_id

14/P/090

Identifier Type: -

Identifier Source: org_study_id