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

Cancer of Pancreas Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02296736
• Other study ID #: 14/P/090
• Secondary ID: 14/SC/1391 PR
• Status: Completed
• Start date: October 2014
• Est. completion date: September 2017

Study information

• Verified date: September 2019
• Source: University Hospital Plymouth NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 422
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of Pancreas
• Neoplasms
• Pancreatic Neoplasms

Intervention

Radiation:
• Computerised tomography (CT) scan
Retrospective review of CT scans

Locations

Country	Name	City	State
United Kingdom	Plymouth Hospitals NHS Trust	Plymouth	Devon

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Plymouth NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Review pre-operative imaging to distinguish the organ of origin of pancreatic head tumours	Retrospective review of imaging of patients who have undergone surgery for presumed pancreatic malignancy	8 years
Secondary	Resectabilty of the pancreatic tumour	Retrospective review of imaging of patients who have undergone surgery for presumed pancreatic malignancy	8 years