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

September 3, 2019 updated by: University Hospital Plymouth NHS Trust
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

422

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Devon
      • Plymouth, Devon, United Kingdom, PL6 8BX
        • Plymouth Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Radiation: Computerised tomography (CT) scan
Retrospective review of CT scans

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Review pre-operative imaging to distinguish the organ of origin of pancreatic head tumours
Time Frame: 8 years
Retrospective review of imaging of patients who have undergone surgery for presumed pancreatic malignancy
8 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resectabilty of the pancreatic tumour
Time Frame: 8 years
Retrospective review of imaging of patients who have undergone surgery for presumed pancreatic malignancy
8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Plymouth NHS Trust

Investigators

  • Study Director: David Stell, MBBS, PhD, University Hospital Plymouth NHS Trust
  • Principal Investigator: Bassem Amr, MBBS, University Hospital Plymouth NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

November 18, 2014

First Submitted That Met QC Criteria

November 18, 2014

First Posted (Estimate)

November 20, 2014

Study Record Updates

Last Update Posted (Actual)

September 4, 2019

Last Update Submitted That Met QC Criteria

September 3, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14/P/090
  • 14/SC/1391 PR (Other Identifier: National Research Ethics Service (NRES))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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