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Completed

NCT Number: NCT02296736

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

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.

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Key information

Conditions

Cancer of Pancreas Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Plymouth Hospitals NHS Trust

Plymouth, Devon, PL6 8BX, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computerised tomography (CT) scan

Radiation

Retrospective review of CT scans

Primary outcomes

  1. 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

Secondary outcomes

  1. Resectabilty of the pancreatic tumour

    Time frame: 8 years

    Retrospective review of imaging of patients who have undergone surgery for presumed pancreatic malignancy

Sponsors and collaborators

Lead sponsor

University Hospital Plymouth NHS Trust

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 20, 2014
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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