NCT02296736

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
422

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

September 4, 2019

Status Verified

September 1, 2019

Enrollment Period

2.9 years

First QC Date

November 18, 2014

Last Update Submit

September 3, 2019

Conditions

Keywords

computerised tomography (CT) scandiagnostic accuracyPancreatic head malignancy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Resectabilty of the pancreatic tumour

    8 years

Study Arms (1)

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

Interventions

Retrospective review of CT scans

Pancreatic malignancy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Retrospective review of imaging of all patients who have undergone surgery for presumed pancreatic malignancy in Derriford Hospital.

You may qualify if:

  • All patients who have undergone surgery for presumed pancreatic malignancy in Derriford Hospital between Jan 2006 and Jan 14 will be included.

You may not qualify if:

  • Not applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Plymouth Hospitals NHS Trust

Plymouth, Devon, PL6 8BX, United Kingdom

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • David Stell, MBBS, PhD

    University Hospital Plymouth NHS Trust

    STUDY DIRECTOR
  • Bassem Amr, MBBS

    University Hospital Plymouth NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2014

First Posted

November 20, 2014

Study Start

October 1, 2014

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

September 4, 2019

Record last verified: 2019-09

Locations