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CT Colonography as the Initial Diagnostic Imaging Tool for Patients With Suspected Colorectal Cancer (CTCS)

G

Guy's and St Thomas' NHS Foundation Trust

Status

Unknown

Conditions

Colorectal Cancer

Treatments

Procedure: CTC
Procedure: Optical colonoscopy

Study type

Observational

Funder types

Other

Identifiers

NCT02820389
Colon CT study

Details and patient eligibility

About

This study aims to evaluate whether the use of Computed Tomography Colonography (CTC) for patients with low to intermediate risk of suspected colorectal cancer decreases overall NHS costs and waiting times whilst increasing patient satisfaction compared to clinical practice with utilisation of Optical Colonoscopy.

Full description

Given the recent change in the NICE guidance for the cancer pathway referral for patients with suspected colorectal cancer (See NG12), there will be an increase in demand for optical colonoscopy. Optical colonoscopy is technically difficult, resource intensive and associated with complications; therefore the increased use of CT Colonography (CTC) should be considered as an alternative. The diagnostic efficacy of CTC, in comparison to optical colonoscopy, is well established and has been shown to be accurate for identifying malignancies and medium to large polyps (≥6mm) with a greater level of patient acceptability.

The use of CTC as the first diagnostic imaging tool would identify those patients who would benefit from further investigation (colonoscopy or flexible sigmoidoscopy) to occur on the same day, as well as ruling out those who do not require further testing. This would then ensure that colonoscopy capacity can be prioritised appropriately to support the increase in demand due to the NICE guidance changes.

Enrollment

246 estimated patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Every adult patient over 40 years old, presenting with constipation or alternating change in bowel habits, with a differential diagnosis of suspected colorectal cancer.

Exclusion criteria

  • Patients presenting with anaemia;
  • Patients presenting with diarrhoea only for more than 6 weeks;
  • Patients presenting with rectal bleeding;
  • Patients who have undergone a previous whole-colon examination in the past 6 months;
  • Patients who have been referred for a whole-colon examination to follow up already diagnosed colorectal cancer;
  • Patients lacking capacity to give consent or participate in the study;
  • Patients already taking part in any clinical trial of an investigational medicinal product (CTIMP);
  • Prisoners
  • Patients who are not fluent in English.

Trial design

246 participants in 2 patient groups

Optical colonoscopy
Description:
Patients with suspected colorectal cancer will undergo optical colonoscopy as the initial imaging modality.
Treatment:
Procedure: Optical colonoscopy
CT Colonography
Description:
Patients with suspected colorectal cancer will undergo Computed Tomography Colonography (CTC) as the initial imaging modality. Subsequent imaging might be required based on the findings from the CTC scan.
Treatment:
Procedure: CTC

Trial contacts and locations

1

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Central trial contact

Bharti Malhotra, MSc; Tiago Rua, MSc

Data sourced from clinicaltrials.gov

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