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EnteroCT With Enteroclysis Versus Enterography-MRI for the Diagnosis of Tumors of the Small Intestine: a Pilot Study (enteroMRI-TSI)

C

CHU de Reims

Status

Unknown

Conditions

Suspicion of Tumor of the Small Intestine

Treatments

Radiation: enteroCT with enteroclysis
Radiation: Enterography-MRI without enteroclysis

Study type

Interventional

Funder types

Other

Identifiers

NCT02872623
PO14065

Details and patient eligibility

About

Early diagnosis of tumors of the small intestine is a challenge for clinicians and for radiologists. The detection of tumors of the small intestine is a field in which the video capsule endoscopy has the lowest performance.

The entero-CT with enteroclysis is the imaging technique used primarily to explore patients with a strong suspicion of small intestine tumors. However the entero-CT with enteroclysis has disadvantages : it is irradiating, the nasojejunal tube implies a discomfort to the patient and it is a complicated examination in terms of logistics with necessity of specific equipment to insert the nasojejunal tube.

MRI has been proposed as an alternative imaging technique and satisfactory results have been reported with the MRI enteroclysis. However, this technique has several disadvantages related to nasojejunal tube insertion and the necessity of equipment compatible with the high magnetic fields. The enterography-MRI without enteroclysis, whose principle is to distend the small intestine by ingestion of large quantities of a liquid, has a major and undisputed role in the exploration of Crohn's disease of the small bowel. However, its capacity for distension of the small intestine for optimal tumor detection is questioned and its role in tumor detection is largely unknown.

Full description

Evaluate the diagnostic performances of enteroCT with enteroclysis and enterography-MRI without enteroclysis, for the diagnosis of tumor of the small intestine, among patients with suspicion of small intestine tumors.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patient clinically suspected of having a tumor of the small intestine
  • patient consenting to participate to the study
  • patient enrolled in the national healthcare insurance program
  • patient older than 18 years

Exclusion criteria

  • patient with inflammatory bowel disease
  • patient with contraindication for MRI

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

experimental group
Experimental group
Description:
patients clinically suspected of having a tumor of the small intestine
Treatment:
Radiation: Enterography-MRI without enteroclysis
Radiation: enteroCT with enteroclysis

Trial contacts and locations

1

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Central trial contact

Alban COLOSIO

Data sourced from clinicaltrials.gov

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