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

Not Applicable

• Conditions: Suspicion of Tumor of the Small Intestine
• Interventions: Radiation: Enterography-MRI without enteroclysis; Radiation: enteroCT with enteroclysis

• Registration Number: NCT02872623
• Lead Sponsor: CHU de Reims

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2015-03
• Status Verified: 2016-08
• Study First Submitted: 2016-08-16
• Study First Submitted QC: 2016-08-16
• Study First Posted: 2016-08-19
• Last Update Submitted: 2016-08-29
• Last Update Posted: 2016-08-30
• Primary Completion: 2018-03
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experimental group	enteroCT with enteroclysis	patients clinically suspected of having a tumor of the small intestine
experimental group	Enterography-MRI without enteroclysis	patients clinically suspected of having a tumor of the small intestine

Primary Outcome Measures

Name	Time	Method
Presence of a tumor of the small intestine	12 months	Presence of a tumor of the small intestine diagnosed using pathological results or using clinical evaluation at 12 months (if no biopsy is performed).

Trial Locations

Locations (1)

Chu de Reims; 🇫🇷 Reims, France