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

NCT ID: NCT02872623

Last Updated: 2016-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2018-09-30

Brief Summary

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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

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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.

Conditions

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Suspicion of Tumor of the Small Intestine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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experimental group

patients clinically suspected of having a tumor of the small intestine

Group Type EXPERIMENTAL

Enterography-MRI without enteroclysis

Intervention Type RADIATION

enteroCT with enteroclysis

Intervention Type RADIATION

Interventions

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Enterography-MRI without enteroclysis

Intervention Type RADIATION

enteroCT with enteroclysis

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CHU de Reims

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu de Reims

Reims, France, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Alban COLOSIO

Role: CONTACT

Facility Contacts

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Alban COLOSIO

Role: primary

Other Identifiers

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PO14065

Identifier Type: -

Identifier Source: org_study_id

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