Small bowel surveillance in patients with Peutz-Jeghers syndrome: comparing MR enteroclysis with double balloon enteroscopy.

Completed

• Conditions: Hamartomatous intestinal polyposis; polyps-and-spots syndrome; 10018018; 10017934

• Registration Number: NL-OMON38353
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Patients >= 18 years;
Patients who are willing and able to give informed consent.

Exclusion Criteria

Inability to provide informed consent;
General contraindications to MR imaging (pacemaker or cardioversion device, claustrophobia, certain implanted metallic devices);
Patients with known contrast allergy;
Abdominal surgery in the 6 weeks prior to inclusion;
Pregnancy.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Diagnostic yield of DBE and MRE, including number, location and size of polyps<br /><br>in the small bowel of PJS patients. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Quality of life and patients' appreciation of MRE and DBE;<br /><br>- The need for DBE if MRE will be the primary surveillance method (for polyps >=<br /><br>15 mm);<br /><br>- Detection of significant extra-intestinal lesions with MRI;<br /><br>- Total costs of both procedures;<br /><br>- Complication rate of both procedures. </p><br>