Interest of Saline MR Peritoneography for Pre-operative Assessment of Rectal Cancer

Rectal Adenocarcinoma Clinical Trial

Official title:

Interest of Saline MR Peritoneography for Pre-operative Assessment of Rectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01497457
• Other study ID #: B403201112604
• Status: Completed
• Phase: N/A
• First received: December 14, 2011
• Last updated: May 19, 2015
• Start date: December 2011
• Est. completion date: September 2013

Study information

• Verified date: May 2015
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

MR saline peritoneography could be useful to demonstrate the peritoneal outline of the pouch of Douglas. The investigators think that the localization of the rectal tumor in function of this anatomic mark could be decisive for pre-operative assessment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Rectal adenocarcinoma

Exclusion Criteria:

• Metastatic disease

• under 18y patient

• woman of childbearing age

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adenocarcinoma
• Rectal Adenocarcinoma
• Rectal Neoplasms

Intervention

Procedure:
• MR saline peritoneography
Ultrasound-guided Intraperitoneal injection of 250cc of steril saline solution with a 22G needle, followed by rectal MR imaging

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires St Luc - Université Catholique de Louvain	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of the distance between a rectal tumor and the pouch of Douglas	Feasability of the determination of the distance between a rectal tumor and the pouch of Douglas by MR saline peritoneography: Visualisation of the Douglas; Visualisation of the Tumor; Determination of the distance between the tumor and the pouch of Douglas	Two years	No