Bloodflow measurements in stenotic inflammatory bowel disease.

• Register: EUCTR
• Last refreshed on: 10 August 2021
• Main ID: EUCTR2011-005846-36-DK
• Date of registration: 31/07/2012
• Prospective Registration: Yes
• Primary sponsor: Gastroenterology MIDT
• Public title: Bloodflow measurements in stenotic inflammatory bowel disease.
• Scientific title: Safe evaluation of obstructive crohns disease using bloodflow Time-intensity curves and Elastography correlated to Neutrocytes and collagen counts and biomechanical properties Obtained in Stenotic Intestine after Surgery (STENOSIS) - STENOSIS
• Date of first enrolment: 31/07/2012
• Target sample size: 25
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005846-36
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no; Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Denmark

Contacts

• Name: Henning Glerup
• Affiliation: Regionshospitalet Silkeborg

• Name: Henning Glerup
• Affiliation: Regionshospitalet Silkeborg

Key inclusion & exclusion criteria

Inclusion criteria:
Crohns Disease
Referred to elective surgery for intestinal stenosis
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion criteria:
Female subjects who are pregnant ore breastfeeding.
Contraindications for MRI with Dotarem
Contraindications for Sonovue
Discontinued surgery
Stenosis not detectable by MRI and US.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Crohns Disease undergoing elective surgery for intestinal stenosis.
MedDRA version: 14.1 Level: PT Classification code 10058829 Term: Elective surgery System Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 14.1 Level: PT Classification code 10059696 Term: Scan with contrast System Organ Class: 10022891 - Investigations
MedDRA version: 14.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1 Level: LLT Classification code 10028049 Term: MRI System Organ Class: 10022891 - Investigations
MedDRA version: 14.1 Level: PT Classification code 10045434 Term: Ultrasound scan System Organ Class: 10022891 - Investigations
MedDRA version: 14.1 Level: PT Classification code 10022699 Term: Intestinal stenosis System Organ Class: 10017947 - Gastrointestinal disorders

Intervention(s)

Trade Name: SonoVue
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: sulphur hexafluoride
CAS Number: 2551-62-4
Other descriptive name: SULFUR HEXAFLUORIDE
Concentration unit: µl/ml microlitre(s)/millilitre
Concentration type: equal
Concentration number: 8-

Primary Outcome(s)

Main Objective: Main objective: To evaluate if intestinal wall perfusion, elasticity or peristaltics in patients with CD assessed with the modalities a) dynamic MRI, b) Contrast Enhanced UltraSound (CEUS) or c) Elastography UltraSound (EUS) are correlated to the degree of active or chronic disease and stiffness of tissue.

Secondary Objective: Secondary objective: To evaluate which parameters obtained from intestinal wall perfusion, elasticity or peristaltics in patients with CD assessed with the modalities a) dynamic MRI, b) Contrast Enhanced UltraSound (CEUS) or c) Elastography UltraSound (EUS), as well as postsurgery degree of active or chronic disease and stiffness of tissue that correlates to bloodsamples, fecalsamples and questionnaire results.

Primary end point(s): Preoperative evaluation with MRI, CEUS and EUS will be compared to postoperative specimen degree of
1) Active disease (assessed by histomorphometry and histoligyscore),
2) Chronic disease (assessed by histomorphometry, histologyscore and hydroxyprolin)
3) distensibility (assesses by impedance planimetry).

Timepoint(s) of evaluation of this end point: At time of surgery

Secondary Outcome(s)

Secondary end point(s): C-reactive protein (blood sample), Calprotectin (stool sample), Crohns Disease Activity Index and Harvey-Bradshaw Index (questionnaire).

Timepoint(s) of evaluation of this end point: At time of surgery and at time of imaging - no more than 4 weeks prior to surgery.

Secondary ID(s)

HGKKRWPHD

Source(s) of Monetary Support

Abbott Denmark

Ethics review

Status: Approved
Approval date: 20/07/2012
Contact: