Bloodflow measurements in stenotic inflammatory bowel disease.

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005846-36-DK

Enrollment

Registered

2012-07-31

Start date

2012-07-31

Completion date

Unknown

Last updated

2021-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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 vers

Interventions

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 uni

Eligibility

Sex/Gender

All

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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.	—

Countries

Denmark

Contacts

Public ContactHenning Glerup

Regionshospitalet Silkeborg

runwil@rm.dk004578417575

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026