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van CCT (UK)

van CCT (UK)

Narrow band imaging compared with conventional enteroscopy for detection of inflammation in small bowel in patients with Crohn’s disease.

- candidate number6556
- NTR NumberNTR2044
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-okt-2009
- Secondary IDs2009-234 MEC ErasmusMC
- Public TitleNarrow band imaging compared with conventional enteroscopy for detection of inflammation in small bowel in patients with Crohn’s disease.
- Scientific TitleNarrow band imaging compared with conventional enteroscopy for detection of inflammation in small bowel in patients with Crohn’s disease.
- ACRONYMNIBI in small bowel IBD
- hypothesisPrimary endpoint: Comparison of NBI enteroscopy with WLE in detection and grading of CD inflammation in small bowel.disease activity.
- Healt Condition(s) or Problem(s) studiedIron deficiency , Anemia, Inflammatory bowel disease
- Inclusion criteria1. Patients known with CD and suspted small bowel disease activity;
2. Patients with iron deficiency anemia (control subjects);
3. Age 18 years or older.
- Exclusion criteria1. Under 18 years of age;
2. Medical and psychological contraindications for balloon assisted enteroscopy;
3. Patients unable or not willing to give informed consent.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 10-jan-2009
- planned closingdate10-jan-2010
- Target number of participants0
- InterventionsAll procedures are performed by endoscopists experienced with the balloon assisted enteroscopy technique. Sedation is given according to current standards. Oral enteroscopy is always performed first, supplemented by enteroscopy via the anal route, if indicated.
Enteroscopy is performed using the single balloon endoscope system with a prototype of NBI system (SIF-Q180, Olympus Optical Co., Ltd., Tokyo, Japan). The endoscope consists of a 200-cm long video endoscope with an outer diameter of 9.2 mm and a flexible overtube with a length of 140 cm and an outer diameter of 13.2 mm. One single balloon is attached to the tip of the overtube. The insertion process consists of introduction of the tip of the enteroscope, following by positioning the overtube to the tip of the enteroscope. The balloon on the tip of the overtube is inflated, the tip of the enteroscope is angulated, and both are pulled back. Repeating this step, in theory, the whole small bowel can be visualized6 Narrow band imagin (NBI) technique The filter of light source for NBI was composed of two bands: a light with a wavelength for the blue band and the other for the green band. Using the single balloon enteroscopy system, both the conventional white light and NBI view can be switched alternatively by pushing a preset button on the head of the enteroscope.
- Primary outcomePrimary endpoint: Comparison of NBI enteroscopy with white light in detection and grading of Crohn's disease inflammation in small bowel.
- Secondary outcomeSecondary endpoints:
1. Correlation of endoscopic findings with clinical findings;
2. Correlation of endoscopic findings with conventional histopathology;
3. Correlation of endoscopic findings with immunohistochemical analysis of immunocompetent cells and mRNA levels of proinflammatory cytokines.
- TimepointsEvery 3 months in one year.
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator Erasmus Medical Center, Department of Gastroenterology and Hepatology
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, Department of Gastroenterology and Hepatology
- PublicationsN/A
- Brief summaryCrohn’s disease (CD) is a chronic inflammatory disease of the entire gastrointestinal tract. CD is mainly localised in the ileocecal region (38%), ileum (27%) and colon (19%). In up to 20% of CD patients, disease activity is located in the upper gastrointestinal tract , which in great part is not accessible for standard diagnostic techniques (i.e. gastroduodeno- and ileocolonoscopy). Small bowel involvement of CD is known as an independent risk factor for complicated disease. CD patients with small bowel activity more often need step-up medical treatment and surgical interventions. Timely detection of small bowel activity of CD might lead to adjustment of therapy to prevent complications of the disease. Since the introduction of balloon assisted enteroscopy (BAE) and wireless capsule endoscopy (WCE), endoscopic visualization of the entire small bowel has become possible and is therefore of great interest for CD patients. BAE has proven its additional value in known CD patients with suspected small bowel activity. It was shown that in up to 70% of patients, small bowel disease activity was found. In 40% of these patients, this disease activity was not accessible for conventional endoscopy.
Nevertheless, in approximately one third of CD patients with complaints suspected for small bowel disease activity, no evident signs of inflammation are found. We hypothesize that in a subset of these patients minor mucosal inflammation is present, which is not visualized with the current standard (white light) endoscopic techniques. Leaving this minor mucosal inflammation undetected and therefore untreated, might result in relapse and complicated CD. These patients could profit from early detection and timely adjustment of (medical) therapy. To visualize this inflammation, improved techniques for a better assessment of the grade of inflammation than the conventional white light endoscopy (WLE) used by enteroscopy are necessary. Narrow band imaging (NBI) endoscopy is a unique system by the application of narrow band filers for the light source [13, 14]. This results in different images at distinct levels of the mucosa and increases the contrast between the epithelial surface and the subjacent vascular pattern. NBI visualizes the disorganization of the pit pattern and vascular pattern of the gastrointestinal mucosa in inflammatory and neoplastic (premalignant and malignant) lesions. NBI is used and proven accurate for the screening of gastrointestinal and oropharyngeal neoplasms. In ulcerative colitis NBI can determine the grade of inflammation in patients with ulcerative colitis.
- Main changes (audit trail)
- RECORD6-okt-2009 - 29-okt-2009

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