Comparison of two new endoscopic techniques (endoscopic tri-modality imaging and chromoendoscopy-guided confocal laser endomicroscopy) with respect to their accuracy in colonoscopic surveillance in patients with ulcerative colitis. |
|- candidate number||8125|
|- NTR Number||NTR2362|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-jun-2010|
|- Secondary IDs||09/295 METC AMC|
|- Public Title||Comparison of two new endoscopic techniques (endoscopic tri-modality imaging and chromoendoscopy-guided confocal laser endomicroscopy) with respect to their accuracy in colonoscopic surveillance in patients with ulcerative colitis. |
|- Scientific Title||Endoscopic trimodality imaging (ETMI) vs. chromoendoscopy-guided confocal laser endomicroscopy (CCLE) as surveillance strategy for neoplasia in ulcerative colitis.|
|- hypothesis||Pilot research in experienced centers has suggested two surveillance strategies in patients with ulcerative colitis to be more efficient than standard endoscopy: (1) ETMI (endoscopic tri-modaility imaging), utilizing AFI and narrow band imaging (NBI); and (2) chromoendoscopy-guided confocal laser endomicroscopy (CCLE). These two new techniques have never been compared to one another. |
|- Healt Condition(s) or Problem(s) studied||Narrow band imaging, Ulcerative Colitis, Dysplasia, Chromoendoscopy, Surveillance, Confocal laser endomicroscopy (CLE), Autofluorescence|
|- Inclusion criteria||1. History of UC;|
2. Longstanding disease: extensive colitis >8 years; or left-sided colitis >15 years;
3. Age >18 years.
|- Exclusion criteria||1. Personal history of (partial) colectomy;|
2. Contraindications for the use of intravenous fluorescein (allergy, pregnancy or breastfeeding, severe cardiopulmonary disease or renal failure);
3. Currently known colonic neoplasia (e.g. referred patients or patients who refused treatment severe cardiopulmonary disease or renal failure);
4. Non-correctable coagulopathy that precludes taking biopsies (international normalized ratio >2; or platelet count <90*109);
5. No informed consent.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2010|
|- planned closingdate||1-mei-2012|
|- Target number of participants||235|
|- Interventions||Group CCLE: |
Each part of the colon (ascending, transverse, descending, recto sigmoid) will be sprayed with 0.1% methylene blue solution on withdrawal of the endoscope. Excess of dye will be removed and each colonic segment will be scrutinized for the presence of suspicious areas (discolored on CE), DALMs, ALMs, mucosal irregularities, unusual ulcers and strictures.
All suspicious lesions, defined suspicious when having a Kudo pit pattern III-V on CE, will be inspected by additional CLE and scored by the endoscopist as normal, regenerative, or neoplastic. Before starting the use of CLE, intravenous fluorescein (5mL; 10%) will be administered as contrast agent.
Lastly, four quadrant random biopsies will be taken every 10 cm of colon. Before taking these biopsies, all random areas will be inspected by CE for assessment of Kudo pit pattern. Mucosa with Kudo pit pattern III-V will subsequently be inspected by CLE (and scored as normal, regenerative, or neoplastic).
AFI will be used for scrutinizing the colon for the presence of suspicious areas (purple on AFI), DALMs, ALMs, mucosal irregularities, unusual ulcers and strictures. All lesions will be scored for AFI-color (green, ambiguous, purple) and subsequently inspected by NBI. During NBI, the Kudo pit pattern and vascular pattern intensity (VPI) will be scored.
Lastly, four quadrant random biopsies will be taken every 10cm of colon. Before taking these biopsies, all random areas will be inspected by AFI for assessment of AFI-color and by NBI for assessment of pit pattern and vascular pattern first.
|- Primary outcome||Diagnostic accuracy (defined as sensitivity, specificity and overall accuracy) of AFI plus NBI vs. CCLE for the differentiation of neoplastic and non-neoplastic mucosa, using final histopathology as reference standard diagnosis.|
|- Secondary outcome||1. Diagnostic accuracy of AFI plus NBI and CCLE to differentiate between dysplasia-associated dysplasia ('DALM') and sporadic adenomas ('ALMs'); DALMs are histologically proven neoplastic lesions with neoplasia in the adjacent ‘apparently normal’ mucosa, whereas ALMs do not demonstrate neoplasia in their adjacent mucosa;|
2. Proportion of patients with neoplasia, defined as the number of patients with at least one histologically confirmed neoplastic colonic lesion divided by the total number of included patients;
3. Mean number of neoplastic lesions per included patient, defined as the number of histologically confirmed neoplastic lesions divided by the total number of included patients;
4. The yield of random biopsies, defined by the number of patients with neoplasia detected by random biopsies only (confirmed by histopathology);
5. Location of neoplasia (either intraepithelial or invasive) detected during prospective follow-up colonoscopies (colonic segment, distance ab ano, location with respect to a resection scar if visible) or in the resection specimen after proctocolectomy.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Md PhD E. Dekker|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. E. Dekker|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC), Amsterdam|
|- Brief summary||Background:|
Surveillance colonoscopies in patients with ulcerative colitis leads to an early detection of neoplasia. Pilot research in experienced centers has suggested two surveillance strategies to be more efficient than standard endoscopy: (1) ETMI, utilizing AFI and narrow band imaging (NBI); and (2) chromoendoscopy-guided confocal laser endomicroscopy (CCLE). Once suspicious lesions are detected, it remains uncertain whether these can be considered as inflammatory, as DALMs (requiring proctocolectomy), or as ALMs (requiring endoscopical resection).
The aim of this randomized controlled study is to compare two surveillance strategies with respect to their accuracy in colonoscopic surveillance in IBD patients.
Randomized trial: consecutive patients with longstanding UC will be randomized to undergo surveillance colonoscopy with either ETMI or CCLE. (1) ETMI: AFI will be used for the detection of neoplastic lesions, and AFI plus NBI will be used for the differentiation of neoplastic from non-neoplastic mucosa. (2) CCLE: Likewise, CE will be used for detection and CCLE for differentiation of suspicious lesions. After examination with either ETMI or CCLE, targeted biopsies will be taken of detected lesions as well as 4 quadrant random biopsies each 10cm of colon.
|- Main changes (audit trail)|
|- RECORD||8-jun-2010 - 23-jun-2010|
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