Hospital del Mar
Barcelona, 08003, Spain
NCT Number: NCT02448693
This study is designed to evaluate the diagnostic accuracy of Narrow Band Imaging (NBI) compared with High Definition White Light colonoscopy (WLE) for detection of residual neoplasia in subjects with piecemeal polypectomy scars.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Barcelona, 08003, Spain
Resection of large sessile polyps in the colon (usually more than 2 cm) or those nonpolypoid neoplastic lesions (also called laterally spreading tumors or LST), confers technical difficulty and often are forced to remove into fragmented resection or endoscopic piecemeal mucosal resection. This has been associated with a recurrence of 25%. For this reason, clinical guidelines recommend endoscopic follow-up at 2 to 6 months after piecemeal resection of colorectal polyps to check for residual neoplasia.
Narrow-Band Imaging (NBI, Olympus) improves visibility and identification of the surface and vascular structures of colon polyps. In contrast to conventional chromoendoscopy, it is easily activated by pressing a button on the endoscope.
Virtual or conventional chromoendoscopy are applied during resection of polyps defining the border of the lesion. However, there are few studies using Narrow Band Imaging and do not allow to know whether the use of this technique could improve the detection of residual tumor after fragmented polypectomy and avoid complications, time and costs of biopsy and histological analysis.
In this context, the European Society of Gastrointestinal Endoscopy (ESGE) has recently published the first Guideline of Advanced Endoscopic Imaging for the Detection and Differentiation of Colorectal Neoplasia and recommends conventional or virtual chromoendoscopy in patients with piecemeal polypectomy scar (strong recommendation, low quality evidence).
The investigators will perform a randomised, controlled trial of tandem colonoscopy using NBI and WLE. The main goal is to compare the rate of detected neoplasia between both techniques and evaluate the diagnostic accuracy of NBI and WLE to histology as the gold standard.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Evaluation of the polypectomy scar with High Definition White Light Endoscopy (WLE)
Other names: High Definition colonoscopy with White Light Endoscopy (WLE)
Evaluation of the polypectomy scar with Narrow Band Imaging (NBI, Evis Exera III, Olympus).
Other names: Narrow Band Imaging
Time frame: less than 1 year after the basal colonoscopy
Efficacy of NBI in detecting residual neoplasia compared with WLE
Time frame: less than 1 year after the basal colonoscopy
Accuracy in detecting neoplastic tissue endoscopically compared with histopathology (gold standard)
Time frame: less than 1 year after the basal colonoscopy
Compare the number of missed lesions from the basal colonoscopy
Parc de Salut Mar
Other
Randomised Tandem Colonoscopy of Narrow Band Imaging (NBI) and White Light Endoscopy in Patients With Endoscopic Piecemeal Mucosal Resection
Acronym: CROMOPIE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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