Stopped: Not funded
The goal of this clinical research study is to learn whether two advanced imaging tools, called Texture and Color Enhancement Imaging (TXI) and Red Dichromatic Imaging (RDI), can make the removal of large colon polyps safer, faster, and more effective. These tools are built into the Olympus EVIS X1 endoscopy system and are already approved for use in standard colonoscopy. TXI helps enhance the surface detail and color contrast of the colon lining, while RDI improves visibility of deeper blood vessels. The study is testing how these imaging modes can be used in a structured way to guide endoscopic mucosal resection (EMR), a non-surgical technique that removes large, precancerous polyps from the colon. Large or complex colon polyps can sometimes turn into cancer if they are not completely removed. EMR is an important alternative to surgery because it allows these growths to be removed through the colonoscope, reducing recovery time and risk. However, two problems still occur in some cases: incomplete removal of the polyp, which can lead to recurrence, and delayed bleeding after the procedure. STRIkER aims to see whether using TXI and RDI in a structured workflow can lower these risks and improve the overall quality of the procedure. This is a prospective, single-center study taking place at the Medical College of Wisconsin. It includes two parts. The first is a randomized controlled trial comparing EMR performed with TXI versus standard high-definition white light. The goal is to determine whether TXI shortens the time needed to remove a polyp and improves visualization during resection. The second part is an observational study that uses RDI after EMR to examine the resection area for blood vessels or other features that might predict delayed bleeding. In this arm, researchers will evaluate whether certain visual features seen with RDI are linked to a higher risk of bleeding after the procedure. Adults aged 18 years or older who are undergoing colonoscopy for removal of one or more large (20 millimeter or larger), nonpedunculated colon polyps may take part. Participants will receive standard clinical care, including bowel preparation, colonoscopy, and post-procedure monitoring. During the colonoscopy, the endoscopist will use either TXI or standard white light during the polyp removal phase, depending on random assignment. After removal, RDI may be used to inspect the resection area. Photos and short video clips may be collected for research review, but all images will be de-identified and stored securely. No experimental drugs or devices are used in this study, and there are no additional procedures beyond the standard colonoscopy and EMR. Participants will have follow-up through the existing clinical workflow. A routine phone call will occur within a few days after the procedure to check for any early side effects or bleeding. For those in the RDI portion of the study, medical records will be reviewed about 30 days after the procedure to look for any delayed bleeding or unplanned visits. Participants in the TXI portion will have their standard follow-up colonoscopy, usually around six months after the initial procedure, to check whether any tissue has grown back at the site. The information from this study will help researchers understand how image-enhanced endoscopy can be applied in real-world settings to make complex colon polyp removal safer and more reliable. If TXI and RDI improve visualization and reduce complications without adding risk or cost, this approach could be easily adopted by hospitals already using Olympus equipment. The long-term goal is to develop larger, multicenter studies and eventually establish standardized, image-guided protocols that help prevent colorectal cancer more effectively through high-quality endoscopic resection.
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Total Resection Time (TXI vs. White Light)
Timeframe: During EMR procedure (Day 0).