A Randomized Prospective Study Evaluating Effectiveness of a Double Balloon Endoluminal Platform for Colorectal Endoscopic Submucosal Dissection
Endoscopic removal of colonic polyps and early cancers greatly reduces the need for surgical resection and possible temporary or permanent colostomy. However, ESD remains technically difficult, time-consuming, and labor-intensive procedure performed in a limited number of specialized high-volume centers. This study aim was to evaluate safety and time savings (cost-effectiveness) of colonic ESD assisted by DiLumen compared to traditional ESD performed without it.
Results supported the following:
DiLumen saved ESD dissection time and increased speed of dissection
DiLumen was cost-effective and saved money due to procedural time savings
More data and results are found in the body of the abstract.
(From ACG 2020 submission)
Learn More a randomized prospective study evaluating effectiveness of a double balloon and the Luminal platform for colorectal endoscopic mucosal dissection presenter dr sergei conceived the study was performed at Mercy Medical Center in Baltimore Maryland introduction. Endoscopic removal of colonic polyps and early cancers eliminates the need for surgical resection and possible temporary or permanent colostomy. Endoscopic sub Nichols of dissection allows and block removal of colonic lesions, reducing post procedural recurrence. However, endoscopic sub mucosal dissection remains technically difficult, time consuming and labor intensive procedure which is currently performed only in a limited number of specialized higher volume centers, double balloon and the Luminal platform is comprised of a flexible sheet preloaded over any Kelowna scope with two expendable balloons. One balloon called after balloon and it's firmly attached to the proximal end of the device near the scope ship. The second balloon called four balloons and it can be advanced and retracted by push rods, the balloons and sheet assists advancement of the Kelowna scope and the endoscopic future and device through the column providing multidirectional dynamic retraction and improving scope stability during colonial endoscopic mucosal resection and colonic endoscopic mucosal dissection. Aim of our study was to evaluate safety and time saving cost effectiveness of colonic endoscopic sub mucosal dissection assisted by a double balloon and aluminum platform compared to traditional colonic endoscopic sub mucosal dissection methods. It was a prospective randomized 1 to 1 study which was approved by Mercy Hospital center I. R. B. For removal of cecil colonic polyps over two centimeters in size patients with pd articulated colonic polyps were excluded from the study primary endpoint was endoscopic surgery because of dissection time in study, which was endoscopic sub because of this section, with the assistance of the double balloon and the Luminal platform and control, which was traditional endoscopic surgery because of dissection groups. Secondary endpoints included total procedure time at various time points and adverse events between the two groups. During initial procedure and three months follow up visit enrollment, Enrollment was set at 200 patients and interim analysis was scheduled after the 1st 140 patients were enrolled to assess if recruitment could be closed due to the primary endpoint being met. Results, Enrollment started in February 2019. An interim analysis was performed in February 2020. Study group consisted of 71 patients and control group consisted of 69 patients. Both groups were similar in lesion size patient's age and patients gender en bloc resection was achieved in 97.2% of the Device Group vs 85.5% of the control group. And this difference between groups was statistically significant. With p equals 0.016. Use of double balloon and the Luminal platform Increased speed of endoscopic sub mucosal dissection over control group by 49 and it was statistically significant difference. It also shortened Time of endoscopic sub mucosal dissection by 46.5%. Once again, the difference between study and control group was statistically significant and finally use of double balloon and aluminum platform decreased total procedure time by 36.5% and it was statistically significant difference uh comparing to the control group, there were no device related adverse events. In conclusion, the double balloon and Illumina platform markedly facilitated colonic endoscopic surgery because of dissection and improved the rate of en bloc resection. It also dramatically increased dissection speed and significantly reduced dissection and total procedure time. Thank you very much.