A study to evaluate the usefulness of traction-assisted endoscopic submucosal dissection using a newly developed all-in-one device used to resect colorectal polyps: a Multicenter Randomized Controlled Trial

ABSTRACT: Interventions: Procedure/Surgery : 1) onestep knife conventional ESD (control) ? Insert the colonoscope with the transparent cap attached. ? After puncturing the submucosal layer immediately around the lesion with a puncture needle for submucosal solution injection, inject the saline-based submucosal solution. ? When the lesion is sufficiently raised, submucosal dissection is performed using a dual knife. ? Retrieve the resected specimen, fix it on a styrofoam fixing plate, and ask the pathology department for tissue analysis. (2) onestep knife + Traction ESD (intermediate group) ? Insert the colonoscope with the transparent cap attached. ? After puncturing the submucosal layer immediately around the lesion with a puncture needle for submucosal solution injection, inject the saline-based submucosal solution. ? When the lesion is sufficiently raised, submucosal dissection is performed using a dual knife. ? When performing ESD, make an incision around the lesion. After fixing the rubber band to the endoscope clip from the outside of the patient, insert it into the channel of the colonoscope and fix the clip at the end of the pre-incision lesion using the clip. Using the second clip, hold the rubber band secured to the pre-fastened first clip and secure the clip in a position that will provide adequate traction. ? Implement additional ESD. ? Retrieve the resected specimen and fix it on a styrofoam fixing plate, and then ask the pathology department for tissue analysis Primary outcome(s): procedure time; resection speed Primary Purpose : Treatment, Intervention Model : Parallel, Blinding/Masking : Single, Blinding Target : Subject, Allocation : RCT

DISEASE(S): Neoplasms

PROVIDER: 2514694 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR