RESUMEN
BACKGROUNDS & AIMS: Endoscopic submucosal dissection (ESD) can be challenging/time-consuming. A Double Balloon Interventional Platform (DBIP) was designed to assist with navigation, stabilization, traction and device delivery during complex colorectal polypectomy. STUDY AIM: to compare traditional (T-ESD) to DBIP-assisted ESD (DBIP-ESD) in a prospective, randomized trial. METHODS: Patients with colorectal polyps ≥ 2 cm were randomly assigned (1:1) to DBIP-ESD or T-ESD. Primary study endpoint: mean total procedure time difference between groups. Secondary endpoints: intra-procedural time-points, en bloc resection rate, procedure cost, adverse events, and 3-month assessment. A sample size of 200 subjects for ≥ 80% power was calculated. Interim analysis for early study termination was planned at 70% enrolment if primary endpoint was met (p ≤ 0.05). RESULTS: 147 patients were enrolled between February 2019-February 2020. Seven patients dropped out. Interim analysis was performed on 140 patients (71 DBIP-ESD, 69 T-ESD). Demographics, co-morbidities, lesion size/location/classification were similar between groups. Mean procedure time decreased with DBIP (88.6±42.7 min) vs. T-ESD (139.5±83.2 min), [51 minutes, 36.5%, p<0.001], with procedural savings of $760.16 (14%) per patient after DBIP cost. DBIP increased dissection speed by 49.0% (15.1±8.0 vs 7.7±6.6 cm2/hour, p< 0.001). En bloc resection was superior with DBIP (97.2% vs 87.0%, p=0.030). Mean navigation time with DBIP for sutured defect closure decreased by 7.7 minutes (p<0.001). There were no adverse events in the DBIP group. CONCLUSIONS: DBIP decreased total procedure time, improved en bloc resection rate, facilitated sutured defect closure, making DBIP a promising and cost-effective tool to improve colorectal ESD adoption.
RESUMEN
The aim of this research study was to evaluate the effectiveness of lidocaine versus lidocaine with sodium bicarbonate in reducing anxiety and pain, using visual analog scales, in subjects receiving local anesthetic during liver biopsies. The project included 199 subjects presenting for percutaneous liver biopsy using local anesthesia. Subjects were randomized into 2 groups: the control group, which received lidocaine alone, and the experimental group, which received lidocaine buffered with sodium bicarbonate. Immediately after they received the lidocaine injection, both groups were asked to rate their preprocedure anxiety and pain using a 0-10 visual analog scale. Mean postprocedure pain was statistically significantly different between the two arms with the intervention group reporting less pain (1.65 vs. 2.27, p = .037). Change in pain scores between the two groups were also statistically significantly different with the intervention group reporting a mean change in pain score of 0.93 compared to 1.63 in the control group (p = .021). However, no differences were found for reported anxiety. This study has shown that using sodium bicarbonate with lidocaine significantly decreased pain sensation at the injection site when used for deep visceral anesthesia during percutaneous liver biopsy.