Browsing by Author "Broadley, Heather M."

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    A comparison of 2 distal attachment mucosal exposure devices: a noninferiority randomized controlled trial
    (Elsevier, 2019) Rex, Douglas K.; Sagi, Sashidhar V.; Kessler, William R.; Rogers, Nicholas A.; Fischer, Monika; Bohm, Matthew E.; Dewitt, John M.; Lahr, Rachel E.; Searight, Meghan P.; Sullivan, Andrew W.; McWhinney, Connor D.; Garcia, Jonathan R.; Broadley, Heather M.; Vemulapalli, Krishna C.; Medicine, School of Medicine
    Background and Aims Endocuff and Endocuff Vision are effective mucosal exposure devices for improving polyp detection during colonoscopy. AmplifEYE is a knock-off device that appears similar to the Endocuff devices but has received minimal clinical testing. Methods We performed a randomized controlled clinical trial using a noninferiority design to compare Endocuff Vision with AmplifEYE. Results The primary endpoint of adenomas per colonoscopy was similar in AmplifEYE at 1.63 (2.83) versus 1.51 (2.29) with Endocuff Vision; p=0.535. The 95% lower confidence limit was 0.88 for ratio of means, establishing noninferiority of AmplifEYE (p=0.008). There was no difference between the arms in mean insertion time, and mean inspection time (withdrawal time minus polypectomy time and time for washing and suctioning) was shorter with AmplifEYE (6.8 minutes vs 6.9 minutes, p=0.042). Conclusions AmplifEYE is noninferior to Endocuff Vision for adenoma detection. The decision of which device to use can be based on cost. Additional comparisons of AmplifEYE to Endocuff by other investigators are warranted.
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    Endoscopic control of polyp burden and expansion of surveillance intervals in serrated polyposis syndrome
    (Elsevier, 2018) MacPhail, Margaret E.; Thygesen, Scott B.; Patel, Nedhi; Broadley, Heather M.; Rex, Douglas K.; Medicine, School of Medicine
    Introduction Serrated polyposis syndrome (SPS) increases colorectal cancer (CRC) risk. We describe the numbers of colonoscopies and polypectomies performed to achieve and maintain low polyp burdens, and the feasibility of expanding surveillance intervals in patients who achieve endoscopic control. Methods We retrospectively evaluated a prospectively collected database on 115 SPS patients undergoing surveillance at Indiana University Hospital between June 2005 and May 2018. The endoscopist provided surveillance interval recommendations based on polyp burden. Endoscopic control was considered successful if surveillance examinations exhibited fewer polyps and if no or only an occasional polyp ≥1 cm in size was present at follow-up. Initial control was designated the clearing phase and the maintenance phase was surveillance after control was established. Results In total, 87 patients (75.7%) achieved endoscopic control, with some others in the clearing phase at this writing. Achieving control required a mean of 2.84 colonoscopies (including the baseline) over 20.4 months and a mean total 27.9 polyp resections. After establishing control, 71 patients were recommended to receive ≥24-month follow-up. Of those, 60 patients (69.0% of patients with initial control) continued surveillance at our center. The mean interval between colonoscopies during maintenance was 19.3 months with 6.74 mean polypectomies per procedure on polyps primarily <1 cm. There were no incident cancers or colon surgeries during maintenance. Conclusion Most patients achieved control of polyp burden with 2 to 3 colonoscopies over 1 to 2 years. After reaching control, 60 patients returned at intervals up to 24 months with no incident cancers and no surgeries required. Expansion of surveillance intervals to 24 months is effective and safe for many SPS patients who reach control of polyp burden.
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    Endoscopic management of large ileocecal valve lesions over an 18-year interval
    (Thieme Open, 2019) Ponugoti, Prasanna L.; Broadley, Heather M.; Garcia, Jonathan; Rex, Douglas K.; Medicine, School of Medicine
    Background and study aims Ileocecal valve (ICV) lesions are challenging to remove endoscopically. Patients and methods This was a retrospective cohort study, performed at an academic tertiary US hospital. Sessile polyps or flat ICV lesions ≥ 20 mm in size referred for endoscopic mucosal resection (EMR) were included. Successful resection rates, complication rates and recurrence were compared to lesions ≥ 20 mm in size not located on the ICV. Results During an 18-year interval, there were 118 ICV lesions ≥ 20 mm with mean size 28.6 mm (44.9 % females; mean age 71.6 years), comprising 9.03 % of all referred polyps. Ninety ICV lesions (76.3 %) were resected endoscopically, compared to 91.3 % of non-ICV lesions (P < 0.001). However, in the most recent 8 years, successful EMR of ICV lesions increased to 93 %. Conventional adenomas comprised 92.2 % of ICV lesions and 7.8 % were serrated. Delayed hemorrhage and perforation occurred in 3.3 % and 0 % of ICV lesions, respectively, compared to 4.8 % and 0.5 % in the non-ICV group. At first follow-up, rates of residual polyp in the ICV and non-ICV groups were 16.5 % and 13.6 %, respectively (P = 0.485). At second follow-up residual rates in the ICV and non-ICV lesion groups were 18.6 % and 6.7 %, respectively (P = .005). Conclusions Large ICV polyps are a common source of tertiary referrals. Over an 18-year experience, risk of EMR for ICV polyps was numerically lower, and risk of recurrence was numerically higher at first follow and significantly higher at second follow-up compared to non-ICV polyps.
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    Faster colonoscope withdrawal time without impaired detection using EndoRings
    (Thieme, 2018-08) Thygesen, John C.; Ponugoti, Prasanna; Tippins, William W.; Garcia, Jonathan R.; Sullivan, Andrew W.; Broadley, Heather M.; Rex, Douglas K.; Medicine, School of Medicine
    Background and study aims:  Mucosal exposure devices on the colonoscope tip have improved detection. We evaluated detection and procedure times in colonoscopies performed with EndoRings. Patients and methods:  We had 14 endoscopists in a university practice trial EndoRings. We compared detection and procedure times to age- and indication-matched procedures by the same endoscopists. Results:  There were 137 procedures with EndoRings. The adenoma detection rate was 44 % with EndoRings vs. 39 % without ( P  = 0.39). Mean adenomas per colonoscopy (standard deviation) was 1.2 (2.3) with EndoRings vs. 0.9 (1.6) without ( P  = 0.055). Mean insertion time with EndoRings was 6.2 (3.2) minutes vs. 6.6 (6.7) minutes without ( P  = 0.81). Mean withdrawal time with EndoRings in all patients with or without polypectomy was 12.2 (5.3) minutes and 16.1 (10.3) minutes without ( P  = 0.0005). Conclusion:  EndoRings may allow faster withdrawal during colonoscopy without any reduction in detection. Prospective trials with mucosal exposure devices targeting procedure times as primary endpoints are warranted.
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    High-definition colonoscopy versus Endocuff versus EndoRings versus Full-Spectrum Endoscopy for adenoma detection at colonoscopy: a multicenter randomized trial
    (Elsevier, 2018) Rex, Douglas K.; Repici, Alessandro; Gross, Seth A.; Hassan, Cesare; Ponugoti, Prasanna L.; Garcia, Jonathan R.; Broadley, Heather M.; Thygesen, Jack C.; Sullivan, Andrew W.; Tippins, William W.; Main, Samuel A.; Eckert, George J.; Vemulapalli, Krishna C.; Medicine, School of Medicine
    Background Devices used to improve polyp detection during colonoscopy have seldom been compared with each other. Methods We performed a 3-center prospective randomized trial comparing high-definition (HD) forward-viewing colonoscopy alone to HD with Endocuff to HD with EndoRings to the Full Spectrum Endoscopy (FUSE) system. Patients were age ≥50 years and had routine indications and intact colons. The study colonoscopists were all proven high-level detectors. The primary endpoint was adenomas per colonoscopy (APC) Results Among 1,188 patients who completed the study, APC with Endocuff (APC Mean ± SD 1.82 ± 2.58), EndoRings (1.55 ± 2.42), and standard HD colonoscopy (1.53 ± 2.33) were all higher than FUSE (1.30 ± 1.96,) (p<0.001 for APC). Endocuff was higher than standard HD colonoscopy for APC (p=0.014) . Mean cecal insertion times with FUSE (468 ± 311 seconds) and EndoRings (403 ± 263 seconds) were both longer than with Endocuff (354 ± 216 seconds) (p=0.006 and 0.018, respectively). Conclusions For high-level detectors at colonoscopy, forward-viewing HD instruments dominate the FUSE system, indicating that for these examiners image resolution trumps angle of view. Further, Endocuff is a dominant strategy over EndoRings and no mucosal exposure device on a forward-viewing HD colonoscope.
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    SIC-8000 versus hetastarch as a submucosal injection fluid for endoscopic mucosal resection: a randomized controlled trial
    (Elsevier, 2019) Rex, Douglas K.; Broadley, Heather M.; Garcia, Jonathan R.; Lahr, Rachel E.; MacPhail, Margaret E.; McWhinney, Connor D.; Searight, Meghan P.; Sullivan, Andrew W.; Mahajan, Neal; Eckert, George J.; Vemulapalli, Krishna C.; Medicine, School of Medicine
    Background and Aims Viscous solutions provide a superior submucosal cushion for endoscopic mucosal resection (EMR). SIC-8000 (Eleview, Aries Pharmaceuticals, La Jolla, Calif) is a commercially available FDA approved solution but hetastarch is also advocated. We performed a randomized trial comparing SIC-8000 to hetastarch as submucosal injection agents for colorectal EMR. Methods This was a single-center double-blinded randomized controlled trial performed at a tertiary referral center. Patients were referred to our center with flat or sessile lesions measuring ≥15 mm in size. The primary outcome measures were the Sydney Resection Quotient (SRQ) and the rate of en bloc resections. Secondary outcomes were total volume needed for a sufficient lift, number of resected pieces, and adverse events. Results There were 158 patients with 159 adenomas (84 SIC-8000 and 75 hetastarch) and 57 serrated lesions (30 SIC-8000 and 27 hetastarch). SRQ was significantly better in the SIC-8000 group compared with hetastarch group (9.3 vs 8.1, p=0.001). There was no difference in the proportion of lesions with en bloc resections. The total volume of injectate was significantly lower with SIC-8000 (14.8 mL vs 20.6 mL, p=0.038) Conclusions SIC-8000 is superior to hetastarch for use during EMR in terms of SRQ and total volume needed, although the absolute differences were small.