Browsing by Author "Khashab, Mouen"

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    Clip Closure Does Not Reduce Risk of Bleeding After Resection of Large Serrated Polyps: Results From a Randomized Trial
    (Elsevier, 2021-12) Crockett, Seth D.; Khashab, Mouen; Rex, Douglas K.; Grimm, Ian S.; Moyer, Matthew T.; Rastogi, Amit; Mackenzie, Todd A.; Pohl, Heiko; Medicine, School of Medicine
    Background & Aims Serrated polyps are important colorectal cancer precursors and are most commonly located in the proximal colon, where post-polypectomy bleeding rates are higher. There is limited clinical trial evidence to guide best practices for resection of large serrated polyps (LSPs). Methods In a multicenter trial, patients with large (≥20 mm) non-pedunculated polyps undergoing endoscopic mucosal resection (EMR) were randomized to clipping of the resection base or no clipping. This analysis is stratified by histologic subtype of study polyp(s), categorized as serrated [sessile serrated lesions (SSLs) or hyperplastic polyps (HPs)] or adenomatous, comparing clip vs control groups. The primary outcome was severe post-procedure bleeding within 30 days of colonoscopy. Results A total of 179 participants with 199 LSPs (191 SSLs and 8 HPs) and 730 participants with 771 adenomatous polyps were included in the study. Overall, 5 patients with LSPs (2.8%) experienced post-procedure bleeding compared with 42 (5.8%) of those with adenomas. There was no difference in post-procedure bleeding rates between patients in the clip vs control group among those with LSPs (2.3% vs 3.3%, respectively, difference 1.0%; P = NS). However, among those with adenomatous polyps, clipping was associated with a lower risk of post-procedure bleeding (3.9% vs 7.6%, difference 3.7%; P = .03) and overall serious adverse events (5.5% vs 10.6%, difference 5.1%; P = .01). Conclusion The post-procedure bleeding risk for LSPs removed via EMR is low, and there is no discernable benefit of prophylactic clipping of the resection base in this group. This study indicates that the benefit of endoscopic clipping following EMR may be specific for >2 cm adenomatous polyps located in the proximal colon. ClinicalTrials.gov, Number: NCT01936948.
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    Design and validation of a therapeutic EUS training program using a live animal model: Taking training to the next level
    (Wolters Kluwer, 2022) Sosa-Valencia, Leonardo; Huppertz, Jerôme; Wanert, Fanélie; Haberzetser, Francois; Swanström, Lee; Mangiavillano, Benedetto; Eisendrath, Pierre; Deprez, Pierre; Robles-Medranda, Carlos; Carrara, Silvia; Al-Haddad, Mohammad A.; Vilmann, Peter; Koch, Stephane; Larghi, Alberto; Khashab, Mouen; Medicine, School of Medicine
    Background and objectives: EUS has evolved into a therapeutic modality for gastrointestinal disorders. Simulators, ex vivo models, and phantoms are the current teaching methods for therapeutic EUS (TEUS). We create and evaluate a high-fidelity simulated live animal model (HiFi SAM) for teaching endoscopists TEUS. Materials and methods: Designing a curriculum that uses HiFi SAM and enables trainees to perform realistic procedures with expert mentors. Results: Twenty-seven trainees participated in a 3-day program with 6 h of theoretical and 14 h of hands using life HiFi SAM. Eighteen experts participated. Twenty-two (20-25) TEUS were defined for each HiFi SAM, and 616 were performed in all. Of 616/264 (43%) were evaluated with a mean of 88 per course (ranging between 80 and 95). Ninety-one percent (240/264) of the procedures were completed successfully. In 24, success was not achieved due to technical and/or model problems. Student rating of HiFi SAM was: 71% excellent rating (scale 8-10) and 95% excellent/good. The HiFi SAM procedure evaluation was (scale 1-5): fine-needle biopsy: 4.79, radiofrequency: 4.76, common bile duct and gallbladder drainage: 4.75, cystic drainages: 4.72, neurolysis: 4.55, microbiopsy: 4.50, and hepatogastric drainage: 4.04, with an overall satisfaction rate of 4.56 (91%). A short survey showed: 83% would recommend absolutely (17% most likely), 33% think that ITEC training was sufficient for their practice, and 66% would like additional training, especially more practice in specific techniques rather than more clinical case discussion. Regarding impact on their practice, 66% of the trainees started a new procedure and/or noted improvement in previous ones. Conclusion: HiFi SAM is a complex model; however, experts and trainees are satisfied with the training this new curriculum provided.
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    Snare Tip Soft Coagulation vs Argon Plasma Coagulation vs No Margin Treatment After Large Nonpedunculated Colorectal Polyp Resection: a Randomized Trial
    (Elsevier, 2023) Rex, Douglas K.; Haber, Gregory B.; Khashab, Mouen; Rastogi, Amit; Hasan, Muhammad K.; DiMaio, Christopher J.; Kumta, Nikhil A.; Nagula, Satish; Gordon, Stuart; Al-Kawas, Firas; Waye, Jerome D.; Razjouyan, Hadie; Dye, Charles E.; Moyer, Matthew T.; Shultz, Jeremiah; Lahr, Rachel E.; Yuen, Poi Yu Sofia; Dixon, Rebekah; Boyd, LaKeisha; Pohl, Heiko; Medicine, School of Medicine
    Background & Aims Thermal treatment of the defect margin after endoscopic mucosal resection (EMR) of large nonpedunculated colorectal lesions reduces the recurrence rate. Both snare tip soft coagulation (STSC) and argon plasma coagulation (APC) have been used for thermal margin treatment, but there are few data directly comparing STSC with APC for this indication. Methods We performed a randomized 3-arm trial in 9 US centers comparing STSC with APC with no margin treatment (control) of defects after EMR of colorectal nonpedunculated lesions ≥15 mm. The primary end point was the presence of residual lesion at first follow-up. Results There were 384 patients and 414 lesions randomized, and 308 patients (80.2%) with 328 lesions completed ≥1 follow-up. The proportion of lesions with residual polyp at first follow-up was 4.6% with STSC, 9.3% with APC, and 21.4% with control subjects (no margin treatment). The odds of residual polyp at first follow-up were lower for STSC and APC when compared with control subjects (P = .001 and P = .01, respectively). The difference in odds was not significant between STSC and APC. STSC took less time to apply than APC (median, 3.35 vs 4.08 minutes; P = .019). Adverse event rates were low, with no difference between arms. Conclusions In a randomized trial STSC and APC were each superior to no thermal margin treatment after EMR. STSC was faster to apply than APC. Because STSC also results in lower cost and plastic waste than APC (APC requires an additional device), our study supports STSC as the preferred thermal margin treatment after colorectal EMR.