Browsing by Author "Pohl, Heiko"
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Item Baseline Features and Reasons for Nonparticipation in the Colonoscopy Versus Fecal Immunochemical Test in Reducing Mortality From Colorectal Cancer (CONFIRM) Study, a Colorectal Cancer Screening Trial(American Medical Association, 2023-07-03) Robertson, Douglas J.; Dominitz, Jason A.; Beed, Alexander; Boardman, Kathy D.; Del Curto, Barbara J.; Guarino, Peter D.; Imperiale, Thomas F.; LaCasse, Andrew; Larson, Meaghan F.; Gupta, Samir; Lieberman, David; Planeta, Beata; Shaukat, Aasma; Sultan, Shanaz; Menees, Stacy B.; Saini, Sameer D.; Schoenfeld, Philip; Goebel, Stephan; von Rosenvinge, Erik C.; Baffy, Gyorgy; Halasz, Ildiko; Pedrosa, Marcos C.; Kahng, Lyn Sue; Cassim, Riaz; Greer, Katarina B.; Kinnard, Margaret F.; Bhatt, Divya B.; Dunbar, Kerry B.; Harford, William V.; Mengshol, John A.; Olson, Jed E.; Patel, Swati G.; Antaki, Fadi; Fisher, Deborah A.; Sullivan, Brian A.; Lenza, Christopher; Prajapati, Devang N.; Wong, Helen; Beyth, Rebecca; Lieb, John G.; Manlolo, Joseph; Ona, Fernando V.; Cole, Rhonda A.; Khalaf, Natalia; Kahi, Charles J.; Kohli, Divyanshoo Rai; Rai, Tarun; Sharma, Prateek; Anastasiou, Jiannis; Hagedorn, Curt; Fernando, Ronald S.; Jackson, Christian S.; Jamal, M. Mazen; Lee, Robert H.; Merchant, Farrukh; May, Folasade P.; Pisegna, Joseph R.; Omer, Endashaw; Parajuli, Dipendra; Said, Adnan; Nguyen, Toan D.; Tombazzi, Claudio Ruben; Feldman, Paul A.; Jacob, Leslie; Koppelman, Rachel N.; Lehenbauer, Kyle P.; Desai, Deepak S.; Madhoun, Mohammad F.; Tierney, William M.; Ho, Minh Q.; Hockman, Heather J.; Lopez, Christopher; Carter Paulson, Emily; Tobi, Martin; Pinillos, Hugo L.; Young, Michele; Ho, Nancy C.; Mascarenhas, Ranjan; Promrat, Kirrichai; Mutha, Pritesh R.; Pandak, William M.; Shah, Tilak; Schubert, Mitchell; Pancotto, Frank S.; Gawron, Andrew J.; Underwood, Amelia E.; Ho, Samuel B.; Magno-Pagatzaurtundua, Priscilla; Toro, Doris H.; Beymer, Charles H.; Kaz, Andrew M.; Elwing, Jill; Gill, Jeffrey A.; Goldsmith, Susan F.; Yao, Michael D.; Protiva, Petr; Pohl, Heiko; Kyriakides, Tassos; CONFIRM Study Group; Medicine, School of MedicineImportance: The Colonoscopy Versus Fecal Immunochemical Test in Reducing Mortality From Colorectal Cancer (CONFIRM) randomized clinical trial sought to recruit 50 000 adults into a study comparing colorectal cancer (CRC) mortality outcomes after randomization to either an annual fecal immunochemical test (FIT) or colonoscopy. Objective: To (1) describe study participant characteristics and (2) examine who declined participation because of a preference for colonoscopy or stool testing (ie, fecal occult blood test [FOBT]/FIT) and assess that preference's association with geographic and temporal factors. Design, setting, and participants: This cross-sectional study within CONFIRM, which completed enrollment through 46 Department of Veterans Affairs medical centers between May 22, 2012, and December 1, 2017, with follow-up planned through 2028, comprised veterans aged 50 to 75 years with an average CRC risk and due for screening. Data were analyzed between March 7 and December 5, 2022. Exposure: Case report forms were used to capture enrolled participant data and reasons for declining participation among otherwise eligible individuals. Main outcomes and measures: Descriptive statistics were used to characterize the cohort overall and by intervention. Among individuals declining participation, logistic regression was used to compare preference for FOBT/FIT or colonoscopy by recruitment region and year. Results: A total of 50 126 participants were recruited (mean [SD] age, 59.1 [6.9] years; 46 618 [93.0%] male and 3508 [7.0%] female). The cohort was racially and ethnically diverse, with 748 (1.5%) identifying as Asian, 12 021 (24.0%) as Black, 415 (0.8%) as Native American or Alaska Native, 34 629 (69.1%) as White, and 1877 (3.7%) as other race, including multiracial; and 5734 (11.4%) as having Hispanic ethnicity. Of the 11 109 eligible individuals who declined participation (18.0%), 4824 (43.4%) declined due to a stated preference for a specific screening test, with FOBT/FIT being the most preferred method (2820 [58.5%]) vs colonoscopy (1958 [40.6%]; P < .001) or other screening tests (46 [1.0%] P < .001). Preference for FOBT/FIT was strongest in the West (963 of 1472 [65.4%]) and modest elsewhere, ranging from 199 of 371 (53.6%) in the Northeast to 884 of 1543 (57.3%) in the Midwest (P = .001). Adjusting for region, the preference for FOBT/FIT increased by 19% per recruitment year (odds ratio, 1.19; 95% CI, 1.14-1.25). Conclusions and relevance: In this cross-sectional analysis of veterans choosing nonenrollment in the CONFIRM study, those who declined participation more often preferred FOBT or FIT over colonoscopy. This preference increased over time and was strongest in the western US and may provide insight into trends in CRC screening preferences.Item 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 MedicineBackground & 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.Item Clip Closure Prevents Bleeding After Endoscopic Resection of Large Colon Polyps in a Randomized Trial(Elsevier, 2019-10) Pohl, Heiko; Grimm, Ian S.; Moyer, Matthew T.; Hasan, Muhammad K.; Pleskow, Douglas; Elmunzer, B. Joseph; Khashab, Mouen A.; Sanaei, Omid; Al-Kawas, Firas H.; Gordon, Stuart R.; Mathew, Abraham; Levenick, John M.; Aslanian, Harry R.; Antaki, Fadi; von Renteln, Daniel; Crockett, Seth D.; Rastogi, Amit; Gill, Jeffrey A.; Law, Ryan J.; Elias, Pooja A.; Pellise, Maria; Wallace, Michael B.; Mackenzie, Todd A.; Rex, Douglas K.; Medicine, School of MedicineBackground & aims: Bleeding is the most common severe complication after endoscopic mucosal resection of large colon polyps and is associated with significant morbidity and cost. We examined whether prophylactic closure of the mucosal defect with hemoclips after polyp resection reduces the risk of bleeding. Methods: We performed a multicenter, randomized trial of patients with a large nonpedunculated colon polyp (≥20 mm) at 18 medical centers in North America and Spain from April 2013 through October 2017. Patients were randomly assigned to groups that underwent endoscopic closure with a clip (clip group) or no closure (control group) and followed. The primary outcome, postprocedure bleeding, was defined as a severe bleeding event that required hospitalization, a blood transfusion, colonoscopy, surgery, or another invasive intervention within 30 days after completion of the colonoscopy. Subgroup analyses included postprocedure bleeding with polyp location, polyp size, or use of periprocedural antithrombotic medications. We also examined the risk of any serious adverse event. Results: A total of 919 patients were randomly assigned to groups and completed follow-up. Postprocedure bleeding occurred in 3.5% of patients in the clip group and 7.1% in the control group (absolute risk difference [ARD] 3.6%; 95% confidence interval [CI] 0.7%-6.5%). Among 615 patients (66.9%) with a proximal large polyp, the risk of bleeding in the clip group was 3.3% and in the control group was 9.6% (ARD 6.3%; 95% CI 2.5%-10.1%); among patients with a distal large polyp, the risks were 4.0% in the clip group and 1.4% in the control group (ARD -2.6%; 95% CI -6.3% to -1.1%). The effect of clip closure was independent of antithrombotic medications or polyp size. Serious adverse events occurred in 4.8% of patients in the clip group and 9.5% of patients in the control group (ARD 4.6%; 95% CI 1.3%-8.0%). Conclusions: In a randomized trial, we found that endoscopic clip closure of the mucosal defect following resection of large colon polyps reduces risk of postprocedure bleeding. The protective effect appeared to be restricted to large polyps located in the proximal colon.Item Cold versus hot snare resection with or without submucosal injection of 6-15 mm colorectal polyps: a randomized controlled trial(ScienceDirect, 2022) Rex, Douglas K.; Anderson, Joseph C.; Pohl, Heiko; Lahr, Rachel E.; Judd, Stephanie; Antaki, Fadi; Lilley, Kirthi; Castelluccio., Peter F.; Vemulapalli, Krishna C.; Medicine, School of MedicineBackground and aims Cold snare resection of colorectal lesions has been found safe and effective for an expanding set of colorectal lesions. In this study, we sought to understand the efficacy of simple cold snare resection and cold endoscopic mucosal resection (EMR), versus hot snare resection and hot EMR for colorectal lesions 6-15 mm in size. Methods At three U.S. centers, 235 patients with 286 colorectal lesions 6-15 mm in size were randomized to cold snaring, cold EMR, hot snaring, or hot EMR for non-pedunculated colorectal lesions 6-15 mm in size. The primary outcome was complete resection determined by 4 biopsies from the defect margin and 1 biopsy from the center of the resection defect. Results The overall incomplete resection rate was 2.4% (95% CI 0.8-7.5%). All 7 incompletely removed polyps were 10-15 mm in size and removed by hot EMR (n = 4, 6.2%), hot snare (n = 2, 2.2%), or cold EMR (n = 1, 1.8%). Cold snaring had no incomplete resections, required less procedural time than the other methods, and was not associated with serious adverse events. Conclusion Cold snaring is a dominant resection technique for non-pedunculated colorectal lesions 6-15 mm in size.Item Colonoscopy and Colorectal Cancer Mortality in the Veterans Affairs Health Care System: A Case–Control Study(ACP, 2018-04) Kahi, Charles J.; Pohl, Heiko; Myers, Laura J.; Mobarek, Dalia; Robertson, Douglas J.; Imperiale, Thomas F.; Medicine, School of MedicineBackground: Colonoscopy is widely used in the Veterans Affairs (VA) health care system for colorectal cancer (CRC) prevention, but its effect on CRC mortality is unknown. Objective: To determine whether colonoscopy is associated with decreased CRC mortality in veterans and whether its effect differs by anatomical location of CRC. Design: Case–control study. Setting: VA–Medicare administrative data. Participants: Case patients were veterans aged 52 years or older who were diagnosed with CRC between 2002 and 2008 and died of the disease by the end of 2010. Case patients were matched to 4 control patients without prior CRC on the basis of age, sex, and facility. Conditional logistic regression was performed to calculate odds ratios (ORs) for exposure to colonoscopy, with adjustment for race, Charlson Comorbidity Index score, selected chronic conditions, nonsteroidal anti-inflammatory drug use, and family history of CRC. Measurements: Exposure to colonoscopy was determined from 1997 to 6 months before CRC diagnosis in case patients and to a corresponding date in control patients. Subgroup analysis was performed for patients who had undergone screening colonoscopy. Results: A total of 4964 case patients and 19 856 control patients were identified. Case patients were significantly less likely to have undergone any colonoscopy (OR, 0.39 [95% CI, 0.35 to 0.43]). Colonoscopy was associated with reduced mortality for left-sided cancer (OR, 0.28 [CI, 0.24 to 0.32]) and right-sided cancer (OR, 0.54 [CI, 0.47 to 0.63]). The results were similar for patients who had undergone screening colonoscopy (overall OR, 0.30 [CI, 0.24 to 0.38]). Sensitivity analyses that varied the interval between CRC diagnosis and colonoscopy exposure did not affect the primary findings. Limitation: Unmeasured confounding. Conclusion: In this study using national VA–Medicare data, colonoscopy was associated with significant reductions in CRC mortality among veterans and was associated with greater benefit for left-sided cancer than right-sided cancer.Item Digestive Manifestations in Patients Hospitalized With Coronavirus Disease 2019(Elsevier, 2020-10-01) Elmunzer, B. Joseph; Spitzer, Rebecca L.; Foster, Lydia D.; Merchant, Ambreen A.; Howard, Eric F.; Patel, Vaishali A.; West, Mary K.; Qayed, Emad; Nustas, Rosemary; Zakaria, Ali; Piper, Marc S.; Taylor, Jason R.; Jaza, Lujain; Forbes, Nauzer; Chau, Millie; Lara, Luis F.; Papachristou, Georgios I.; Volk, Michael L.; Hilson, Liam G.; Zhou, Selena; Kushnir, Vladimir M.; Lenyo, Alexandria M.; McLeod, Caroline G.; Amin, Sunil; Kuftinec, Gabriela N.; Yadav, Dhiraj; Fox, Charlie; Kolb, Jennifer M.; Pawa, Swati; Pawa, Rishi; Canakis, Andrew; Huang, Christopher; Jamil, Laith H.; Aneese, Andrew M.; Glamour, Benita K.; Smith, Zachary L.; Hanley, Katherine A.; Wood, Jordan; Patel, Harsh K.; Shah, Janak N.; Agarunov, Emil; Sethi, Amrita; Fogel, Evan L.; McNulty, Gail; Haseeb, Abdul; Trieu, Judy A.; Dixon, Rebekah E.; Yang, Jeong Yun; Mendelsohn, Robin B.; Calo, Delia; Aroniadis, Olga C.; LaComb, Joseph F.; Scheiman, James M.; Sauer, Bryan G.; Dang, Duyen T.; Piraka, Cyrus R.; Shah, Eric D.; Pohl, Heiko; Tierney, William M.; Mitchell, Stephanie; Condon, Ashwinee; Lenhart, Adrienne; Dua, Kulwinder S.; Kanagala, Vikram S.; Kamal, Ayesha; Singh, Vikesh K.; Pinto-Sanchez, Maria Ines; Hutchinson, Joy M.; Kwon, Richard S.; Korsnes, Sheryl J.; Singh, Harminder; Solati, Zahra; Willingham, Field F.; Yachimski, Patrick S.; Conwell, Darwin L.; Mosier, Evan; Azab, Mohamed; Patel, Anish; Buxbaum, James; Wani, Sachin; Chak, Amitabh; Hosmer, Amy E.; Keswani, Rajesh N.; DiMaio, Christopher J.; Bronze, Michael S.; Muthusamy, Raman; Canto, Marcia I.; Gjeorgjievski, V. Mihajlo; Imam, Zaid; Odish, Fadi; Edhi, Ahmed I.; Orosey, Molly; Tiwari, Abhinav; Patwardhan, Soumil; Brown, Nicholas G.; Patel, Anish A.; Ordiah, Collins O.; Sloan, Ian P.; Cruz, Lilian; Koza, Casey L.; Okafor, Uchechi; Hollander, Thomas; Furey, Nancy; Reykhart, Olga; Zbib, Natalia H.; Damianos, John A.; Esteban, James; Hajidiacos, Nick; Saul, Melissa; Mays, Melanie; Anderson, Gulsum; Wood, Kelley; Mathews, Laura; Diakova, Galina; Caisse, Molly; Wakefield, Lauren; Nitchie, Haley; Waljee, Akbar K.; Tang, Weijing; Zhang, Yueyang; Zhu, Ji; Deshpande, Amar R.; Rockey, Don C.; Alford, Teldon B.; Durkalski, Valerie; Medicine, School of MedicineBackground & Aims The prevalence and significance of digestive manifestations in coronavirus disease 2019 (COVID-19) remain uncertain. We aimed to assess the prevalence, spectrum, severity, and significance of digestive manifestations in patients hospitalized with COVID-19. Methods Consecutive patients hospitalized with COVID-19 were identified across a geographically diverse alliance of medical centers in North America. Data pertaining to baseline characteristics, symptomatology, laboratory assessment, imaging, and endoscopic findings from the time of symptom onset until discharge or death were abstracted manually from electronic health records to characterize the prevalence, spectrum, and severity of digestive manifestations. Regression analyses were performed to evaluate the association between digestive manifestations and severe outcomes related to COVID-19. Results A total of 1992 patients across 36 centers met eligibility criteria and were included. Overall, 53% of patients experienced at least 1 gastrointestinal symptom at any time during their illness, most commonly diarrhea (34%), nausea (27%), vomiting (16%), and abdominal pain (11%). In 74% of cases, gastrointestinal symptoms were judged to be mild. In total, 35% of patients developed an abnormal alanine aminotransferase or total bilirubin level; these were increased to less than 5 times the upper limit of normal in 77% of cases. After adjusting for potential confounders, the presence of gastrointestinal symptoms at any time (odds ratio, 0.93; 95% CI, 0.76–1.15) or liver test abnormalities on admission (odds ratio, 1.31; 95% CI, 0.80–2.12) were not associated independently with mechanical ventilation or death. Conclusions Among patients hospitalized with COVID-19, gastrointestinal symptoms and liver test abnormalities were common, but the majority were mild and their presence was not associated with a more severe clinical course.Item Digestive Manifestations in Patients Hospitalized With Coronavirus Disease 2019(Elsevier, 2021-07) Elmunzer, B. Joseph; Spitzer, Rebecca L.; Foster, Lydia D.; Merchant, Ambreen A.; Howard, Eric F.; Patel, Vaishali A.; West, Mary K.; Qayed, Emad; Nustas, Rosemary; Zakaria, Ali; Piper, Marc S.; Taylor, Jason R.; Jaza, Lujain; Forbes, Nauzer; Chau, Millie; Lara, Luis F.; Papachristou, Georgios I.; Volk, Michael L.; Hilson, Liam G.; Zhou, Selena; Kushnir, Vladimir M.; Lenyo, Alexandria M.; McLeod, Caroline G.; Amin, Sunil; Kuftinec, Gabriela N.; Yadav, Dhiraj; Fox, Charlie; Kolb, Jennifer M.; Pawa, Swati; Pawa, Rishi; Canakis, Andrew; Huang, Christopher; Jamil, Laith H.; Aneese, Andrew M.; Glamour, Benita K.; Smith, Zachary L.; Hanley, Katherine A.; Wood, Jordan; Patel, Harsh K.; Shah, Janak N.; Agarunov, Emil; Sethi, Amrita; Fogel, Evan L.; McNulty, Gail; Haseeb, Abdul; Trieu, Judy A.; Dixon, Rebekah E.; Yang, Jeong Yun; Mendelsohn, Robin B.; Calo, Delia; Aroniadis, Olga C.; LaComb, Joseph F.; Scheiman, James M.; Sauer, Bryan G.; Dang, Duyen T.; Piraka, Cyrus R.; Shah, Eric D.; Pohl, Heiko; Tierney, William M.; Mitchell, Stephanie; Condon, Ashwinee; Lenhart, Adrienne; Dua, Kulwinder S.; Kanagala, Vikram S.; Kamal, Ayesha; Singh, Vikesh K.; Pinto-Sanchez, Maria Ines; Hutchinson, Joy M.; Kwon, Richard S.; Korsnes, Sheryl J.; Singh, Harminder; Solati, Zahra; Willingham, Field F.; Yachimski, Patrick S.; Conwell, Darwin L.; Mosier, Evan; Azab, Mohamed; Patel, Anish; Buxbaum, James; Wani, Sachin; Chak, Amitabh; Hosmer, Amy E.; Keswani, Rajesh N.; DiMaio, Christopher J.; Bronze, Michael S.; Muthusamy, Raman; Canto, Marcia I.; Gjeorgjievski, V. Mihajlo; Imam, Zaid; Odish, Fadi; Edhi, Ahmed I.; Orosey, Molly; Tiwari, Abhinav; Patwardhan, Soumil; Brown, Nicholas G.; Patel, Anish A.; Ordiah, Collins O.; Sloan, Ian P.; Cruz, Lilian; Koza, Casey L.; Okafor, Uchechi; Hollander, Thomas; Furey, Nancy; Reykhart, Olga; Zbib, Natalia H.; Damianos, John A.; Esteban, James; Hajidiacos, Nick; Saul, Melissa; Mays, Melanie; Anderson, Gulsum; Wood, Kelley; Mathews, Laura; Diakova, Galina; Caisse, Molly; Wakefield, Lauren; Nitchie, Haley; Waljee, Akbar K.; Tang, Weijing; Zhang, Yueyang; Zhu, Ji; Deshpande, Amar R.; Rockey, Don C.; Alford, Teldon B.; Durkalski, Valerie; North American Alliance for the Study of Digestive Manifestations of COVID-19; Medicine, School of MedicineBACKGROUND & AIMS: The prevalence and significance of digestive manifestations in coronavirus disease 2019 (COVID-19) remain uncertain. We aimed to assess the prevalence, spectrum, severity, and significance of digestive manifestations in patients hospitalized with COVID-19. METHODS: Consecutive patients hospitalized with COVID-19 were identified across a geographically diverse alliance of medical centers in North America. Data pertaining to baseline characteristics, symptomatology, laboratory assessment, imaging, and endoscopic findings from the time of symptom onset until discharge or death were abstracted manually from electronic health records to characterize the prevalence, spectrum, and severity of digestive manifestations. Regression analyses were performed to evaluate the association between digestive manifestations and severe outcomes related to COVID-19. RESULTS: A total of 1992 patients across 36 centers met eligibility criteria and were included. Overall, 53% of patients experienced at least 1 gastrointestinal symptom at any time during their illness, most commonly diarrhea (34%), nausea (27%), vomiting (16%), and abdominal pain (11%). In 74% of cases, gastrointestinal symptoms were judged to be mild. In total, 35% of patients developed an abnormal alanine aminotransferase or total bilirubin level; these were increased to less than 5 times the upper limit of normal in 77% of cases. After adjusting for potential confounders, the presence of gastrointestinal symptoms at any time (odds ratio, 0.93; 95% CI, 0.76-1.15) or liver test abnormalities on admission (odds ratio, 1.31; 95% CI, 0.80-2.12) were not associated independently with mechanical ventilation or death. CONCLUSIONS: Among patients hospitalized with COVID-19, gastrointestinal symptoms and liver test abnormalities were common, but the majority were mild and their presence was not associated with a more severe clinical course.Item Effects of Blended (Yellow) vs Forced Coagulation (Blue) Currents on Adverse Events, Complete Resection, or Polyp Recurrence After Polypectomy in a Large Randomized Trial(Elsevier, 2020-07) Pohl, Heiko; Grimm, Ian S.; Moyer, Matthew T.; Hasan, Muhammad K.; Pleskow, Douglas; Elmunzer, B. Joseph; Khashab, Mouen A.; Sanaei, Omid; Al-Kawas, Firas H.; Gordon, Stuart R.; Mathew, Abraham; Levenick, John M.; Aslanian, Harry R.; Antaki, Fadi; von Renteln, Daniel; Crockett, Seth D.; Rastogi, Amit; Gill, Jeffrey A.; Law, Ryan J.; Elias, Pooja A.; Pellise, Maria; Mackenzie, Todd A.; Rex, Douglas K.; Medicine, School of MedicineBackground & aims: There is debate over the type of electrosurgical setting that should be used for polyp resection. Some endoscopists use a type of blended current (yellow), whereas others prefer coagulation (blue). We performed a single-blinded, randomized trial to determine whether type of electrosurgical setting affects risk of adverse events or recurrence. Methods: Patients undergoing endoscopic mucosal resection of nonpedunculated colorectal polyps 20 mm or larger (n = 928) were randomly assigned, in a 2 × 2 design, to groups that received clip closure or no clip closure of the resection defect (primary intervention) and then to either a blended current (Endocut Q) or coagulation current (forced coagulation) (Erbe Inc) (secondary intervention and focus of the study). The study was performed at multiple centers, from April 2013 through October 2017. Patients were evaluated 30 days after the procedure (n = 919), and 675 patients underwent a surveillance colonoscopy at a median of 6 months after the procedure. The primary outcome was any severe adverse event in a per patient analysis. Secondary outcomes were complete resection and recurrence at first surveillance colonoscopy in a per polyp analysis. Results: Serious adverse events occurred in 7.2% of patients in the Endocut group and 7.9% of patients in the forced coagulation group, with no significant differences in the occurrence of types of events. There were no significant differences between groups in proportions of polyps that were completely removed (96% in the Endocut group vs 95% in the forced coagulation group) or the proportion of polyps found to have recurred at surveillance colonoscopy (17% and 17%, respectively). Procedural characteristics were comparable, except that 17% of patients in the Endocut group had immediate bleeding that required an intervention, compared with 11% in the forced coagulation group (P = .006). Conclusions: In a randomized trial to compare 2 commonly used electrosurgical settings for the resection of large colorectal polyps (Endocut vs forced coagulation), we found no difference in risk of serious adverse events, complete resection rate, or polyp recurrence. Electrosurgical settings can therefore be selected based on endoscopist expertise and preference.Item GA White Paper: Challenges and Gaps in Innovation for the Performance of Colonoscopy for Screening and Surveillance of Colorectal Cancer(Elsevier, 2022) Komanduri, Srinadh; Dominitz, Jason A.; Rabeneck, Linda; Kahi, Charles; Ladabaum, Uri; Imperiale, Thomas F.; Byrne, Michael F.; Lee, Jeffrey K.; Lieberman, David; Wang, Andrew Y.; Sultan, Shahnaz; Pohl, Heiko; Muthusamy, V. Raman; Medicine, School of MedicineIn 2018 the American Gastroenterological Association’s (AGA) Center for GI Innovation and Technology (CGIT) convened a consensus conference, entitled, “Colorectal Cancer Screening and Surveillance: Role of Emerging Technology and Innovation to Improve Outcomes.” The conference participants, which included more than 60 experts in colorectal cancer (CRC), considered recent improvements in CRC screening rates and polyp detection, persistent barriers to colonoscopy uptake, and opportunities for performance improvement and innovation. This white paper originates from that conference. It aims to summarize current patient- and physician-centered gaps and challenges in colonoscopy, diagnostic and therapeutic challenges affecting colonoscopy uptake, and the potential use of emerging technologies and quality metrics to improve patient outcomes.Item Prophylactic Clipping After Colorectal Endoscopic Resection Prevents Bleeding of Large, Proximal Polyps: Meta-Analysis of Randomized Trials(Elsevier, 2020) Spadaccini, Marco; Albéniz, Eduardo; Pohl, Heiko; Maselli, Roberta; Chandrasekar, Viveksandeep Thoguluva; Correale, Loredana; Anderloni, Andrea; Carrara, Silvia; Fugazza, Alessandro; Badalamenti, Matteo; Iwatate, Mineo; Antonelli, Giulio; Enguita-Germán, Mónica; Álvarez, Marco Antonio; Sharma, Prateek; Rex, Douglas K.; Hassan, Cesare; Repici, Alessandro; Medicine, School of MedicineBackground & Aims The benefits of prophylactic clipping to prevent bleeding after polypectomy are unclear. We conducted an updated meta-analysis of randomized trials to assess the efficacy of clipping in preventing bleeding after polypectomy, overall and according to polyp size and location. Methods We searched the Medline/PubMed, EMBASE, and Scopus databases randomized trials that compared effects of clipping vs not clipping to prevent bleeding after polypectomy. We performed a random-effects meta-analysis to generate pooled relative risks (RRs) with 95% CIs. Multilevel random-effects meta-regression analysis was used to combine data on bleeding after polypectomy and estimate associations between rates of bleeding and polyp characteristics. Results We analyzed data from 9 trials, comprising 7197 colorectal lesions (22.5% 20 mm or larger, 49.2% with proximal location). Clipping, compared with no clipping, did not significantly reduce the overall risk of post-polypectomy bleeding (2.2% with clipping vs 3.3% with no clipping; RR, 0.69; 95% CI, 0.45–1.08; P=.072). Clipping significantly reduced risk of bleeding after removal of polyps that were 20 mm or larger (4.3% had bleeding after clipping vs 7.6% had bleeding with no clipping; RR, 0.51; 95% CI, 0.33–0.78; P=.020) or that were in a proximal location (3.0% had bleeding after clipping vs 6.2% had bleeding with no clipping; RR, 0.53; 95% CI, 0.35–0.81; P<.001). In multilevel meta-regression analysis that adjusted for polyp size and location, prophylactic clipping was significantly associated with reduced risk of bleeding after removal of large proximal polyps (RR, 0.37; 95% CI, 0.22–0.61; P=.021) but not small proximal lesions (RR, 0.88; 95% CI, 0.48–1.62; P=0.581). Conclusions In a meta-analysis of randomized trials, we found that routine use of prophylactic clipping does not reduce risk of post-polypectomy bleeding, overall. However, clipping appeared to reduce bleeding after removal of large (more than 20 mm), proximal lesions.