Research Spotlight

Baek, S. J., A. L. Lightner, S. Y. Boostrom, K. L. Mathis, R. R. Cima, J. H. Pemberton, D. W. Larson and E. J. Dozois (2017). “Functional outcomes following laparoscopic ileal pouch-anal anastomosis in patients with chronic ulcerative colitis: Long-term follow-up of a case-matched study.” J Gastrointest Surg 21(8): 1304-1308.

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BACKGROUND: Laparoscopic ileal pouch-anal anastomosis (L-IPAA) has been increasingly adopted over the last decade due to short-term patient-related benefits. Several studies have shown L-IPAA to be equivalent to open IPAA in terms of safety and short-term outcomes. However, few L-IPAA studies have examined long-term functional outcomes. We aimed to evaluate the long-term functional outcomes of L-IPAA as compared to open IPAA. METHODS: A previous case-matched cohort study at our institution compared short-term outcomes between L-IPAA and open IPAA from 1998 to 2004. For this study, we selected all patients from this case-matched cohort study with chronic ulcerative colitis (CUC) who had follow-up functional data of greater than 1 year. Functional data was obtained through prospective surveys, which were sent annually to all IPAA patients postoperatively. RESULTS: One hundred and forty-nine patients (58 L-IPAA, 91 open IPAA) with a median 8-year duration of follow-up were identified. There were no differences in demographics and long-term surgical outcomes between groups. Stapled anastomosis was more common in the laparoscopic group (91.4 versus 54.9%, p < 0.001). Stool frequency during daytime (>6 stools, L-IPAA 32.8%, open 49.4%, p = 0.048) and nighttime (>2 stools, L-IPAA 13.8%, open 30.6%; p = 0.024) was significantly lower in the L-IPAA group. Ability to differentiate gas from stool was not different (p = 0.13). Rate of complete continence was similar in L-IPAA and open groups (L-IPAA 36.2%, open 21.8%, p = 0.060). There was no difference in use of medication to control stools, perianal skin irritation, voiding difficulty, sexual problems, and occupational change between groups. Subgroup analysis to evaluate for any group differences attributable to anastomotic technique demonstrated only that stapled anastomoses lead to more perianal skin irritation in the L-IPAA group (L-IPAA = 60.4% versus open IPAA = 38.8%; p = 0.031). CONCLUSION: Overall, L-IPAA has comparable functional results to the open approach with slightly lower daytime and nighttime stool frequency. This difference may be attributed to a greater number of stapled anastomoses performed in the laparoscopic cohort.

Bagel, J., K. C. Duffin, A. Moore, L. K. Ferris, K. Siu, J. Steadman, F. Kianifard, J. Nyirady and M. Lebwohl (2017). “The effect of secukinumab on moderate-to-severe scalp psoriasis: Results of a 24-week, randomized, double-blind, placebo-controlled phase 3b study.” J Am Acad Dermatol: 2017 Aug [Epub ahead of print].

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BACKGROUND: Moderate-to-severe scalp psoriasis has not been evaluated in prospective trials of patients without moderate-to-severe body psoriasis. OBJECTIVE: Evaluate the efficacy and safety of secukinumab in moderate-to-severe scalp psoriasis. METHODS: In this 24-week, double-blind, phase 3b study, 102 patients were randomized 1:1 to subcutaneous secukinumab 300 mg or placebo at baseline, weeks 1, 2, and 3, and then every 4 weeks from week 4 to 20. The primary efficacy variable was 90% improvement of Psoriasis Scalp Severity Index (PSSI 90) score from baseline to week 12. RESULTS: At week 12, PSSI 90 (secukinumab 300 mg vs placebo, 52.9% vs 2.0%) and Investigator’s Global Assessment modified 2011 scalp responses of 0 or 1 (secukinumab 300 mg vs placebo, 56.9% vs 5.9%) were significantly greater with secukinumab 300 mg than placebo (P < .001 for both). In addition, significantly more patients achieved complete clearance of scalp psoriasis at week 12 with secukinumab 300 mg than placebo (35.3% vs 0%; P < .001). The median time to 50% reduction in PSSI score was 3.29 weeks with secukinumab 300 mg. The safety profile of secukinumab was consistent with previous phase 3 studies. LIMITATIONS: There was no active comparator arm. CONCLUSION: Secukinumab is efficacious and well-tolerated for patients with extensive moderate-to-severe scalp psoriasis.

Hirano, I., S. Spechler, G. Furuta and E. S. Dellon (2017). “White paper aga: Drug development for eosinophilic esophagitis.” Clin Gastroenterol Hepatol 15(8): 1173-1183.

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Since first characterized in 2 small case series in the early 1990s, eosinophilic esophagitis (EoE) has emerged as a commonly identified cause of esophageal symptoms in children and adults.1,2 Although several highly effectively dietary, pharmacologic, and endoscopic therapies have been reported, none is currently approved by either the US Food and Drug Administration (FDA) or European regulatory authorities. Evolving diagnostic criteria have challenged drug development, in particular the recognition of complex interactions with the most prevalent esophageal disorder, gastroesophageal reflux disease (GERD). Heterogeneity in the clinical presentations of affected children and adults has created difficulties with uniform inclusion criteria and the development of disease-specific, patient-reported outcome (PRO) instruments. Furthermore, controversies regarding the appropriate therapeutic endpoints of EoE have impeded the design of clinical trials. Despite these obstacles, collaborative efforts by investigators, industry, the FDA, and patient advocacy groups have resulted in substantial progress in drug development in EoE over the past 2 decades.3 The purpose of this article is to summarize discussions on EoE based on the 2016 Drug Development Conference sponsored by the Center for Diagnostics and Therapeutics of the American Gastroenterological Association.

Landercasper, J., L. Bailey, R. Buras, E. Clifford, A. C. Degnim, L. Thanasoulis, O. M. Fayanju, J. A. Tjoe and R. Rao (2017). “The american society of breast surgeons and quality payment programs: Ranking, defining, and benchmarking more than 1 million patient quality measure encounters.” Ann Surg Oncol: 2017 Aug [Epub ahead of print].

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BACKGROUND: To identify and remediate gaps in the quality of surgical care, the American Society of Breast Surgeons (ASBrS) developed surgeon-specific quality measures (QMs), built a patient registry, and nominated itself to become a Center for Medicare and Medicaid Services (CMS) Qualified Clinical Data Registry (QCDR), thereby linking surgical performance to potential reimbursement and public reporting. This report provides a summary of the program development. METHODS: Using a modified Delphi process, more than 100 measures of care quality were ranked. In compliance with CMS rules, selected QMs were specified with inclusion, exclusion, and exception criteria, then incorporated into an electronic patient registry. After surgeons entered QM data into the registry, the ASBrS provided real-time peer performance comparisons. RESULTS: After ranking, 9 of 144 measures of quality were chosen, submitted, and subsequently accepted by CMS as a QCDR in 2014. The measures selected were diagnosis of cancer by needle biopsy, surgical-site infection, mastectomy reoperation rate, and appropriateness of specimen imaging, intraoperative specimen orientation, sentinel node use, hereditary assessment, antibiotic choice, and antibiotic duration. More than 1 million patient-measure encounters were captured from 2010 to 2015. Benchmarking functionality with peer performance comparison was successful. In 2016, the ASBrS provided public transparency on its website for the 2015 performance reported by our surgeon participants. CONCLUSIONS: In an effort to improve quality of care and to participate in CMS quality payment programs, the ASBrS defined QMs, tracked compliance, provided benchmarking, and reported breast-specific QMs to the public.

Konda, V. J. A. (2017). “Computer-aided diagnosis: Further eliminating the human factor in endoscopy?” Endoscopy 49(8): 734-735.

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Advanced imaging modalities in endoscopy provide visualization of the tissue in greater detail than what can be obtained by gross visualization through white-light endoscopy. Magnifying chromoendoscopy, digital chromoendoscopy with magnification, confocal laser endomicroscopy, and ultra-high endocytoscopy provide images that enhance mucosal, vascular, or even cellular visualization. Advanced imaging technologies provide an image, but that image is only useful if it can be correctly interpreted in a clinically meaningful way. In the colon, advanced imaging has the potential to improve a range of clinical outcomes. For example, the use of narrowband imaging may be used to diagnose diminutive colon polyps, and meets thresholds to consider a resect and discard strategy to minimize cost, time, and risk [1]. On the other end of the spectrum, advanced imaging with endocytoscopy may provide information to determine which lesions are amenable to endoscopic resection by providing a real-time method to diagnose invasive cancer [2].