Ergonomic endoscopy: An oxymoron or realistic goal?

The current endoscope design is not ergonomic. There is a high prevalence of endoscopy-related injury reported in the literature, and studies have demonstrated high-risk biomechanical exposures during the performance of routine colonoscopy. Endoscopy ergonomics focuses on understanding the endoscopist's interaction with the endoscope and the endoscopy unit and re-designing these tasks to minimize the risk of endoscopy-related injury. The discussion to date has focused on what the endoscopist can do to minimize his or her risk of injury. It is imperative that we re-frame that discussion because the implication that physicians are responsible for implementing personal or workplace interventions places an undue burden on physicians and will be the least effective exposure control method. Endoscope companies need to consider the endoscopist in their design process. As a profession, we need to collectively advocate for endoscopist safety. We offer a perspective on how ergonomic endoscopy can become a realistic and achievable goal.

Optimizing the quality of endoscopy in inflammatory bowel disease: focus on surveillance and management of colorectal dysplasia using interactive image- and video-based teaching.

BACKGROUND AND AIMS: Varying recommendations regarding the detection and management of dysplasia can lead to uncertainty and may impede the uptake of strategies that could improve surveillance in patients with inflammatory bowel disease (IBD). An educational event was held to assist in disseminating the recently published Surveillance for Colorectal Endoscopic Neoplasia Detection and Management in Inflammatory Bowel Disease Patients: International Consensus Recommendations (SCENIC). METHODS: Specialists in IBD and endoscopy led the Optimizing Quality of Endoscopy in IBD course. The American Society for Gastrointestinal Endoscopy (ASGE) organized the course, and the Crohn's and Colitis Foundation of America (CCFA) provided endorsement. One was held in March 2015 at the ASGE Institute for Training and Technology in Chicago, Illinois, and the second in September 2016 preceding the ASGE Endofest in Chandler, Arizona. The program included interactive case-based discussions and didactic presentations on topics including the rationale and current approach of surveillance in IBD; endoscopic characterization and nomenclature of active and quiescent disease; detection of dysplasia during IBD surveillance; role of image-enhanced endoscopy in IBD surveillance, with a focus on chromoendoscopy technique; and management of dysplasia in IBD. Participants were surveyed before and after the course to assess their perspectives and practice. RESULTS: Eighteen presenters or panel members and approximately 92 IBD and endoscopist physician leaders attended the meeting. Most attendees were aged 30 to 49 years (88.1%), had been in practice less than 10 years (89.7%), were from academic medical centers (90.7%), and spent >50% of their time caring for patients with IBD (59.7%). Recommended quality improvements for endoscopy in IBD included the use of endoscopic scoring systems to describe disease activity, the use of a modified Paris classification to characterize visible dysplastic lesions (polypoid, nonpolypoid with description of presence of ulcer and distinct or indistinct borders), the use of chromoendoscopy for dysplasia detection, and the endoscopic removal of visible dysplastic lesions. In the follow-up survey, participants were asked to indicate whether they had changed their practice as a result of attending the course. Ninety-three percent (93%) indicated they had changed their practice. For dysplasia detection, the use of chromoendoscopy increased: 51.7% of respondents reported using chromoendoscopy in most surveillance colonoscopies compared with 34.3% before the course. For dysplasia management, the use of EMR increased for polypoid and nonpolypoid lesions 10 to 20 mm in size; and the referral of dysplastic lesions 20 mm or larger that appeared endoscopically resectable shifted toward removal by an experienced endoscopist. CONCLUSIONS: Evidence-based advances in endoscopy have occurred in the characterization and nomenclature of active and quiescent disease, polypoid and nonpolypoid dysplasia in IBD, and in the detection and management of dysplasia in colonic IBD. Implementation of updated guidelines and recommendations into clinical practice may be facilitated by interactive image- and video-based courses on the topic.

Paradigm Shift in the Surveillance and Management of Dysplasia in Inflammatory Bowel Disease (West).

Patients with long-standing inflammatory bowel disease (IBD) colitis have a 2.4-fold higher risk of developing colorectal cancer (CRC) than the general population, for both ulcerative colitis (UC) and Crohn's disease (CD) colitis. Surveillance colonoscopy is recommended to detect early CRC and dysplasia. Most dysplasia discovered in patients with IBD is actually visible. Recently published SCENIC (Surveillance for Colorectal Endoscopic Neoplasia Detection and Management in Inflammatory Bowel Disease Patients: International Consensus Recommendations) consensus statements provide unifying recommendations for the optimal surveillance and management of dysplasia in IBD. SCENIC followed the prescribed processes for guideline development from the Institute of Medicine (USA), including systematic reviews, full synthesis of evidence and deliberations by panelists, and incorporation of the GRADE methodology. The new surveillance paradigm involves high-quality visual inspection of the mucosa, using chromoendoscopy and high-definition colonoscopy, with endoscopic recognition of colorectal dysplasia. Lesions are described according to a new classification, which replaces the term 'dysplasia associated lesion or mass (DALM)' and its derivatives. Targeted biopsies are subsequently done on areas suspicious for dysplasia, and resections are carried out for discrete, resectable lesions.

Real-time optical diagnosis for diminutive colorectal polyps using narrow-band imaging: the VALID randomised clinical trial.

BACKGROUND: Diminutive (≤ 5 mm) colorectal polyps are common, and overwhelmingly benign. Routinely, after polypectomy, they are examined pathologically to determine the surveillance intervals. Advances in equipment and techniques, such as narrow-band imaging (NBI) colonoscopy, now permit reliable real-time optical diagnosis. METHODS: We conducted a randomised single-masked study involving three institutions to determine whether optical diagnosis of diminutive colorectal polyps meets clinical practice standards and reduces the need for histopathology. We randomly assigned eligible patients undergoing routine high-definition colonoscopy to optical diagnosis using near focus versus standard view, using computer-generated block sequence. By validated criteria, we rendered an optical diagnosis and a confidence level (high vs low) for all polyps, using NBI. Our primary endpoint was the number of accurate high-confidence optical diagnoses compared with central blinded pathology in the two groups. We analysed data using intention to treat. FINDINGS: We enrolled 558 subjects, and randomly assigned 281 to near focus and 277 to standard view optical diagnosis. We detected 1309 predominantly diminutive (74.5%) and neoplastic (60.0%) polyps. Endoscopists were significantly more likely, OR 2.2 (95% CI 1.6 to 3.0, p<0.0001), to make a high-confidence optical diagnosis with near focus (85.1%) than standard (72.6%) view. High-confidence diagnoses had 96.4% and 92.0% negative predictive value, respectively. Of all polyps, 75.3% (95% CI71.3% to 78.9%) had a high-confidence accurate prediction using near focus, compared with 63.1% (95% CI 58.5% to 67.6%) using standard view. Optical versus histopathological diagnosis showed excellent agreement between the surveillance intervals, 93.5% in near focus and 92.2% in standard view. The median diagnosis time was 14 s. CONCLUSIONS: Real-time optical diagnosis using NBI colonoscopy may replace the pathology diagnosis for the majority of diminutive colorectal polyps. Using colonoscopy with near focus view increases the confidence level of the optical diagnosis. Optical diagnosis would be a paradigm shift in clinical practice of colonoscopy for colorectal cancer screening. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT01288833.

Protective association of colonoscopy against proximal and distal colon cancer and patterns in interval cancer.

BACKGROUND: The protective effect of colonoscopy against proximal colorectal cancer is variable and depends on the detection and complete removal of precancerous polyps. OBJECTIVE: To estimate the efficacy of colonoscopy in a medical center with open-access screening colonoscopy since 1998. DESIGN: Nested case-control study with incidence density sampling. SETTING: University-affiliated Veterans Affairs Medical Center. PATIENTS: Colorectal cancer (CRC) cases and control subjects selected from screening age patients matched by age, gender, and date of first primary care visit. MAIN OUTCOME MEASUREMENT: Colonoscopy preceding the CRC diagnosis date. RESULTS: A total of 20.2% of CRC cases had a colonoscopy in the preceding 10 years compared with 49.0% of control subjects (adjusted odds ratio [aOR], 0.20; 95% confidence interval [CI], 0.11-0.34). Colonoscopy was strongly associated with decreased odds of both distal CRC (aOR, 0.16; 95% CI, 0.07-0.34) and proximal CRC (aOR, 0.26; 95% CI, 0.11-0.58). The fraction of cases attributed to interval cancers was 10.5%. Missed lesions predominantly localized to the cecum and rectum, and recurrent lesions clustered in the hepatic flexure. Cecal intubation rate was 93% (98% in adequately prepped patients), and the adenoma detection rate was 45.2% in the control group. LIMITATIONS: Single-center, retrospective case-control design. CONCLUSION: In an open access colonoscopy program characterized by a high cecal intubation rate and adenoma detection rate, colonoscopy was strongly associated with reduced odds of both distal and proximal CRC. Among interval cancers, missed lesions clustered in the cecum and rectum and recurrent lesions in the hepatic flexure.

Randomized trial of standard versus magnetic endoscope imaging colonoscopes for unsedated colonoscopy.

BACKGROUND: Unsedated colonoscopy has potential benefits, including decreased costs and decreased risks. OBJECTIVE: To determine whether patient comfort during unsedated colonoscopy can be improved through the use of a magnetic endoscopic imaging (MEI) colonoscope compared with a standard colonoscope. DESIGN: Prospective, patient-blinded, randomized, controlled trial. SETTING: San Francisco Veterans Affairs Medical Center. PATIENTS: Veterans undergoing outpatient screening or surveillance colonoscopy. INTERVENTIONS: Use of a standard or MEI colonoscope during unsedated colonoscopy. MAIN OUTCOME MEASUREMENT: The primary outcome variable was patient perception of pain using a 7-point scale. The secondary endpoint was patient willingness to undergo a future unsedated colonoscopy. RESULTS: Of the 160 patients enrolled, 140 completed an unsedated colonoscopy in the study protocol. In a per-protocol analysis, the mean and median pain score was 3.12 (standard deviation 1.22) and 4 (interquartile range 2-4) for the standard colonoscope group and 3.06 (standard deviation 1.13) and 3 (interquartile range 2-4) for the MEI group, where 3 was mild pain (P = not significant). Overall, 80% of subjects were willing to undergo a future unsedated colonoscopy for screening or surveillance. In an intention-to-treat analysis, 80% of subjects (64/80) in the standard colonoscope arm and 79% in the MEI arm (63/80) were willing to undergo a future unsedated colonoscopy (P = not significant). LIMITATIONS: Single-center study of mostly male veterans. CONCLUSIONS: This patient-blinded, randomized, controlled trial did not demonstrate any difference in patient perception of pain or willingness to undergo unsedated examinations when using the MEI versus the conventional colonoscope. Unsedated colonoscopy is generally feasible and well tolerated and is associated with high patient satisfaction rates.

Reduced cathartic bowel preparation for CT colonography: prospective comparison of 2-L polyethylene glycol and magnesium citrate.

PURPOSE: To prospectively compare adequacy of colonic cleansing, adequacy of solid stool and fluid tagging, and patient acceptance by using reduced-volume, 2-L polyethylene glycol (PEG) versus magnesium citrate bowel preparations for CT colonography. MATERIALS AND METHODS: This study was approved by the institutional Committee on Human Research and was compliant with HIPAA; all patients provided written consent. In this randomized, investigator-blinded study, 50 patients underwent oral preparation with either a 2-L PEG or a magnesium citrate solution, tagging with oral contrast agents, and subsequent CT colonography and segmentally unblinded colonoscopy. The residual stool (score 0 [best] to 3 [worst]) and fluid (score 0 [best] to 4 [worst]) burden and tagging adequacy were qualitatively assessed. Residual fluid attenuation was recorded as a quantitative measure of tagging adequacy. Patients completed a tolerance questionnaire within 2 weeks of scanning. Preparations were compared for residual stool and fluid by using generalized estimating equations; the Mann-Whitney test was used to compare the qualitative tagging score, mean residual fluid attenuation, and adverse effects assessed on the patient experience questionnaire. RESULTS: The mean residual stool (0.90 of three) and fluid burden (1.05 of four) scores for PEG were similar to those for magnesium citrate (0.96 [P = .58] and 0.98 [P = .48], respectively). However, the mean fecal and fluid tagging scores were significantly better for PEG (0.48 and 0.28, respectively) than for magnesium citrate (1.52 [P < .01] and 1.28 [P < .01], respectively). Mean residual fluid attenuation was higher for PEG (765 HU) than for magnesium citrate (443 HU, P = .01), and mean interpretation time was shorter for PEG (14.8 minutes) than for magnesium citrate (18.0 minutes, P = .04). Tolerance ratings were not significantly different between preparations. CONCLUSION: Reduced-volume PEG and magnesium citrate bowel preparations demonstrated adequate cleansing effectiveness for CT colonography, with better tagging and shorter interpretation time observed in the PEG group. Adequate polyp detection was maintained but requires further validation because of the small number of clinically important polyps.

An explicit quality indicator set for measurement of quality of care in patients with cirrhosis.

BACKGROUND & AIMS: Cirrhosis is a prevalent and expensive condition. With an increasing emphasis on quality in health care and recognition of inconsistencies in the management of patients with cirrhosis, we established a set of explicit quality indicators (QIs) for their treatment. METHODS: We organized an 11-member, multidisciplinary expert panel and followed modified Delphi methods to systematically identify a set of QIs for cirrhosis. We provided the panel with a report that summarized the results of a comprehensive literature review of data linking candidate QIs to outcomes. The panel performed independent ratings of each candidate QI by using a standard 9-point RAND appropriateness scale (RAS) (ranging from 1 = not appropriate to 9 = most appropriate). The panel members then met, reviewed the ratings, and voted again by using an iterative process of discussion. The final set of QIs was selected; QIs had a median RAS >7, and panel members agreed on those selected. RESULTS: Among 169 candidate QIs, the panel rated 41 QIs as valid measures of quality care. The selected QIs cover 6 domains of care including ascites (13 QIs), variceal bleeding (18 QIs), hepatic encephalopathy (4 QIs), hepatocellular cancer (1 QI), liver transplantation (2 QIs), and general cirrhosis care (3 QIs). Content coverage included prevention, diagnosis, treatment, timeliness, and follow-up. CONCLUSIONS: We developed an explicit set of evidence-based QIs for treatment of cirrhosis. These provide physicians and institutions with a tool to identify processes amenable to quality improvement. This tool is intended to be applicable in any setting where care for patients with cirrhosis is provided.

Impact of observational training on endoscopic mucosal resection outcomes and competency for large colorectal polyps: single endoscopist experience.

Background and study aims Endoscopic mucosal resection (EMR) is standard treatment for large colorectal polyps. However, it is a specialized technique with limited data on the effectiveness of training methods to acquire this skill. The aim of this study was to evaluate the impact of observational training on EMR outcomes and competency in an early-stage endoscopist. Patients and methods A single endoscopist completed comprehensive EMR training, which included knowledge acquisition and direct observation of EMR cases, and proctored supervision, during the third year of gastroenterology fellowship. After training, EMR was independently attempted on 142 consecutive, large (i. e., ≥ 20 mm), non-pedunculated colorectal polyps between July 2014 and December 2017 (mean age 61.7 years; mean polyp size 30.4 mm; en-bloc resection 55 %). Surveillance colonoscopy for evaluation of residual neoplasia was available for 86 % of the cases. Three primary outcomes were evaluated: endoscopic assessment of complete resection, rate of adverse events (AEs), and rate of residual neoplasia on surveillance colonoscopy. Results Complete endoscopic resection was achieved in 93 % of cases, the rates of AEs and residual neoplasia were 7.8 % and 7.3 %, respectively. The rate of complete resection remained stable (at 85 % or greater) with increasing experience while rates of AEs and residual neoplasia peaked and decreased after 60 cases. Conclusions An early-stage endoscopist can acquire the skills to perform effective EMR after completing observational training. At least 60 independent EMRs for large colorectal polyps were required to achieve a plateau for clinically meaningful outcomes.

Endoscopic therapy for bleeding ulcers: an evidence-based approach based on meta-analyses of randomized controlled trials.

The aim of this study was to determine appropriate endoscopic treatment of patients with bleeding ulcers by synthesizing results of randomized controlled trials. We performed dual independent bibliographic database searches to identify randomized trials of thermal therapy, injection therapy, or clips for bleeding ulcers with active bleeding, visible vessels, or clots, focusing on results from studies without second-look endoscopy and re-treatment. The primary end point was further (persistent plus recurrent) bleeding. Compared with epinephrine, further bleeding was reduced significantly by other monotherapies (relative risk [RR], 0.58 [95% CI, 0.36-0.93]; number-needed-to-treat [NNT], 9 [95% CI, 5-53]), and epinephrine followed by another modality (RR, 0.34 [95% CI, 0.23-0.50]; NNT, 5 [95% CI, 5-7]); epinephrine was not significantly less effective in studies with second-look and re-treatment. Compared with no endoscopic therapy, further bleeding was reduced by thermal contact (heater probe, bipolar electrocoagulation) (RR, 0.44 [95% CI, 0.36-0.54]; NNT, 4 [95% CI, 3-5]) and sclerosant therapy (RR, 0.56 [95% CI, 0.38-0.83]; NNT, 5 [95% CI, 4-13]). Clips were more effective than epinephrine (RR, 0.22 [95% CI, 0.09-0.55]; NNT, 5 [95% CI, 4-9]), but not different than other therapies, although the latter studies were heterogeneous, showing better and worse results for clips. Endoscopic therapy was effective for active bleeding (RR, 0.29 [95% CI, 0.20-0.43]; NNT, 2 [95% CI, 2-2]) and a nonbleeding visible vessel (RR, 0.49; [95% CI, 0.40-0.59]; NNT, 5 [95% CI, 4-6]), but not for a clot. Bolus followed by continuous-infusion proton pump inhibitor after endoscopic therapy significantly improved outcome compared with placebo/no therapy (RR, 0.40 [95% CI, 0.28-0.59]; NNT, 12 [95% CI, 10-18]), but not compared with histamine(2)-receptor antagonists. Thermal devices, sclerosants, clips, and thrombin/fibrin glue appear to be effective endoscopic hemostatic therapies. Epinephrine should not be used alone. Endoscopic therapy should be performed for ulcers with active bleeding and nonbleeding visible vessels, but efficacy is uncertain for clots. Bolus followed by continuous-infusion intravenous proton pump inhibitor should be used after endoscopic therapy.

Pinch force and forearm-muscle load during routine colonoscopy: a pilot study.

BACKGROUND AND OBJECTIVE: Overuse injuries of the hand, wrist, forearm, and shoulder are common among endoscopists and may be from repetitive pinching and gripping forces or awkward posturing. In this pilot study, we evaluated distal upper-extremity musculoskeletal load during colonoscopy (1) to confirm the feasibility of performing ergonomic measurements in endoscopists and (2) to identify tasks that may contribute to overuse injuries. DESIGN AND SUBJECTS: Three experienced gastroenterologists were evaluated during 3 colonoscopies each. SETTING: Veterans Affairs Medical Center, San Francisco, California. MAIN OUTCOME MEASUREMENT: Right-thumb pinch force using a thumb-force sensor and bilateral forearm-muscle activity using electromyography. RESULTS: The mean duration of the 9 colonoscopies was 19.5 minutes. The highest mean (SD) right-thumb peak pinch forces occurred during left (10.4 [4.1] N) and right (10.1 [4.5] N) colon insertion, which exceeded the injury threshold of 10 N. Mean peak forearm-muscle activity was also greatest during left and right colon insertion. Activity of the left abductor pollicis longus, left extensor carpi radialis, and right extensor carpi radialis exceeded the American Conference of Industrial Hygienists (ACGIH) hand activity level (HAL) action limit. The left extensor carpi radialis was at the ACGIH HAL threshold limit. LIMITATIONS: The small sample size, no force measurement for the left thumb, and all the gastroenterologists were men. CONCLUSION: The pinch forces and forearm-muscle loads applied during routine colonoscopy may pose a risk for overuse injuries at the elbow and wrist.

Chemoprevention of colonic polyps with balsalazide: an exploratory, double-blind, placebo-controlled study.

BACKGROUND: A number of agents, including aspirin, nonsteroidal antiinflammatory drugs, cyclooxygenase-2 inhibitors, folic acid, calcium, and vitamins, have been evaluated for their potential in chemoprevention of sporadic colorectal adenomas or cancer. Preclinical data suggest that 5-aminosalicylates also may have a chemopreventive effect. AIM: To investigate chemoprevention of colonic polyps with balsalazide, a 5-aminosalicylate prodrug. METHODS: In this randomized, double-blind, placebo-controlled study, adults diagnosed with small polyps in the rectosigmoid colon were treated with either balsalazide 3 g/d or placebo for 6 months. Follow-up lower endoscopy was performed, and all polyps were measured and analyzed histologically. The primary endpoint was reduction in mean size of the largest polyp per subject. RESULTS: Among 241 participants screened, 86 were randomized to treatment, with 75 subjects evaluable. Balsalazide 3 g/d (n = 38) did not significantly reduce the mean size of the largest colonic polyp or the number of polyps compared with placebo (n = 37). Although not significant, post-hoc analysis revealed that total adenoma burden per subject, calculated as the sum of the volumes of all adenomas in mm3, increased by 55% in the balsalazide group compared with 95% in the placebo group. CONCLUSIONS: Although balsalazide did not have significant chemopreventive effects on established colonic polyps, these results can aid in designing future prospective studies.