Effect of optical diagnosis training on recognition and treatment of submucosal invasive colorectal cancer in community hospitals: a prospective multicenter intervention study.

BACKGROUND: Recognition of submucosal invasive colorectal cancer (T1 CRC) is difficult, with sensitivities of 35 %-60 % in Western countries. We evaluated the real-life effects of training in the OPTICAL model, a recently developed structured and validated prediction model, in Dutch community hospitals. METHODS: In this prospective multicenter study (OPTICAL II), 383 endoscopists from 40 hospitals were invited to follow an e-learning program on the OPTICAL model, to increase sensitivity in detecting T1 CRC in nonpedunculated polyps. Real-life recognition of T1 CRC was then evaluated in 25 hospitals. Endoscopic and pathologic reports of T1 CRCs detected during the next year were collected retrospectively, with endoscopists unaware of this evaluation. Sensitivity for T1 CRC recognition, R0 resection rate, and treatment modality were compared for trained vs. untrained endoscopists. RESULTS: 1 year after e-learning, 528 nonpedunculated T1 CRCs were recorded for endoscopies performed by 251 endoscopists (118 [47 %] trained). Median T1 CRC size was 20 mm. Lesions were mainly located in the distal colorectum (66 %). Trained endoscopists recognized T1 CRCs more frequently than untrained endoscopists (sensitivity 74 % vs. 62 %; mixed model analysis odds ratio [OR] 2.90, 95 %CI 1.54-5.45). R0 resection rate was higher for T1 CRCs detected by trained endoscopists (69 % vs. 56 %; OR 1.73, 95 %CI 1.03-2.91). CONCLUSION: Training in optical recognition of T1 CRCs in community hospitals was associated with increased recognition of T1 CRCs, leading to higher en bloc and R0 resection rates. This may be an important step toward more organ-preserving strategies.

Standardised training for endoscopic mucosal resection of large non-pedunculated colorectal polyps to reduce recurrence (*STAR-LNPCP study): a multicentre cluster randomised trial.

OBJECTIVE: Endoscopic mucosal resection (EMR) is the preferred treatment for non-invasive large (≥20 mm) non-pedunculated colorectal polyps (LNPCPs) but is associated with an early recurrence rate of up to 30%. We evaluated whether standardised EMR training could reduce recurrence rates in Dutch community hospitals. DESIGN: In this multicentre cluster randomised trial, 59 endoscopists from 30 hospitals were randomly assigned to the intervention group (e-learning and 2-day training including hands-on session) or control group. From April 2019 to August 2021, all consecutive EMR-treated LNPCPs were included. Primary endpoint was recurrence rate after 6 months. RESULTS: A total of 1412 LNPCPs were included; 699 in the intervention group and 713 in the control group (median size 30 mm vs 30 mm, 45% vs 52% size, morphology, site and access (SMSA) score IV, 64% vs 64% proximal location). Recurrence rates were lower in the intervention group compared with controls (13% vs 25%, OR 0.43; 95% CI 0.23 to 0.78; p=0.005) with similar complication rates (8% vs 9%, OR 0.93; 95% CI 0.64 to 1.36; p=0.720). Recurrences were more often unifocal in the intervention group (92% vs 76%; p=0.006). In sensitivity analysis, the benefit of the intervention on recurrence rate was only observed in the 20-40 mm LNPCPs (5% vs 20% in 20-29 mm, p=0.001; 10% vs 21% in 30-39 mm, p=0.013) but less evident in ≥40 mm LNPCPs (24% vs 31%; p=0.151). In a post hoc analysis, the training effect was maintained in the study group, while in the control group the recurrence rate remained high. CONCLUSION: A compact standardised EMR training for LNPCPs significantly reduced recurrences in community hospitals. This strongly argues for a national dedicated training programme for endoscopists performing EMR of ≥20 mm LNPCPs. Interestingly, in sensitivity analysis, this benefit was limited for LNPCPs ≥40 mm. TRIAL REGISTRATION NUMBER: NTR7477.

Gastrointestinal symptoms in patients with isolated oligodontia and a Wnt gene mutation.

OBJECTIVE: Since Wnt signaling plays an important role in both tooth agenesis and altered intestine homeostasis, the aim was to compare gastrointestinal symptoms in patients with isolated oligodontia caused by a Wnt pathway gene mutation and controls. METHODS: A case-control study was designed to compare self-reported gastrointestinal symptoms among patients with isolated oligodontia, caused by a Wnt signaling gene mutation, and fully dentate controls. The Gastrointestinal Symptom Rating Scale (GSRS) was used to assess gastrointestinal symptoms. Prevalence and severity of gastrointestinal symptoms among patients and age- and gender-matched controls were evaluated. RESULTS: Twenty patients with isolated oligodontia and a pathogenic variant in the wnt pathway genes WNT10A, LRP6, or PAX9 participated. The prevalence of gastrointestinal symptoms was higher in the oligodontia patients compared to their controls (Χ2 (1) = 87.33, p = .008). Mean GSRS total scores (p = .011) and domain scores for "abdominal pain" (p = .022), "reflux" (p = .003) and constipation (p = .030) were higher for these oligodontia patients compared to their controls. CONCLUSION: Gastrointestinal symptoms are more prevalent and more severe in patients with isolated oligodontia and a deficiency in a Wnt pathway-related gene, when compared to controls without tooth agenesis.

Safety of low-volume PEG-asc bowel cleansing preparation for colonoscopy: identifying patients at risk for hypokalemia in a prospective cohort study.

Background and study aims The aim of bowel cleansing preparation should be high-quality results and conformance with safety standards. Previously, we reported that hypokalemia occurred in 23.6 % of patients after bowel preparation in a high-risk population on diuretics or hospitalized and referred for colonoscopy. Here we report on a prospective study in a non-selected colonoscopy cohort to identify patients at risk of developing hypokalemia before and after bowel cleansing with low-volume polyethylene glycol with ascorbic acid (PEG-asc). Patients and methods From January 1 to July 31, 2016, we included all patients undergoing colonoscopy in our institution. Prevalences of hypokalemia before and after PEG-asc bowel cleansing for colonoscopy were calculated and risk factors for developing hypokalemia after PEG-asc bowel cleansing were identified. Results In total, 2011 patients were included in the analysis. Of these, 0.8 % had hypokalemia before bowel cleansing with PEG-asc. After bowel preparation, 5.4 % developed hypokalemia. Of the patients, 281 were considered to have "high cardiac risk." The combination of "high cardiac risk" and hypokalemia was present in 1 % of the initial colonoscopy population. Female sex, colorectal cancer diagnosis, and thiazide use were found to be significant predictors for hypokalemia after use of PEG-asc. No arrhythmias or serious adverse events due to hypokalemia occurred. Conclusions Physicians referring patients for colonoscopy should be aware that "high cardiac risk" patients and those on thiazide diuretics undergoing bowel cleansing for colonoscopy are a risk of developing post-cleansing hypokalemia but it remains to be determined whether their risk of developing life-threatening arrhythmias is truly increased.

Evaluation of polypectomy quality indicators of large nonpedunculated colorectal polyps in a nonexpert, bowel cancer screening cohort.

BACKGROUND AND AIMS: With the introduction of the national bowel cancer screening program, the detection of sessile and flat colonic lesions ≥20 mm in size, defined as large nonpedunculated colorectal polyps (LNPCPs), has increased. The aim of this study was to examine the quality of endoscopic treatment of LNPCPs in the Dutch screening program. METHODS: This investigation comprised 2 related, but separate, substudies (1 with a cross-sectional design and 1 with a longitudinal design). The first examined prevalence and characteristics of LNPCPs in data from the national Dutch screening cohort from February 2014 until January 2017. The second, with screening data from 5 endoscopy units in the Southern part of the Netherlands from February 2014 until August 2015, examined performance on important quality indicators (technical and clinical successes, recurrence rate, adverse event rate, and surgery referral rate). All patients were part of the national Dutch screening cohort. RESULTS: In the national cohort, an LNPCP was detected in 8% of participants. Technical and clinical success decreased with increasing LNPCP size, from 93% and 96% in 20- to 29-mm lesions to 85% and 86% in 30- to 39-mm lesions and to 74% and 81% in ≥40-mm lesions (P < .001; P = .034). The cumulative recurrence rate at 12 months increased with LNPCP size, from 9% to 22% and 26% in the respective size groups (P = .095). The adverse event rate was 5%. The overall surgical referral rate for noninvasive LNPCPs was 7%. CONCLUSIONS: In this performance of 2 substudies, it was shown that quality parameters for endoscopic resection of large polyps in the Dutch screening cohort are not reached, especially in ≥30-mm polyps. Endoscopic resection of large polyps could benefit from additional training, quality monitoring, and centralization either within or between centers.

Retrieval and re-evaluation of previously diagnosed chronic hepatitis C infections lost to medical follow-up in the Netherlands.

OBJECTIVES: Many individuals previously diagnosed with chronic hepatitis C virus (HCV) infection are likely to be lost to medical follow-up and, therefore, remain untreated despite new highly effective drug treatment, direct acting antivirals. We aim to identify and retrieve these chronic HCV-infected individuals to re-evaluate them and offer treatment. METHODS: Possible chronic HCV infections were identified from test results of the medical microbiological laboratory, notifications to the public health service, and the hospital registries over the past 15 years were checked in South Limburg, the Netherlands. Individuals were contacted based on the physician-patient relationship of the gastroenterologist or microbiologist (retrieval). Individuals were informed about the new treatment options, offered an HCV-RNA test, and if still positive, referred to the gastroenterologist for treatment (re-evaluation). RESULTS: In total, 689 individuals with a positive anti-HCV test in the past were identified, 308 (45%) were eligible for retrieval, 90 (29%) of them were retrieved, 34 (38%) of those retrieved were re-evaluated, 19 (56%) of those tested were HCV-RNA positive, and 12 (63%) of these individuals were offered treatment. CONCLUSION: During every step of the retrieval chain, many patients were lost. Nevertheless, with substantial effort, we were able to identify, retrieve, and positively re-evaluate a limited number of individuals with a possible chronic HCV infection who were lost to medical follow-up (19 patients). With this case-finding approach, we were able to prevent potential severe complications in these patients and contribute to a small step in the eradication of HCV in the Netherlands.

Temporal trends and variability of colonoscopy performance in a gastroenterology practice.

BACKGROUND AND STUDY AIM: Quality measures for colonoscopy are operator dependent and vary. It is unclear whether quality measures change over time. In this study, time-dependent variation in colonoscopy performance was examined in a gastroenterology practice. PATIENTS AND METHODS: Colonoscopy and histopathology records that were collected at three hospitals (one university and two non-university hospitals) over three time periods (2007, 2010, and 2013) were reviewed. Data from colonoscopists performing at least 100 procedures per year were analyzed. Inter-colonoscopist variation in performance (i. e. adjusted cecal intubation rate [aCIR], adenoma detection rate [ADR], advanced ADR, mean adenomas per procedure [MAP], proximal ADR, nonpolypoid ADR, and serrated polyp detection rate) were examined using coefficients of variation. Logistic regression analyses were also performed, adjusting for covariates. RESULTS: A total of 23 colonoscopists performing 6400 procedures were included. Overall, the mean aCIR, ADR, MAP, and proximal ADR improved significantly over time, from 91.9 %, 22.5 %, 0.37, and 10.2 % in 2007 to 95.3 %, 25.8 %, 0.45, and 13.4 %, respectively, in 2013 (P < 0.05). The inter-colonoscopist variation in ADR decreased from 37 % in 2007 to 15 % in 2013 (P < 0.05). In the non-university hospitals, mean values for quality measures increased significantly over time, whereas they remained stable in the university hospital. CONCLUSIONS: Variability in performance among colonoscopists decreased significantly within the gastroenterology clinical practice. Core quality measures improved over time, mainly through improvement of the lower performers. Measurement of inter-colonoscopist variation in performance helps to identify factors that stimulate or hinder performance, and forms the basis for interventions. TRIAL REGISTRATION: http://www.trialregister.nl.

The ACCURE-trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicenter trial (NTR2883) and the ACCURE-UK trial: a randomised external pilot trial (ISRCTN56523019).

BACKGROUND: Over the past 20 years evidence has accumulated confirming the immunomodulatory role of the appendix in ulcerative colitis (UC). This led to the idea that appendectomy might alter the clinical course of established UC. The objective of this body of research is to evaluate the short-term and medium-term efficacy of appendectomy to maintain remission in patients with UC, and to establish the acceptability and cost-effectiveness of the intervention compared to standard treatment. METHODS/DESIGN: These paired phase III multicenter prospective randomised studies will include patients over 18 years of age with an established diagnosis of ulcerative colitis and a disease relapse within 12 months prior to randomisation. Patients need to have been medically treated until complete clinical (Mayo score <3) and endoscopic (Mayo score 0 or 1) remission. Patients will then be randomised 1:1 to a control group (maintenance 5-ASA treatment, no appendectomy) or elective laparoscopic appendectomy plus maintenance treatment. The primary outcome measure is the one year cumulative UC relapse rate - defined both clinically and endoscopically as a total Mayo-score ≥5 with endoscopic subscore of 2 or 3. Secondary outcomes that will be assessed include the number of relapses per patient at 12 months, the time to first relapse, health related quality of life and treatment costs, and number of colectomies in each arm. DISCUSSION: The ACCURE and ACCURE-UK trials will provide evidence on the role and acceptability of appendectomy in the treatment of ulcerative colitis and the effects of appendectomy on the disease course. TRIAL REGISTRATION: NTR2883 ; ISRCTN56523019.