Gastric dysplasia in random biopsies: the influence of Helicobacter pylori infection and alcohol consumption in the presence of a lesion.

BACKGROUND: Gastric dysplasia in the absence of an endoscopically defined lesion is rare, usually either a false positive diagnosis or a previously unidentified precancerous lesion during esophagogastroduodenoscopy (EGD). AIMS: Evaluate factors associated with the presence of an endoscopically visible lesion during follow-up in patients with histologic diagnosis of gastric dysplasia in random biopsies. METHODS: Retrospective cohort study including patients referred to our institution for gastric dysplasia in random biopsies during Index EGD. Endoscopic evaluation was performed with a high-definition endoscope using narrow band imaging (HD EGD-0). If no lesion was detected, endoscopic surveillance (HD EGD-FU) was conducted within 6 months for high grade dysplasia (HGD) or 12 months for low grade (LGD) or indefinite for dysplasia (IFD). RESULTS: From a total sample of 96 patients, 5 (5.2%) presented with an endoscopically visible lesion during HD EGD-0, while 10 lesions (10.4%) were identified during HD EGD-FU. Patients with Helicobacter pylori infection at Index EDG and with regular alcohol consumption (≥25 g/day) were 8 and 4 times more likely to have an endoscopically visible lesion on HD EGD-FU (p = 0.012 and p = 0.047). In binary logistic regression, both factors were independent predictors of the presence of gastric lesion on HD EGD-FU (OR 9.284, p = 0.009 and OR 5.025, p = 0.033). CONCLUSIONS: The presence of an endoscopically visible lesion after the histologic diagnosis of gastric dysplasia in random biopsies was more frequent during HD EGD-FU. H. pylori infection at Index EGD and regular alcohol consumption were significant predictors of the presence of gastric lesion on HD EGD-FU.

BEST-J Score: Validation of a Predicting Model for Delayed Bleeding After Gastric Endoscopic Submucosal Dissection on a European Sample.

BACKGROUND: Delayed bleeding (DB) is a possible adverse event following gastric endoscopic submucosal dissection (ESD). The BEST-J score was created as a risk prediction model for DB following gastric ESD, but is yet to be validated in Western populations. AIMS: We aimed to validate the BEST-J score on a European sample and to perform a subgroup analysis according to histological classification. METHODS: Retrospective study of all consecutive patients undergoing gastric ESD on a European Endoscopic Unit. DB was defined as hemorrhage with clinical symptoms and confirmed by emergency endoscopy from the time of completion to 28 days after ESD. BEST-J score was calculated in each patient and confronted with the outcome (DB). RESULTS: Final sample included 161 patients. From these, 10 (6.2%) presented DB following ESD, with a median time to bleeding of 7 days (IQR 6.8). BEST-J score presented an excellent accuracy predicting DB in our sample, with an AUC = 0.907 (95%CI 0.801-1.000; p < 0.001). Subgroup analysis by histological classification proved that the discriminative power was still excellent for each grade: low-grade dysplasia-AUC = 0.970 (p < 0.001); high-grade dysplasia-AUC = 0.874 (p < 0.001); early gastric cancer-AUC = 0.881 (p < 0.001). The optimal cut-off value to predict DB was a BEST-J score ≥ 3, which matches the cut-off value for high-risk of bleeding in the original investigation. CONCLUSIONS: The BEST-J score still presents excellent accuracy in risk stratification for post-ESD bleeding in European individuals. Thus, this score may help to guide which patients benefit the most from prophylactic therapies following gastric ESD in this setting.

Predicting residual neoplasia after a non-curative gastric ESD: validation and modification of the eCura system in the Western setting: the W-eCura score.

OBJECTIVE: To evaluate the risk factors for lymph node metastasis (LNM) after a non-curative (NC) gastric endoscopic submucosal dissection (ESD) and to validate and eventually refine the eCura scoring system in the Western setting. Also, to assess the rate and risk factors for parietal residual disease. DESIGN: Retrospective multicentre multinational study of prospectively collected registries from 19 Western centres. Patients who had been submitted to surgery or had at least one follow-up endoscopy were included. The eCura system was applied to assess its accuracy in the Western setting, and a modified version was created according to the results (W-eCura score). The discriminative capacities of the eCura and W-eCura scores to predict LNM were assessed and compared. RESULTS: A total of 314 NC gastric ESDs were analysed (72% high-risk resection (HRR); 28% local-risk resection). Among HRR patients submitted to surgery, 25% had parietal disease and 15% had LNM in the surgical specimen. The risk of LNM was significantly different across the eCura groups (areas under the receiver operating characteristic curve (AUC-ROC) of 0.900 (95% CI 0.852 to 0.949)). The AUC-ROC of the W-eCura for LNM (0.916, 95% CI 0.870 to 0.961; p=0.012) was significantly higher compared with the original eCura. Positive vertical margin, lymphatic invasion and younger age were associated with a higher risk of parietal residual lesion in the surgical specimen. CONCLUSION: The eCura scoring system may be applied in Western countries to stratify the risk of LNM after a gastric HRR. A new score is proposed that may further decrease the number of unnecessary surgeries.

A "new" option in Helicobacter pylori eradication: High-dose amoxicillin dual therapy outperforms bismuth quadruple therapy in a high dual resistance setting.

BACKGROUND: Currently, bismuth quadruple therapy (BQT) is indicated as a first-line treatment for Helicobacter pylori eradication in areas with high dual metronidazole and clarithromycin resistance, with its use being limited by its low tolerability and significant cost. A novel regimen with high-dose amoxicillin dual therapy (HDADT) has emerged as an alternative. The aim of this study was to compare the results of these two treatments on HP eradication. MATERIALS AND METHODS: Prospective randomized study including 100 consecutive patients undergoing H. pylori eradication. Each patient was randomized (in a 1:1 ratio) to one group of treatment: BQT (bismuth 140 mg + metronidazole 125 mg + tetracycline 125 mg, four times a day, for 10 days) or HDADT (amoxicillin 1000 mg alternating with amoxicillin 500 mg, four times a day, for 14 days), both associated with esomeprazole 40 mg twice a day. The primary aim was to compare treatments' efficacies. Secondary aims were to assess symptoms persistence and tolerability. RESULTS: A total of 100 patients were included, 54% women, with a mean age of 55 ± 14 years. From these, five were lost to follow-up. Effective eradication proven by negative stool antigen test was significantly higher in patients randomized to HDADT when compared to BQT for both intention-to-treat (ITT) (96.2% vs. 81.4%; p = .022) and per-protocol (PP) (95.9% vs. 81%; p = .025) analysis. These differences were even more pronounced when only considering second line treatment (100% vs. 62.5%; p = .028). Side effects did not differ significantly between BQT and HDADT groups for both ITT (7.0% vs. 2.0%; p = .254) and PP (4.8% vs. 0%; p = .210) analysis. CONCLUSIONS: When compared to BQT, treatment with HDADT presented higher and near 100% efficacy in eradicating H. pylori, without differences in reported side effects or compliance. This treatment represents an important alternative for populations with increasing incidences of resistance to the currently recommended antibiotic regimens.

Real-life patency of plastic biliary stents in the pandemic era: is stent removal after 6 months safe and effective?

BACKGROUND: The SARS-CoV-2 pandemic conditioned the optimal timing of some endoscopic procedures. ESGE guidelines recommend replacement or removal of the plastic biliary stents within 3-6 months to reduce the risk of complications. Our aim was to analyse the outcomes of patients who had delayed plastic biliary stent removal following endoscopic retrograde cholangiopancreatography (ERCP) in the pandemic era. METHODS: Retrospective study including consecutive ERCPs with plastic biliary stent placement between January 2019 and December 2021. Delayed removal was defined as presence of biliary stent >6 months after ERCP. The evaluated outcomes were stent migration, stent dysfunction, obstructive jaundice, cholangitis, acute pancreatitis, hospitalization, and biliary pathology-related mortality. RESULTS: One-hundred and twenty ERCPs were included, 56.7% male patients, with a mean age of 69.4 ± 15.7 years. Indications for plastic biliary stent insertion were choledocholithiasis (72.5%), benign biliary stricture (20.0%), and post-cholecystectomy fistula (7.5%). Delayed stent removal occurred in 32.5% of the cases. The median time to stent removal was 3.5 ± 1.3 months for early removal and 8.6 ± 3.1 months for delayed removal. Patients who had delayed stent removal did not have a significantly higher frequency of stent migration (20.5 vs 11.1%, p = 0.17), stent dysfunction (17.9 vs 13.6%, p = 0.53), hospitalization (17.9 vs 14.8%, p = 0.66), obstructive jaundice (2.6 vs 0.0%, p = 0.33), cholangitis (10.3 vs 13.6%, p = 0.77), acute pancreatitis (0.0 vs 1.2%, p = 1.0), or biliary pathology-related mortality (2.6 vs 1.2%, p = 0.55). CONCLUSIONS: Delayed plastic biliary stent removal does not seem to have a negative impact on patients' outcomes. In the current pandemic situation, while scheduled endoscopic procedures may have to be postponed, elective removal of plastic biliary stents can be safely deferred.

Gastrostomy Button Diameter and Length Variations after Percutaneous Endoscopic Gastrostomy: One Size Does Not Fit All.

BACKGROUND: Percutaneous endoscopic gastrostomy (PEG) is a useful option for long-term enteral nutrition. Low-profile gastrostomy tubes ("buttons") may afterward be placed in the stomach through the abdominal wall following maturation of the preexisting ostomy. Regular verification is essential since inadequate sizing is associated with accidental exteriorization or food leakage. We aimed to evaluate gastrostomy buttons diameter or length variations on the first year after their placement and possible factors associated with these variations. METHODS: We analyzed consecutive PEGs between 2016 and 2018. A minimum follow-up of 12 after gastrostomy button placement was required. Diameter or length variations were assessed in a specialized PEG appointment during the follow-up period. RESULTS: Final sample included 94 patients, from which 65 (69.1%) were women, and 29 (30.9%) were men, with a mean age of 76.9 ± 13.3 years. Measurements variations occurred in 44 (46.8%) patients. Diameter variation was significantly more frequent in patients living in a nursing home (OR = 5.43; 95% CI = 1.32-22.27; p = 0.019), patients with previous PEG tube dislodgement (OR = 3.84; 95% CI = 1.21-12.20; p = 0.023), and male patients (OR = 3.50; 95% CI = 1.06-11.49, p = 0.039). Length variation occurred more frequently in patients with a weight change during the follow-up period greater than 5 kg (OR = 3.71; 95% CI = 1.14-12.05; p = 0.029). CONCLUSIONS: A significant proportion of patients with gastrostomy buttons required a change in their measurements, especially if male, living in nursing homes, having significant weight changes, or accidental tube exteriorization. This emphasizes the importance of having a specialized PEG appointment to regularly assure the best fitted button for each patient and ultimately guarantee an adequate nutritional intake.

Stepping it up: Physical activity is associated with a lower incidence of prolonged gastric transit time in capsule endoscopy.

BACKGROUND AND AIM: Physical activity has been proposed as a potential factor influencing capsule endoscopy (CE) gastric transit time (GTT). However, there is no reported factual evidence confirming this association. We aimed to prospectively assess the effect of physical activity in the first hour of CE in the occurrence of prolonged GTT. METHODS: This is a prospective study including consecutive patients undergoing CE. For each patient, a step counter was attached to the CE register. The number of steps during the first hour of the procedure was registered. The main outcome was prolonged GTT (CE remaining in the stomach for > 1 h). Outcomes were adjusted for possible confounders by multivariate analysis. RESULTS: We included 100 patients, 60% undergoing small bowel CE and 40% colon CE. The mean number of steps in the first hour was significantly lower in patients with prolonged GTT (2009 ± 1578 steps) comparatively with those without prolonged GTT (3597 ± 1889 steps) (P < 0.001). On multivariate analysis including significant confounders, steps in the first hour were an independent predictor of prolonged GTT (P = 0.018). Single-handedly, the number of steps taken in the first hour had a good acuity for predicting prolonged GTT (area under the curve = 0.74; P < 0.001), with an optimal cut-off of 2000 steps (sensitivity 81.3% and specificity 70%). CONCLUSIONS: Physical activity during the first hour of CE significantly decreased the occurrence of prolonged GTT. These findings pave the way for further definition of clear instructions to give to patients undergoing CE.

Decision-To-Scope Score: A novel tool with excellent accuracy in predicting foreign bodies in the esophagus.

INTRODUCTION: Foreign body (FB) ingestion is a common indication for urgent esophagogastroduodenoscopy (EGD). Nevertheless, most pass spontaneously through the gastrointestinal (GI) tract. Differently from GI bleeding, there is no validated score aiming to identify "low-risk" patients in suspected FB ingestion. We aimed to create a score able to discriminate patients who are candidates to emergent EGD in this scenario. METHODS: Retrospective study of consecutive patients admitted for suspected FB in the upper GI tract between 2016 and 2021. The evaluated outcome was endoscopic confirmation of FB in the esophagus. Variables significantly associated with the outcome on multivariate analysis were computed into a score predicting endoscopic confirmation. RESULTS: We included 228 patients. From these, 97 (42.5%) had a confirmed FB in EGD. Time since ingestion <6 h (OR = 4.0; P = 0.042), absence of any meal after FB ingestion (OR = 7.1; P = 0.005), dysphagia (OR = 11.8; P < 0.001), odynophagia (OR = 4.6; P = 0.004), and drooling (OR = 15.1; P < 0.001) were independent predictors of confirmed FB. These variables were used to compute a FB predicting score-the Decision-To-Scope (DTS) Score: time since ingestion <6 h (+1 point), absence of meals (+2 points), dysphagia (+3 points), odynophagia (+1 point), and drooling (+4 points). DTS-Score had excellent accuracy to predict the outcome (AUC = 0.953; 95%CI = 0.928-0.977; P < 0.001). The optimal cutoff to identify low-risk patients was a score ≤5 (sensitivity 85.0% and specificity 94.7%). CONCLUSIONS: More than half of the suspected FB were not confirmed by EGD. The DTS-Score presented excellent accuracy at stratifying patients' risk and may contribute to the decision to perform emergent EGD in suspected FB ingestion.

Small Bowel CLEansing Assessment and Report (SB-CLEAR): Standardizing bowel preparation report in capsule endoscopy.

BACKGROUND AND AIM: Small-bowel (SB) cleansing is crucial to assess the reliability of capsule endoscopy (CE) findings. However, the presence of multiple grading systems is hampering their use in clinical practice. In 2020, Colon CLeansing Assessment and Report (CC-CLEAR) was created and validated. We sought to develop and validate a new score for the evaluation of the SB cleansing, adapted from CC-CLEAR, aiming to standardize CE reporting regarding the quality of preparation. METHODS: The new grading score, SB CLeansing Assessment and Report (SB-CLEAR), divided the SB into three tertiles, each being scored depending on the percentage of visualized mucosa (0, < 50%; 1, 50%-75%; 2, > 75%; 3, > 90%). The overall classification was a sum of each segment score, graded between excellent, good, and inadequate (0-5). Any segment scoring ≤1 resulted in inadequate overall classification. CE videos were prospectively evaluated by two experienced CE readers blinded to each other. RESULTS: We included 52 CEs, 41(78.8%) female, with a mean age of 57.9 ± 17.9 years. Inter-observer agreement was very strong for each tertile (first: r = 0.863; second: r = 0.865; third: r = 0.861; P < 0.001), which resulted in overall excellent correlation when considering the quality of preparation in all tertiles (r = 0.940; P < 0.001). By applying final classifications of "inadequate," "good," and "excellent," correlation between observers was also very strong (r = 0.875; P < 0.001). CONCLUSIONS: SB-CLEAR is an innovative and reproducible grading score for evaluation of SB preparation quality in CE, with overall excellent inter-observer agreement. Along with CC-CLEAR, this may become a valuable tool to uniformize reporting of bowel preparation quality in CE.

Direct oral anticoagulants are associated with potentially bleeding lesions in suspected mid-gastrointestinal bleeding.

BACKGROUND AND AIM: Direct oral anticoagulants (DOACs) became a widespread alternative in anticoagulant therapy. Nevertheless, concerns are raised about their safety, with increased gastrointestinal bleeding rates being described. There are scarce studies regarding DOACs effect on small-bowel capsule endoscopy (SBCE) findings. We aimed to assess if the detection of lesions with high bleeding potential on SBCE was significantly different in patients treated with DOACs when compared to non-anticoagulated patients and to patients anticoagulated with other agents. METHODS: Cohort study including consecutive patients who underwent SBCE for suspected mid-gastrointestinal bleeding (MGIB) in 2019 and 2020. RESULTS: From 148 patients, 38 (25.7%) were anticoagulated, of which 26 (68.4%) with DOACs. P2 lesions were detected in 36.5% (n = 54) of the patients. These lesions were more frequently detected in patients under DOACs treatment when compared to non-anticoagulated patients (69.2% vs. 29.1%; p=.001), and also when compared to patients treated with other anticoagulants (69.2% vs. 33.3%; p=.037). No differences in P2 lesions detection were observed between patients treated with other anticoagulants and non-anticoagulated patients (33.3% vs. 29.1%; p=.747). In multivariate analysis, DOACs usage was significantly associated with higher detection rates of P2 lesions on SBCE, when adjusted for classical risk factors for MGIB (OR: 3.38; 95%CI = 1.23-9.26; p=.018). CONCLUSIONS: Despite their undeniable cardiovascular benefits and easy applicability, DOACs should still be considered with caution. These drugs were significantly associated with higher risk of potentially bleeding lesions on SBCE when compared to other anticoagulants and represent an independent risk factor for MGIB when adjusted for other variables.

CC-CLEAR (Colon Capsule Cleansing Assessment and Report): the novel scale to evaluate the clinical impact of bowel preparation in capsule colonoscopy - a multicentric validation study.

BACKGROUND: Colon Capsule Cleansing Assessment and Report (CC-CLEAR) is a novel quantitative bowel preparation scale for colon capsule. AIM: The aim of this study is to validate the association between CC-CLEAR's classification and major CC outcomes: lesion detection rate, surveillance recommendations and post-CC endoscopic treatment. METHODS: Multicentric cohort of consecutive CCs. An expert's panel decided post-CC recommendations. Data included CC-CLEAR and Leighton-REX scales. Major CC outcomes were associated with the different cleansing grades. RESULTS: From 168 CC's included, findings were reported in 123 (73.2%), 67 (54.4%) of those being colorectal polyps. CC-CLEAR influenced CC's lesion detection (OR 1.25 95% IC [1.07-1.46], p-value .004) and polyp detection rate (OR 1.22 95% IC [1.04-1.43], p-value.014). Thirty-two (19%) post-CC colonoscopies were recommended, including 22 (68.75%) with at least one polypectomy. CC-CLEAR was associated with post-CC colonoscopy treatment (OR 1.40 95% IC [1.07-1.84], p-value .015). Regarding surveillance, CC-CLEAR influenced the decision for immediate CC repetition (OR 0.21 95% IC [0.12-0.36], p-value < .001) and the recommendation for CC in 3-5 years' time (OR 1.47 95% IC [1.50-1.86], p-value < .002). The Leighton-Rex scale was not correlated with major CC outcomes. CONCLUSION: CC-CLEAR impacts major CC outcomes: lesion detection, surveillance recommendations and post-CC endoscopic treatment.

RHEMITT score: Predicting the risk of mid gastrointestinal rebleeding after small bowel capsule endoscopy: A prospective validation.

BACKGROUND AND AIM: The RHEMITT score (Renal disease; Heart failure; Endoscopic findings; Major bleeding; Incomplete SBCE; Tobacco; Treatment by enteroscopy) was the first score to accurately predict the individual risk of small bowel rebleeding after capsule endoscopy (SBCE). The aim of the study is on the prospective validation of the RHEMITT score. METHODS: Cohort of consecutive patients with mid-gastrointestinal bleeding (MGIB) submitted to SBCE and followed prospectively, during at least 12 months, since 2017 until 2020. Rebleeding was defined as an overt bleeding event (melena or hematochezia) or a hemoglobin decrease of at least 2 g/dL. The RHEMITT score was calculated for each patient and the rebleeding rates compared. The performance of the score was tested by calculating the area under curve of the receiver operator characteristic curve. A rebleeding-free survival was assessed, corresponding to the period between the date of SBCE and the date of the first post-SBCE rebleeding event. RESULTS: We included 162 patients, 102 (62.9%) were female, with a mean age of 64 years old. The sensitivities and specificities of the score grades for predicting rebleeding were as following: for low-risk patients, 0% (0-10%) and 28.8% (21.1-36.5%); for intermediate-risk patients, 23.3% (8.2-38.4%) and 72% (64.3-79.7%); for high-risk patients, 76.7% (61.6-91.8%) and 99.2% (97.7-100%), corresponding to an area under curve of the receiver operator characteristic of 0.988 (P < 0.001). Kaplan-Meyer plots were statistically different according to the attributed risk (log-rank P value <0.001; Breslow-Wilcoxon P value <0.001). CONCLUSION: The RHEMITT score performed with excellent discriminative power in predicting rebleeding risk, and we herewith propose a surveillance of MGIB patients guided by the RHEMITT score.

Apex Score: Predicting Flares in Small-Bowel Crohn's Disease After Mucosal Healing.

BACKGROUND: Optimal strategies for using small-bowel capsule endoscopy (SBCE) in established small-bowel Crohn's disease (CD) remain uncertain. Mucosal healing (MH) has emerged as a valuable predictor of a flare-free disease. We aimed to evaluate the occurrence of disease flare on patients with small-bowel CD and MH, as well as to create a score identifying patients in higher risk for this outcome. METHODS: We analyzed consecutive patients submitted to SBCE for assessment of MH and included those where MH was confirmed. The incidence of disease flare was assessed during follow-up (minimum 12 months). A score predicting disease flare was created from several analyzed variables. RESULTS: From 47 patients with MH, 12 (25.5%) had a flare (versus 48.3% in excluded patients without MH; p = 0.01). Age ≤ 30 years (OR  = 70; p  = 0.048), platelet count ≥ 280 × 103/L (OR  = 12.24; p  =  0.045) and extra-intestinal manifestations (OR  =  11.76; p  =  0.033) were associated with increased risk of CD flare during the first year after SBCE with MH. These variables were used to compute a risk-predicting score-the APEX score-which assigned the patients to having low (0-3 points) or high-risk (4-7 points) of disease flare and had excellent accuracy toward predicting disease relapse (AUC  =  0.82; 95%CI 0.64-0.99). CONCLUSION: Patients with small-bowel CD and MH were not free of disease flares on the subsequent year, despite presenting lower rates when compared to those without MH. The APEX score demonstrated excellent accuracy at stratifying patients relapse risk and guiding further therapeutic options for patients achieving MH.

P020 Proton Pump Inhibitor Therapy: Providing "Acid" Outcomes in Patients With Inflammatory Bowel Disease Under Infliximab Treatment.

BACKGROUND: A recent meta-analysis has suggested that proton pump inhibitor (PPI) therapy is associated with lower clinical remission rates and a higher number of hospitalizations in patients with inflammatory bowel disease (IBD) under infliximab therapy. We aimed to assess if these differences kept their significance when adjusted for other possible confounders. METHODS: Cohort study of consecutive patients with Crohn's disease (CD) and Ulcerative Colitis (UC) under infliximab therapy. A minimum follow-up of 54 weeks after introduction of infliximab treatment was required. The analyzed outcomes were deep remission at week 54 and the need of IBD-related hospitalization, corticosteroid treatment or abdominal surgery under infliximab treatment. Collected possible confounders were age, gender, smoking habits, perianal disease, extra-intestinal manifestations, familiar history of IBD and concomitant use of immunomodulators. RESULTS: Our final sample included 104 patients, 56 (53.8%) of them females, with a mean age of 38.2±13.1 years. From these, 77 (74.0%) had CD and 27 (26.0%) had UC. PPI therapy was described in 21 (20.2%) of the patients under infliximab treatment. On univariate analysis, PPI users were found to have significantly lower rates of deep remission at week 54 (7.7 vs 28.3%; p = 0.034) and higher IBD-related hospitalization rates (47.6 vs 21.7%; p = 0.034). No differences were found regarding the need of corticosteroid therapy (4.8 vs 10.8%; p = 0.398) or abdominal surgery (33.7 vs 21.7; p = 0.201). When adjusted for the collected confounders by multivariate analysis, while not significantly influencing deep remission at week 54 (OR = 0.16; 95%CI = 0.02-1.63; p = 0.121), concomitant PPI therapy was a significant independent risk factor for IBD-related hospitalization (OR = 3.22; 95%CI = 1.11-9.34; p = 0.04). CONCLUSION: Despite not conducting to significantly different deep remission rates, concomitant PPI therapy was associated with a three-fold increase in hospitalization rates in IBD patients under infliximab treatment, even when adjusted for classical risk factors for adverse outcomes in IBD. These findings emphasize the importance of restricting PPI treatment to those with a clear clinical indication, especially in this set of patients.

Colon Capsule CLEansing Assessment and Report (CC-CLEAR): a new approach for evaluation of the quality of bowel preparation in capsule colonoscopy.

BACKGROUND AND AIMS: Current colon capsule (CC) cleansing grading scales rely on subjective parameters and lack proper interobserver agreement. We should strive for higher intra- and interobserver agreement for the evaluation of the cleansing quality of CCs. Here we sought to validate a new grading scale for the evaluation of CC cleansing. METHODS: For the new grading scale, named Colon Capsule CLEansing Assessment and Report (CC-CLEAR), the colon was divided in 3 segments: right-sided, transverse, and left-sided colon. Each segment was scored according to an estimation of the percentage of visualized mucosa (0, <50%; 1, 50%-75%; 2, >75%; 3, >90%). The overall cleansing classification was a sum of each segment score, grading between excellent (8-9), good (6-7), and inadequate (0-5). Any segment scoring ≤1 resulted in inadequate overall classification. Videos were reviewed and scored using CC-CLEAR and the Leighton-Rex grading scale by 2 experienced operators blinded to each other. Kendall's coefficient evaluated inter- and intraobserver agreement. RESULTS: We included 58 consecutive CCs, corresponding to 75.9% women, with a mean age of 65 years. Overall cleansing CC-CLEAR classifications were as follows: reader A, 22.4% (n = 13) excellent, 31% (n = 18) good, and 46.5% (n = 27) inadequate; and reader B, 24.1% (n = 14) excellent, 22.4% (n = 13) good, and 53.4% (n = 31) inadequate. CC-CLEAR interobserver agreement was superior to the Leighton-Rex scale (Kendall's W .911 vs .806, respectively; P < .01). The intraobserver agreement for CC-CLEAR was excellent for both readers (P > .01). CONCLUSIONS: CC-CLEAR is a new practical and reliable grading scale for the evaluation of bowel preparation quality using a CC, with excellent inter- and intraobserver agreement.

Small Bowel Angioectasias Rebleeding and the Identification of Higher Risk Patients.

BACKGROUND: Small bowel capsule endoscopy (SBCE) is the gold standard for suspected small bowel bleeding (SBB). Angioectasias are the most common vascular anomalies in the gastrointestinal tract and have been reported as the source of SBB in up to 80% of patients. Considering their frequency, their usual intermittent bleeding nature, and their risk of rebleeding, the aim of this study was to identify some features and possible predictors of rebleeding in the presence of these lesions. METHODS: This is a retrospective study, which included consecutive SBCE with angioectasias between April 2008 and December 2017 with a minimum follow-up of 12 months. Rebleeding was defined as a drop of hemoglobin ≥ 2 g/dl and/or in the presence of hematochezia or melenas with negative esophagogastroduodenoscopy and ileocolonoscopy. Data were collected from medical records, and angioectasias were classified by number, location, size, and type. Univariate and multivariable statistical analysis was performed to identify possible predictors of rebleeding. RESULTS: From a total of 630 patients submitted to SBCE for suspected SBB, 129 with angioectasias were included; 59.7% were female, with a median age of 72 (19-91) years old and a mean follow-up of 44.0 ± 31.9 months. In 32.6% (n = 42) of the patients, at least one episode of rebleeding was documented. The presence of heart failure (OR 3.41; IC95% 1.18-9.89; p = 0.024), the size of the angioectasias (OR 5.41; IC95% 2.15-13.6; p < 0.001), and smoking status (OR 3.15; IC95% 1.07-9.27; p = 0.038) were independent predictor factors of rebleeding. CONCLUSION: Heart failure, smoking status, and angioectasias with a size superior to 5 mm are independent predictor factors of rebleeding in a population with angioectasias diagnosed by SBCE.

Small-bowel transit time in capsule endoscopy: a determinant factor for the diagnosis of small-bowel bleeding.

BACKGROUND: small-bowel capsule endoscopy (SBCE) is the gold standard for the study of small-bowel bleeding (SBB). Recent studies suggest that longer small-bowel transit times (SBTT) may be associated with a higher diagnostic yield of SBCE. AIM: the aim of the study was to investigate if longer SBTT is a predictive factor of positive findings on SBCE in a population that underwent SBCE for suspected SBB. METHODS: a retrospective single-center study including consecutive SBCEs between May 2012 and May 2019, due to suspected SBB. A positive SBCE was considered in the presence of lesions with high bleeding potential such as ulcers, angioectasias, and tumors (P2 lesions, according to the Saurin classification). RESULTS: we included 372 patients, 65.9 % female, with a median age of 67 (IQR: 19-97) years. We observed that patients with P2 lesions (n = 131; 35.2 %) in SBCE exhibited a longer SBTT (p = 0.01), were older (p < 0.001), were more frequently male (p = 0.019), and suffered more frequently from arterial blood hypertension (p = 0.011), diabetes (p = 0.042), chronic kidney disease (p = 0.003), and heart failure (p = 0.001). In the logistic analysis, significant predictive factors for the presence of P2 lesions included age (OR: 1.027; 95 % CI: 1.009-1.045; p = 0.004), SBTT (OR: 1.002; 95 % CI: 1.001-1.005; p = 0.029), and male gender (OR: 1.588; 95 % CI: 1.001-2.534; p = 0.049). CONCLUSIONS: patients with longer SBTT had higher rates of lesions with high bleeding potential (P2). SBTT along with previously well-defined factors such as age and male gender were the only independent predictive factors for the presence of P2 lesions. These findings may suggest that a slower passage of the capsule through the small bowel may allow a better diagnostic yield for significant lesions.

CECDAIic - a new useful tool in pan-intestinal evaluation of Crohn's disease patients in the era of mucosal healing.

Background: Pan-intestinal capsule endoscopy (Pan-CE) has been used to assess both the small and large bowel inflammation in Crohn's disease (CD) patients in a single examination. The capsule endoscopy Crohn's disease activity index (CECDAI) was initially developed to measure mucosal disease activity in the small bowel, although in 2018, it was extended to the colon for standardization of inflammatory activity (CECDAIic). The aim of this study was to apply the CECDAIic in a cohort of CD patients that underwent Pan-CE to evaluate the inter-observer agreement and the correlation between this score and inflammatory parameters.Methods: The videos were read and scored using the CECDAIic by three independent experienced operators, blinded to the results of the standard workup. Statistical analysis was performed with SPSS®, using Kendall's coefficient to evaluate the inter-observer agreement. Spearman correlation (rs) was used to access the correlation between the score and inflammatory biomarkers.Results: Included 22 patients, 59.1% males with mean age of 30.7 ± 11.1 years. The median CECDAIic score was 9.17 (0-37). The overall CECDAIic score Kendall coefficient was 0.94, demonstrating a statistically significant (p < .001) and excellent agreement between the three observers. In addition, we found a very good correlation between CECDAIic and calprotectin (rs = 0.82; p = .012) and a moderate correlation with C-reactive protein (CRP, rs = 0.50; p = .019).Conclusions: CECDAIic is a new score with excellent inter-observer agreement and strong correlation with calprotectin levels.

How should we select suspected Crohn's disease patients for capsule enteroscopy?

Background: In suspected Crohn's disease (CD), non-diagnostic ileocolonoscopies are often followed by small bowel capsule endoscopy (SBCE). Adequate pre-selection of patients for SBCE is a key to optimize allocation of resources. We aimed to establish a rational approach for the CD diagnostic workflow, based on biochemical profile of patients with suspected CD, targeting an optimization of patients' selection for SBCE. Methods: Multicenter cohort study includes consecutive patients with suspected undergoing SBCE after non-diagnostic ileocolonoscopy. Minimum follow-up period after the capsule enteroscopy was six months. The outcome was confirmation of CD diagnosis. Univariate analysis and logistic regression were performed. Results: In included 220 patients, 62.3% of women were with a mean age of 41 years [26-54]. A confirmed diagnosis of CD was established in 98 patients (44.5%). The initial univariate analysis identified variables above the threshold of marginal statistical association toward CD diagnosis (p < .15). The regression model identified high CRP levels (OR 1.028 p = .128) and low serum Iron (OR 0.990 p = .025) as the independent variables with consistent correlation with CD diagnosis. Those two variables present a suitable discriminative power (AUC = 0.669, p < .001) for the diagnosis of CD. Conclusion: In suspected CD, low serum iron and elevated CRP had a statistically significant association with CD diagnosis, being helpful to identify patients with higher CD probability before SBCE. However, the lack of a proper validation of the model leads us to currently recommend SBCE to all patients with suspected CD and negative ileocolonoscopy, as no specific biochemical profile can be used to confidently exclude small bowel CD.

Primary colon mantle lymphoma: a misleading macroscopic appearance!

Mantle cell lymphoma (MCL) of the colon is a rare entity, usually presenting as lymphomatous polyposis. We report the case of a 43-year-old male with an unusual colonic MCL in the form of a single exophytic and ulcerous lesion with necrotic areas associated with an ileo-cecal intussusception. The endoscopic appearance suggested adenocarcinoma. However, the diagnosis was made by histology and immunohistochemistry studies of the endoscopic biopsies.