An Expert Consensus to Standardize Assessment of Bowel Cleansing for Clinical Trials of Bowel Preparations for Crohn's Disease.

BACKGROUND: Despite regular need for colonoscopy in patients with Crohn's disease (CD), the efficacy and tolerability of bowel preparation (BP) agents is rarely assessed in this population. Assessing BP quality with existing scales may be challenging in CD due to presence of inflammation, bowel resection, and strictures. AIMS: To provide recommendations for assessing BP quality in clinical trials for CD using a modified Research and Development/University of California, Los Angeles appropriateness process. METHODS: Based on systematic reviews and a literature search, 110 statements relating to BP quality assessment in CD were developed. A panel of 15 gastroenterologists rated the statements as appropriate, uncertain, or inappropriate using a 9-point Likert scale. RESULTS: Panelists considered it appropriate that central readers, either alone or with local assessment, score BP quality in clinical trials. Central readers should be trained on scoring BP quality and local endoscopists on performing high-quality video recording. Both endoscope insertion and withdrawal phases should be reviewed to score BP quality in each colonic segment and segments should align with endoscopic disease activity indices. The Harefield Cleansing Scale and the Boston Bowel Preparation Scale were considered appropriate. The final score should be calculated as the average of all visualized segments. Both total and worst segment scores should also be assessed. CONCLUSIONS: We developed a framework for assessing BP quality in patients with CD based on expert feedback. This framework could support the development or refinement of BP quality scales and the integration of BP quality assessment in future CD studies.

A Multicenter Randomized Controlled Trial Comparing Two Bowel Cleansing Regimens for Colonoscopy After Failed Bowel Preparation.

BACKGROUND & AIMS: Failed bowel preparation for colonoscopy occurs commonly, but the optimal regimen for the subsequent attempt is unknown. High-volume preparations often are used but are not well studied. The objective of this study was to compare the efficacy, tolerability, and safety of 2 regimens for use after failed bowel preparation. METHODS: A multicenter, endoscopist-blinded randomized controlled trial was conducted in patients who previously failed bowel preparation despite adequate compliance. Patients were randomized to 1 of 2 split polyethylene glycol (PEG) regimens, preceded by 15 mg bisacodyl: PEG 2 L the evening before and 2 L the day of colonoscopy (PEG 2+2L+bisacodyl), or 4 L and 2 L (PEG 4+2L+bisacodyl). All patients followed a low-fiber diet on both the third and second day before the procedure, followed by a clear fluid diet the day before and the morning of the colonoscopy. The primary outcome was adequate bowel preparation, defined as a Boston Bowel Preparation Scale total score of 6 or higher, with all segment scores of 2 or higher. Secondary outcomes included adenoma detection rate, advanced adenoma detection rate, sessile serrated lesion detection, cecal intubation rate, tolerability, and adverse events. RESULTS: A total of 196 subjects were randomized at 4 academic centers in Canada (mean age, 60.7 y; SD, 11.4 y; 44.9% were women). There were no significant differences between the PEG 2+2L+bisacodyl and the PEG 4+2L+bisacodyl groups in achieving adequate bowel preparation (91.2% vs 87.6%; P = .44). There were no significant differences with regard to mean adenoma detection rate (37.4% vs 31.5%; P = .41), advanced adenoma detection rate (18.7% vs 11.2%; P = .16), sessile serrated lesion detection (8.8% vs 5.6%; P = .41), and cecal intubation rate (96.7% vs 92.1%; P = .19). The 2 regimens were similarly well tolerated, but PEG 2+2L+bisacodyl was associated with a higher willingness to repeat the bowel preparation (91.2% vs 66.2%; P < .001). CONCLUSIONS: Split-dose 4 L-PEG with 15 mg bisacodyl, along with dietary restrictions, has similar efficacy as a higher-volume preparation, and should be considered for patients who previously failed bowel preparation (ClinicalTrials.gov number, NCT02976805).

Reliability of the Endoscopic Ultrasound Ulcerative Colitis (EUS-UC) score for assessment of inflammation in patients with ulcerative colitis.

Background and study aims Endoscopic ultrasound (EUS) may be a useful modality for disease assessment and risk stratification in ulcerative colitis. We assessed the reliability of a newly developed EUS index of inflammation called the EUS-Ulcerative Colitis (EUS-UC) score. Patients and methods The EUS-UC score components include total wall thickness, hyperemia, and depth of inflammation (DOI). Three blinded expert endosonographers assessed EUS videos of 58 patients with UC in triplicate. Intra- and inter-rater reliability of the hyperemia and DOI component scores were estimated using intra-class correlation coefficients (ICCs). Total wall thickness reliability estimates could not be assessed in this study. The ICCs were compared to the original indices from which they were derived. Results For hyperemia, the inter-class ICC was "moderate" at 0.556 (95 % CI = 0.434-0.651) and the intra class ICC was "almost perfect" at 0.884 (95 % CI = 0.835-0.920). The newly defined hyperemia score performed better than the original index from which is was derived. The DOI inter-class ICC was "fair" at 0.335 (95 % CI = 0.201-0.464), and the intra-class ICC was "substantial" at 0.732 (95 % CI = 0.642-0.802). The DOI reliability estimates were similar to the original index from which it was derived. Conclusions The hyperemia component of the EUS-UC score performed significantly better than the original index from which it was derived, but the reliability of the DOI component was suboptimal. Intra-class correlation was excellent for both components. The EUS-UC score is a promising instrument for assessment of UC and further validation is required.

External Validation of the Oakland Score to Assess Safe Hospital Discharge Among Adult Patients With Acute Lower Gastrointestinal Bleeding in the US.

Importance: Lower gastrointestinal bleeding (LGIB), which manifests as blood in the colon or anorectum, is a common reason for hospitalization. In most patients, LGIB stops spontaneously with no in-hospital intervention. A risk score that could identify patients at low risk of experiencing adverse outcomes could help improve the triage process and allow greater numbers of patients to receive outpatient management of LGIB. Objective: To externally validate the Oakland Score, which was previously developed using a score threshold of 8 points to identify patients with LGIB who are at low risk of adverse outcomes. Design, Setting, and Participants: This multicenter prognostic study was conducted in 140 US hospitals in the Hospital Corporation of America network. A total of 46 179 adult patients (aged ≥16 years) admitted to the hospital with a primary diagnosis of LGIB between June 1, 2016, and October 15, 2018, were initially identified using diagnostic codes. Of those, 51 patients were excluded because they were more likely to have upper gastrointestinal bleeding, leaving a study population of 46 128 patients with LGIB. For the statistical analysis of the Oakland Score, an additional 8061 patients were excluded because they were missing data on Oakland Score components or clinical outcomes, resulting in 38 067 patients included in the analysis. The study used area under the receiver operating characteristic curves with 95% CIs for external validation of the model. Sensitivity and specificity were calculated for each score threshold (≤8 points, ≤9 points, and ≤10 points). Data were analyzed from October 16, 2018, to September 4, 2019. Main Outcomes and Measures: Identification of patients who met the criteria for safe discharge from the hospital and comparison of the performance of 2 score thresholds (≤8 points vs ≤10 points). Safe discharge was defined as the absence of blood transfusion, rebleeding, hemostatic intervention, hospital readmission, and death. Results: Among 46 128 adult patients with LGIB, the mean (SD) age was 70.1 (16.5) years; 23 091 patients (50.1%) were female. Of those, 22 074 patients (47.9%) met the criteria for safe discharge from the hospital. In this group, the mean (SD) age was 67.9 (18.1) years, and 11 056 patients (50.1%) were female. In the statistical analysis of the Oakland Score, which included only the 38 067 patients with complete data, the area under the receiver operating characteristic curve for safe discharge was 0.87 (95% CI, 0.87-0.87). An Oakland Score threshold of 8 points or lower identified 3305 patients (8.7%), with a sensitivity and specificity for safe discharge of 98.4% and 16.0%, respectively. Extension of the Oakland Score threshold to 10 points or lower identified 6770 patients (17.8%), with a sensitivity and specificity for safe discharge of 96.0% and 31.9%, respectively. Conclusions and Relevance: In this study, the Oakland Score consistently identified patients with acute LGIB who were at low risk of experiencing adverse outcomes and whose conditions could safely be managed without hospitalization. The score threshold to identify low-risk patients could be extended from 8 points or lower to 10 points or lower to allow identification of a greater proportion of low-risk patients.

Insertion of percutaneous endoscopic gastrostomy tubes with jejunal extensions using the "wedge" technique: a novel method to prevent retrograde tube migration into the stomach.

Background and study aim In percutaneous endoscopic gastrostomy (PEG) with jejunal extension (PEGJ) procedures, retrograde migration of the jejunal extension tube into the stomach during endoscope withdrawal is a frustrating problem. We describe the novel "wedge" technique for inserting the jejunal extension tube, utilizing single-balloon enteroscopy to anchor it in place. Patients and methods Prospective 1-year study of consecutive patients undergoing PEGJ insertion at a single tertiary care center. The primary outcome was number of pyloric intubations required to place the jejunal extension tube. Secondary outcomes included success rate, time, and complications related to jejunal extension tube insertion. Results 17 patients underwent the procedure. The jejunal extension tube was inserted at the first attempt in 15 patients (88.2 %) and 2 required another pyloric intubation. Abdominal X-ray showed that all PEGJ tubes were successfully seated in the proximal jejunum. The mean (SD) time required for jejunal extension insertion was 16.9 (8.6) minutes. Two adverse events occurred due to PEG insertion although none were related to the jejunal extension insertion itself. Conclusions: The "wedge" technique is an effective and easy method for inserting a jejunal extension tube after PEG insertion.

Effectiveness and safety of serial endoscopic ultrasound-guided celiac plexus block for chronic pancreatitis.

BACKGROUND AND STUDY AIMS: Endoscopic ultrasound - guided celiac plexus block (EUS-CPB) is an established treatment for pain in patients with chronic pancreatitis (CP), but the effectiveness and safety of repeated procedures are unknown. Our objective is to report our experience of repeated EUS-CPB procedures within a single patient. PATIENTS AND METHODS: A prospectively maintained EUS database was retrospectively analyzed to identify patients who had undergone more than one EUS-CPB procedure over a 17-year period. The main outcome measures included number of EUS-CPB procedures for each patient, self-reported pain relief, duration of pain relief, and procedure-related adverse events. RESULTS: A total of 248 patients underwent more than one EUS-CPB procedure and were included in our study. Patients with known or suspected CP (N = 248) underwent a mean (SD) of 3.1 (1.6) EUS-CPB procedures. In 76 % of the patients with CP, the median (range) duration of the response to the first EUS-CPB procedure was 10 (1 - 54) weeks. Lack of pain relief after the initial EUS-CPB was associated with failure of the next EUS-CPB (OR 0.17, 95 %CI 0.06 - 0.54). Older age at first EUS-CPB and pain relief after the first EUS-CPB were significantly associated with pain relief after subsequent blocks (P = 0.026 and P = 0.002, respectively). Adverse events included peri-procedural hypoxia (n = 2) and hypotension (n = 1) and post-procedural orthostasis (n = 2) and diarrhea (n = 4). No major adverse events occurred. CONCLUSIONS: Repeated EUS-CPB procedures in a single patient appear to be safe. Response to the first EUS-CPB is associated with response to subsequent blocks.

Intravascular hemolysis secondary to aorto-atrial fistula presenting as red urine.

Intravascular hemolysis is a rare but potentially life threatening cause of red urine characterized by brisk hemolysis and release of large amounts of hemoglobin into the urine. We present an unusual case of red urine in a 20-year-old male who was subsequently diagnosed with intravascular hemolysis due to an aorto-atrial fistula. Fistula formation was likely secondary to a recently implanted atrial septal occluder, which is a reported but exceedingly rare complication of the device. We discuss the diagnostic approach to hemolytic anemia and conclude with a literature review of other cases of device associated fistula formation and hemolysis.