Smartphone Application Versus Standard Instruction for Colonoscopic Preparation: A Randomized Controlled Trial.

OBJECTIVE: To compare smartphone application (Colonoscopic Preparation) instructions versus paper instructions for bowel preparation for colonoscopy. BACKGROUND: Adhering to bowel preparation instructions is important to ensure a high-quality colonoscopy. PATIENTS AND METHODS: This randomized controlled trial included individuals undergoing colonoscopy at a tertiary care hospital. Individuals were randomized (1:1) to receive instructions through a smartphone application or traditional paper instructions. The primary outcome was the quality of the bowel preparation as measured by the Boston Bowel Preparation Score. Secondary outcomes included cecal intubation and polyp detection. Patient satisfaction was assessed using a previously developed questionnaire. RESULTS: A total of 238 individuals were randomized (n = 119 in each group), with 202 available for the intention-to-treat analysis (N = 97 in the app group and 105 in the paper group). The groups had similar demographics, indications for colonoscopy, and type of bowel preparation. The primary outcome (Boston Bowel Preparation Score) demonstrated no difference between groups (Colonoscopic Preparation app mean: 7.26 vs paper mean: 7.28, P = 0.91). There was no difference in cecal intubation (P = 0.37), at least one polyp detected (P = 0.43), or the mean number of polyps removed (P = 0.11). A higher proportion strongly agreed or agreed that they would use the smartphone app compared with paper instructions (89.4% vs 70.1%, P = 0.001). CONCLUSIONS: Smartphone instructions performed similarly to traditional paper instructions for those willing to use the application. Local patient preferences need to be considered before making changes in the method of delivery of medical instructions.

Comparison of Predictive Models for Prevention of Missed Endoscopy Appointments- failure of a Predictive Model to Outperform Overbooking Model.

BACKGROUND: Patient late cancelation and nonattendance for endoscopy appointments is an ongoing problem affecting the productivity and wait times of endoscopy units. Previous research evaluated a model for predictive overbooking and had promising results. STUDY: All endoscopy visits at an outpatient endoscopy unit during 4 nonconsecutive months were included in the data analysis. Patients who did not attend their appointment, or canceled with 48 hours of their appointment were considered nonattendees. Demographic, health, and prior visit behavior data was collected and the groups compared. RESULTS: 1780 patients attended 2331 visits in the study period. Comparing the attendee versus non-attendees, there were significant differences in mean age, prior absenteeism, prior cancelations, and total number of hospital visits. No significant differences were seen between groups in winter versus non-winter months, the day of the week, sex distribution, type of procedure booked, or whether the referral was from specialist clinic or direct to procedure. The visit cancelation proportion (calculated excluding current visit) was substantially higher in the absentee group ( P <0.0001). A predictive model was developed and compared to current booking as well as a straight overbooking of 7%. Both overbooking models performed better than the current practice, but the predictive overbooking model did not outperform straight overbooking. CONCLUSIONS: Developing an endoscopy unit specific predictive model may not be more beneficial than straight overbooking as calculated by missed appointment percentage.

Creation of EGD-Derived Gastric Cancer Organoids to Predict Treatment Responses.

Gastric adenocarcinoma (GAd) is the third leading cause of cancer-related deaths worldwide. Most patients require perioperative chemotherapy, yet methods to accurately predict responses to therapy are lacking. Thus, patients may be unnecessarily exposed to considerable toxicities. Here, we present a novel methodology using patient-derived organoids (PDOs) that rapidly and accurately predicts the chemotherapy efficacy for GAd patients. Methods:Endoscopic GAd biopsies were obtained from 19 patients, shipped overnight, and PDOs were developed within 24 h. Drug sensitivity testing was performed on PDO single-cells with current standard-of-care systemic GAd regimens and cell viability was measured. Whole exome sequencing was used to confirm the consistency of tumor-related gene mutations and copy number alterations between primary tumors, PDOs, and PDO single-cells. Results:Overall, 15 of 19 biopsies (79%) were appropriate for PDO creation and single-cell expansion within 24 h of specimen collection and overnight shipment. With our PDO single-cell technique, PDOs (53%) were successfully developed. Subsequently, two PDO lines were subjected to drug sensitivity testing within 12 days from initial biopsy procurement. Drug sensitivity assays revealed unique treatment response profiles for combination drug regimens in both of the two unique PDOs, which corresponded with the clinical response. Conclusions:The successful creation of PDOs within 24 h of endoscopic biopsy and rapid drug testing within 2 weeks demonstrate the feasibility of our novel approach for future applications in clinical decision making. This proof of concept sets the foundation for future clinical trials using PDOs to predict clinical responses to GAd therapies.

Standardizing Scoring Conventions for Crohn's Disease Endoscopy: An International RAND/UCLA Appropriateness Study.

BACKGROUND AND AIMS: Endoscopic assessment of disease activity is integral for evaluating treatment response in patients with Crohn's disease (CD). We aimed to define appropriate items for evaluating endoscopic activity and conventions for consistent endoscopic scoring rules in CD. METHODS: A 2-round modified RAND/University of California at Los Angeles Appropriateness Method study was conducted. A panel of 15 gastroenterologists used a 9-point Likert scale to rate the appropriateness of statements pertaining to the Simple Endoscopic Score for CD, Crohn's Disease Endoscopic Index of Severity, and additional items relevant to endoscopy scoring in CD. Each statement was voted as appropriate, uncertain, or inappropriate based on the median panel rating and presence of disagreement. RESULTS: Panelists voted that it is appropriate for all ulcers to contribute to endoscopic scoring in CD, including aphthous ulcers, ulcerations at a surgical anastomosis, and anal canal ulcers (scored in the rectum). Endoscopic healing should reflect an absence of ulcers. Narrowing should be defined as a clear decrease in luminal diameter; stenosis should be defined by an impassable narrowing, and if occurring at the junction of 2 segments, scored in the distal segment. Scarring and inflammatory polyps were considered inappropriate for including in the affected area score. The optimal method for defining ulcer depth remains uncertain. CONCLUSIONS: We outlined scoring conventions for the Simple Endoscopic Score for CD and Crohn's Disease Endoscopic Index of Severity, noting that both scores have limitations. Therefore, we identified priorities for future research and steps for developing and validating a more representative endoscopic index in CD.

Acute Pancreatitis as a First Presentation of Granulomatosis With Polyangiitis.

Granulomatosis with polyangiitis (GPA) is a rare necrotizing antineutrophil cytoplasmic antibody-associated vasculitis characterized by inflammation in small-sized arteries. Gastrointestinal involvement is exceedingly rare in GPA. Here, we present a case of recurrent acute pancreatitis as the initial presentation of GPA. The diagnosis was made based on radiological and pathological findings of acute pancreatitis in conjunction with positive anti-PR3 antibody which is strongly associated with GPA. Systemic vasculitides are rare but important to consider in cases of idiopathic acute pancreatitis. Early diagnosis and therapy allow for high rates of remission and improved survival rates.

Existing Bowel Preparation Quality Scales Are Reliable in the Setting of Centralized Endoscopy Reading.

BACKGROUND: Development of bowel preparation products has been based upon colon cleansing rating by a local endoscopist. It is unclear how bowel preparation scales perform when centrally evaluated. AIMS: To evaluate the reliability of bowel preparation quality scales when assessed by central readers. METHODS: Four central readers evaluated 52 videos in triplicate, 2 weeks apart, during the entire endoscopic procedure (insertion/withdrawal of the colonoscope) and exclusively on colonoscope withdrawal using the Boston Bowel Preparation Scale (BBPS), Chicago Bowel Preparation scale, Harefield Cleansing Scale, Ottawa Bowel Preparation Quality Scale (OBPQS), Aronchick score, a visual analogue scale, and additional items proposed in a modified Research and Development/University of California Los Angeles appropriateness process. Reliability was assessed with intraclass correlation coefficients. RESULTS: Intraclass correlation coefficients (95% confidence interval) for inter-rater reliability of the quality scales ranged from 0.51 to 0.65 (consistent with moderate to substantial inter-rater reliability) during the entire procedure. Corresponding intraclass correlation coefficients for intra-rater reliability ranged from 0.69 to 0.77 (consistent with substantial intra-rater reliability). Reliability was highest in the right colon and lowest in the left colon. No differences were observed in reliability when assessed for the procedure overall (insertion/withdrawal) relative to assessment on withdrawal alone. CONCLUSION: All five bowel preparation quality scales had moderate to substantial inter-rater reliability. Panelists considered the Aronchick score too simplistic for clinical trials and recognized that assessment of residual fluid in the Ottawa Bowel Preparation Quality Scale was not amenable to central assessment.

A Randomized Controlled Pilot Study of Topical Ropivacaine for Prevention of Post-POEM Pain.

Background and Aims: Although usually mild to moderate in severity, postoperative pain after peroral endoscopic myotomy (POEM) is common. There are no studies that have addressed minimizing postoperative pain in patients undergoing POEM for achalasia. We hypothesized that intraoperative topical intra-tunnel irrigation with ropivacaine would result in a significant reduction in pain scores in the postoperative period. Methods: A double-blind, randomized, placebo-controlled trial was conducted at the Kingston Health Sciences Center. Patients received either 30 mL of 0.2% ropivacaine or 30 mL of placebo irrigated topically into the POEM tunnel after completing the myotomy and prior to closing the mucosal incision. The primary outcome was pain post-POEM at 6 h assessed by the Numeric Rating Scale (NRS). Secondary objectives included assessing pain score at 0.5, 1, 2, 4 h post-POEM and on discharge, Quality of Recovery (QoR-15) scores at discharge, narcotic requirement, adverse events, and patients' willingness to have the procedure done on an outpatient basis. Results: A total of 20 patients were enrolled. For the primary outcome of pain post-POEM at 6 h, the NRS was 1.1 in the placebo group and 2.4 in the ropivacaine group (95% CI of the difference: -3.2 to 0.6, P = 0.171). No statistical difference was seen in the pain scores. Overall usage of post-procedural narcotics was low with no differences between the two groups. Fifty percent of patients in both groups were willing to have the procedure done as an outpatient. Conclusion: The addition of intra-procedural tunnel irrigation with 30 mL 0.2% ropivacaine did not lead to reduced post-POEM pain.

Fistulotomy-First Approach is Safe and Effective in Endoscopic Retrograde Cholangiography: Results of a Prospective Case Series.

BACKGROUND AND AIMS: The aim of this study was to assess the safety and efficacy of using needle-knife fistulotomy (NKF) as a primary cannulation technique in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) with a native papilla. PATIENTS AND METHODS: This prospective feasibility study enrolled 50 patients between December 2018 and June 2019. The procedure was performed by two expert endoscopists (R.B. and L.H.). The primary outcome was the incidence of post-ERCP pancreatitis. Other variables assessed included the success rate of cannulation of the common bile duct (CBD), time to successful cannulation, and incidence of adverse events. RESULTS: Between December 2018 and June 2019, 50 patients enrolled in the study. The mean age was 63.4 years (standard deviation 18.1), and there were 26 females. Indications included biliary obstruction secondary to malignancy (n = 14) and choledocholithiasis (n = 36). Successful cannulation of the CBD through the fistulotomy occurred in 49/50 cases. The time to successful cannulation was 5.1 minutes (range 0.5 to 23 minutes). Mild acute pancreatitis occurred in two cases (4%). Post-ERCP bleeding occurred in three patients (6%). CONCLUSIONS: In this pilot study, NKF was used as the primary biliary access technique and it was demonstrated that it appears to be at least as safe as the traditional access technique with a sphinctertome. However, its role as a primary cannulation technique requires further investigation with multicenter, randomized control studies.

The who, what, where, how, and why of endoscopic submucosal dissection in Canada: A survey among Canadian endoscopists.

BACKGROUND AND AIM: Endoscopic submucosal dissection (ESD) is an internationally accepted technique for the resection of superficial gastrointestinal neoplasia. ESD allows for en-bloc removal when endoscopic mucosal resection (EMR) is unsuitable due to the size or depth of the lesion. The aim of this survey was to examine Canadian clinicians' experience and perceptions of ESD as its prevalence increases across the country. METHODS: An electronic survey consisting of 24 multiple-choice questions was distributed via the Canadian Association of Gastroenterology email database and directly to those known to be performing or interested in ESD. The survey covered training, practice, obstacles in implementation, and perceptions of the future of ESD in Canada. RESULTS: A total of 21 participants completed the survey. ESD was performed primarily in the endoscopy suite exclusively (71%), and most operators (64%) performed it on an outpatient basis. Procedure time was selected as the greatest technical challenge in the performance of ESD by 86% of the participants. Both lack of formalized training and long procedure times were the highest ranked barriers to the adoption of ESD. Over the next 5 years, 95% believed there would be an increase in ESD volume in Canada, and 43% believed ESD was ready for adoption by more therapeutic endoscopists. INTERPRETATION: In this survey, we explored the current practice, attitude, and challenges of ESD in the Canadian landscape. As the performance of ESD increases and gains more acceptance across Canada, there are opportunities to address technical challenges and barriers through the formalization of training, education, and practice guidelines.

Taking the Next Steps in Endoscopic Visual Assessment of Barrett's Esophagus: A Pilot Study.

PURPOSE: Patients with Barrett's esophagus (BE) undergo surveillance endoscopies to assess for pre-cancerous changes. We developed a simple endoscopic classification method for predicting non-dysplastic BE (NDBE), low-grade dysplasia (LGD)/indefinite for dysplasia (ID) and high-grade dysplasia (HGD)/early esophageal adenocarcinoma (EAC). PATIENTS AND METHODS: Twenty-two patients with BE underwent endoscopy using the PENTAX Medical MagniView gastroscope and OPTIVISTA processor. Sixty-six video-still images were analyzed to characterize the microsurface, microvasculature and the presence of a demarcation line. Class A was characterized by regular microvascular and microsurface patterns and absence of a demarcation line, class B by changes in the microvascular and/or microsurface patterns compared to the background mucosa with presence of a demarcation line, and class C by irregular microvascular and/or irregular microsurface patterns with presence of a demarcation line. RESULTS: Of the class A images, 97.9% were NDBE. For class B, 69.2% were LGD/ID and 30.8% NDBE. One hundred percent of the class C samples were HGD/EAC. The sensitivity of our classification system was 93.8%, specificity 92%, positive predictive value 78.9%, negative predictive value 97.9% and an accuracy 92.4%. CONCLUSION: In this study, we developed a simple classification system for the prediction of NDBE, LGD/ID and HGD/EAC. Its real-time clinical applicability will be validated prospectively.

Colonoscopy Trainers Experience Greater Stress During Insertion than Withdrawal: Implications for Endoscopic Curricula.

BACKGROUND: Optimal colonoscopy training curricula should minimize stress and cognitive load. This study aimed to determine whether withdrawal or insertion colonoscopy skills training is associated with less stress or cognitive load for trainees or trainers. METHODS: In Phase I, participants were randomized to train on either insertion or withdrawal in a simulated environment. In Phase II, participants were randomized to begin with either insertion or withdrawal in patient encounters. Salivary cortisol levels, heart rate, and State-Trait Anxiety Inventory (STAI) surveys were used to assess stress in trainees and trainers. NASA Task Load Index (TLX) survey was used to assess cognitive workload in trainees. RESULTS: In Phase I, trainee stress increased during the simulation training during both withdrawal and insertion compared to baseline, while trainer stress changed minimally. Cognitive load was higher for trainees during withdrawal (P = 0.005). In Phase II, trainers' STAI scores were greater during insertion training (P = 0.013). Trainees' stress was highest prior to beginning patient training and decreased during training, while trainer's stress increased during training. Trainees reported insertion training being of greater value (70.0%), while trainers reported withdrawal was preferred (77.8%). CONCLUSION: Trainees and trainers exhibit important differences in stress during colonoscopy skills training. Trainees reported more stress during simulation training and greatest cognitive load during simulation withdrawal, whereas trainers reported greatest stress during patient encounters, particularly training of insertion techniques. Attention to the effect of stress on trainees and trainers and the drivers of stress is warranted and could be incorporated in competency based medical education.

Canadian Association of Gastroenterology Communique: After-Hours Endoscopy Cart.

BACKGROUND: Endoscopic procedures performed after-hours often require therapeutic interventions that are technically demanding for the endoscopist. The aim of this position paper is to provide guidance on the minimum standard of equipment that should be available on a mobile endoscopy cart for provision of a safe and effective after-hours emergency endoscopy service. The guidance is based on consensus among academic and community gastroenterologists in Canada. METHODS: A modified Delphi process was used to establish consensus among 9 participants. A list of statements was prepared by an expert panel of endoscopists. The statements were divided into three broad sections for what should be on an after-hours endoscopy cart including medications, nonendoscopic tools and therapeutic/diagnostic equipment. Consensus for being on the endoscopy cart was achieved when 75% or more of voting members indicated 'agree'. RESULTS: For nonendoscopic tools, there was agreement for having sterile saline, sterile water, endoscope lubricant, various syringes, bite blocks (paediatric and adult size), a water pump with foot peddle, formalin jars for biopsy specimens, digital photo and printing capability and an overtube. For medications, there was agreement for having hyoscine butylbromide and epinephrine on the cart. For therapeutic/diagnostic tools, there was agreement for having biopsy forceps (standard and jumbo), polypectomy snares, sclerotherapy needles and agent (for a variceal bleed), band ligation kit, multipolar electrocautery probes, heater probe catheter, endoscopic clips, hemostatic powder and retrieval devices. INTERPRETATION: This position paper provides guidance on the minimum standard of items that should be on an after-hours endoscopy cart. Standardization of equipment may help improve safety and quality of after-hours endoscopic procedures.

Gastroscopy Should Come Before Colonoscopy Using CO2 Insufflation in Same Day Bidirectional Endoscopies: A Randomized Controlled Trial.

BACKGROUND AND AIMS: Same day bidirectional endoscopies (esophagogastroduodenoscopies [EGD]s and colonoscopies) are routinely performed. However, the best sequence of procedures is unknown, as is whether the use of carbon dioxide (CO2) affects the preferred sequence of procedures. This study aims to determine the preferred sequence of procedures and choice of insufflation gas (air or CO2) in patients undergoing same day bidirectional endoscopies. METHODS: Two hundred adults with a clinical indication for same day bidirectional endoscopies were randomized equally into four groups: A1 (EGD first, CO2 as insufflator); A2 (EGD first, air as insufflator); B1 (colonoscopy first, CO2 as insufflator); and B2 (colonoscopy first, air as insufflator). All procedures were performed with conscious sedation (Midazolam/Fentanyl). The primary outcome was patients' overall comfort/satisfaction with the procedures and sedation received, as assessed by questionnaires and validated scoring scales (Nurse-Assessed Patient Comfort Score [NAPCOMS], La Crosse [WI]) collected during the procedures, before discharge, and on day 7 postprocedure. RESULTS: Two hundred patients were randomized, with data available for 186. Mean Midazolam dose between groups was significantly less in the EGD first groups (P=0.01). During the procedures, no differences were found in patients' comfort as per the nurse reported NAPCOMS scores (P=0.19) or the Lacrosse (WI) endoscopy scores (P=0.05). On postprocedure days 0 and 7, no differences were found in the patients' reported Lacrosse (WI) scores, nausea, sore throat, dizziness, satisfaction with sedation or overall level of procedural satisfaction (P>0.05 for each). However, bloating and discomfort were significantly lower in the CO2 arms (P<0.001). CONCLUSIONS: This randomized controlled trial using validated patient comfort scoring assessments for same day bidirectional endoscopies demonstrated that the sequence of procedures affects the sedation used but does not affect overall patient comfort or satisfaction. Lesser sedation is needed in the EGD first group, and less postprocedural abdominal pain/discomfort and bloating is seen with CO2 insufflation.

Does It work in Clinical Practice? A Comparison of Colonoscopy Cleansing Effectiveness in Clinical Practice Versus Efficacy from Selected Prospective Trials.

BACKGROUND: Adequate bowel preparation is essential for a high-quality colonoscopy. Many randomized controlled trials (RCTs) have investigated bowel preparation protocols, including split-dose and low-volume regimens. However, RCTs are conducted in an ideal, controlled setting, and translation of trial results to clinical practice is challenging. In this study, we compared the quality of bowel preparations of real-world patients from clinical practice with those enrolled in several prospective trials. METHODS: Bowel preparation quality, defined by the Ottawa Bowel Preparation Scale (OBPS), from four RCTs and one prospective trial were compared with two observational diary studies. Bowel preparations were polyethylene glycol preparation (PEG) or sodium picosulfate plus magnesium citrate (P/MC) taken via traditional or split-dose timing regimen. Age, sex, average number of bowel movements per day, comorbidities, colonoscopy indication and colonoscopy completion rates were also collected. RESULTS: Patients enrolled in prospective trials had a better OBPS by one point when compared with those in observational clinical practice studies (P<0.049), after controlling for age, sex, colonoscopy indication and type of bowel preparation used. We also found that each 10-year increase in age was associated with a 0.2 point increase in OBPS (P=0.008), and men were associated with a 0.5 increase in OBPS when compared with women P=0.014). CONCLUSION: Patients from clinical practice have higher OBPS than prospective trial patients. Increased age and male sex were also associated with increased OBPS. We believe increased patient motivation and education around bowel preparation regimen plays an important role in the success of bowel preparations.

Efficacy, safety, and tolerability of a ready-to-drink bowel preparation in overweight and obese adults: subanalysis by body mass index from a phase III, assessor-blinded study.

BACKGROUND: We performed a post hoc secondary analysis for the effect of body mass index (BMI) on the efficacy, tolerability, and safety of ready-to-drink sodium picosulfate, magnesium oxide, and citric acid (SPMC oral solution) bowel preparation. METHODS: A phase III, randomized, assessor-blinded, multicenter, noninferiority study was conducted comparing split-dose, low-volume SPMC oral solution with a powder formulation for oral solution. A post hoc secondary analysis assessed efficacy, safety, and tolerability of SPMC oral solution stratified by BMI. BMI was classified by Centers for Disease Control and Prevention definitions (underweight and normal weight: BMI < 25 kg/m2; overweight: BMI 25-29.9 kg/m2; class I obesity: BMI 30-34.9 kg/m2; class II obesity: BMI 35-39.9 kg/m2; class III/severe obesity: BMI ⩾40 kg/m2). Prespecified primary efficacy endpoint ('responders') was the proportion of participants with 'excellent' or 'good' ratings on a modified Aronchick Scale (AS). Secondary efficacy outcomes were the quality of cleansing of the right colon as assessed by the Boston Bowel Preparation Scale (BBPS); as well as selected findings from the Mayo Clinic Bowel Prep Tolerability Questionnaire. Safety assessments included adverse events (AEs) and laboratory evaluations. RESULTS: Between 82.8% and 92.5% of participants in any BMI group were responders by AS, and between 91.3% and 100% were responders by BBPS in the right colon. Efficacy was consistent across BMI groups, with no clear trends. Greater than 83% of participants in any BMI group found the preparation 'easy' or 'acceptable' to ingest, and the majority (>58%) rated SPMC oral solution as 'better' than a prior bowel preparation. In all BMI groups, safety data were similar to the overall cohort. Commonly reported, drug-related, treatment-emergent AEs were, by ascending BMI group, nausea (1.1%, 5.3%, 1.0%, 5.7%, and 0%) and headache (1.1%, 4.1%, 1.0%, 5.7%, and 0%). CONCLUSIONS: Ready-to-drink SPMC oral solution had consistent, good quality colon cleansing, and favorable tolerability among participants of all BMI groups. CLINICALTRIALSGOV REGISTRATION: NCT03017235.

Prophylactic Endoscopic Clipping Does Not Prevent Delayed Postpolypectomy Bleeding in Routine Clinical Practice: A Propensity Score-Matched Cohort Study.

INTRODUCTION: Delayed postpolypectomy bleeding (DPPB) is a relatively common adverse event. Evidence is conflicting on the efficacy of prophylactic clipping to prevent DPPB, and real-world effectiveness data are lacking. We aimed to determine the effectiveness of prophylactic clipping in preventing DPPB in a large screening-related cohort. METHODS: We manually reviewed records of patients who underwent polypectomy from 2008 to 2014 at a screening facility. Endoscopist-, patient- and polyp-related data were collected. The primary outcome was DPPB within 30 days. All unplanned healthcare visits were reviewed; DPPB cases were adjudicated by committee using a criterion-based lexicon. Multivariable logistic regression was performed, yielding adjusted odds ratios (AORs) for the association between clipping and DPPB. Secondary analyses were performed on procedures where one polyp was removed, in addition to propensity score-matched and subgroup analyses. RESULTS: In total, 8,366 colonoscopies involving polypectomy were analyzed, yielding 95 DPPB events. Prophylactic clipping was not associated with reduced DPPB (AOR 1.27; 0.83-1.96). These findings were similar in the single-polyp cohort (n = 3,369, AOR 1.07; 0.50-2.31). In patients with one proximal polyp ≥20 mm removed, there was a nonsignificant AOR with clipping of 0.55 (0.10-2.66). Clipping was not associated with a protective benefit in the propensity score-matched or other subgroup analyses. DISCUSSION: In this large cohort study, prophylactic clipping was not associated with lower DPPB rates. Endoscopists should not routinely use prophylactic clipping in most patients. Additional effectiveness and cost-effectiveness studies are required in patients with proximal lesions ≥20 mm, in whom there may be a role for prophylactic clipping.

Efficacy, safety, and tolerability of a ready-to-drink bowel preparation: subanalysis by age from a phase III, assessor-blinded study.

BACKGROUND: The incidence and mortality of colorectal cancer (CRC) increase with age and, therefore, it is recommended that adults undergo regular CRC screening, ideally by colonoscopy, with some new guidelines recommending screening begin at 45 years. Effective bowel preparation is a critical step to a successful colonoscopy. Of concern is that older adults may have poorer quality of bowel preparation or reduced tolerability for the bowel preparation. Here, we performed a post hoc secondary analysis for the effect of age on the efficacy, tolerability, and safety of ready-to-drink sodium picosulfate, magnesium oxide, and citric acid (SPMC oral solution) bowel preparation. METHODS: A phase III, randomized, assessor-blinded, multicenter, non-inferiority study was conducted comparing split-dose, low-volume SPMC oral solution with split-dose, low-volume sodium picosulfate, magnesium oxide, and citric acid powder for oral solution. A post hoc secondary analysis was performed to assess efficacy, safety, and tolerability of SPMC oral solution by age group (<50 years, 50-64 years, ⩾65 years). The prespecified primary efficacy endpoint ('responders') was the proportion of participants with 'excellent' or 'good' ratings on a modified Aronchick Scale (AS). Secondary efficacy outcomes were the quality of cleansing of the right colon as assessed by the Boston Bowel Preparation Scale (BBPS); as well as selected findings from the Mayo Clinic Bowel Prep Tolerability Questionnaire. Safety assessments included adverse events (AEs) and laboratory evaluations. RESULTS: Within age groups, at least 83.9% of participants were responders by the AS, and at least 91.1% of participants were responders by the BBPS in the right colon. On both scales, responder rates were highest in the youngest age group and decreased with increasing age. Greater than 88% of participants in any age group found the preparation 'easy' or 'acceptable' to ingest, with rates of 'easy' being highest in the oldest age group. No new safety signals were seen in any age group. The most commonly reported drug-related, treatment-emergent AEs were, by ascending age group, nausea (7.0%, 3.2%, 0.8%), headache (4.2%, 2.8%, 1.6%) and vomiting (2.8%, 1.2%, 0.8%). CONCLUSION: Ready-to-drink SPMC oral solution showed good efficacy of overall colon cleansing and tolerability in adults across different age groups, including those ⩾65 years.ClinicalTrials.gov identifier: NCT03017235.

Efficacy and safety of a ready-to-drink bowel preparation for colonoscopy: a randomized, controlled, non-inferiority trial.

BACKGROUND: We performed a randomized, controlled, assessor-blinded, multicenter, non-inferiority (NI) study to compare the safety and efficacy of a ready-to-drink formulation of sodium picosulfate, magnesium oxide, and citric acid (SPMC oral solution) with a powder formulation (P/MC powder) for oral solution. METHODS: Eligible participants (adults undergoing elective colonoscopy) were randomized 1:1 to split-dose SPMC oral solution or P/MC powder. The primary efficacy endpoint assessed overall colon-cleansing quality with the Aronchick Scale (AS), and the key secondary efficacy endpoint rated quality of right colon cleansing with the Boston Bowel Preparation Scale (BBPS). Assessments were performed by a treatment-blinded endoscopist. Tolerability was assessed using the Mayo Clinic Bowel Prep Tolerability Questionnaire. Safety assessments included adverse events and laboratory evaluations. RESULTS: The study included 901 participants: 448 for SPMC oral solution; 453 for P/MC powder. SPMC oral solution demonstrated non-inferiority to P/MC powder {87.7% (393/448) responders versus 81.5% (369/453) responders [difference (95% confidence interval): 6.3% (1.8, 10.9)]}. The key secondary efficacy objective assessing the right colon was also met. According to the prespecified hierarchical testing, after meeting the primary and key secondary objectives, SPMC oral solution was tested for superiority to P/MC powder for the primary endpoint (p = 0.0067). SPMC oral solution was well tolerated. Most common adverse events were nausea (3.1% versus 2.9%), headache (2.7% versus 3.1%), hypermagnesemia (2.0% versus 5.1%), and vomiting (1.3% versus 0.7%) for SPMC oral solution and P/MC powder, respectively. CONCLUSIONS: Ready-to-drink SPMC oral solution showed superior efficacy of overall colon cleansing compared with P/MC powder, with similar safety and tolerability.[ClinicalTrials.gov identifier: NCT03017235.].