Prognostic factors associated with upper gastrointestinal bleeding based on the French multicenter SANGHRIA trial.

Background and study aims Prognostic and risk factors for upper gastrointestinal bleeding (UGIB) might have changed overtime because of the increased use of direct oral anticoagulants and improved gastroenterological care. This study was undertaken to assess the outcomes of UGIB in light of these new determinants by establishing a new national, multicenter cohort 10 years after the first. Methods Consecutive outpatients and inpatients with UGIB symptoms consulting at 46 French general hospitals were prospectively included between November 2017 and October 2018. They were followed for at least for 6 weeks to assess 6-week rebleeding and mortality rates and factors associated with each event. Results Among the 2498 enrolled patients (mean age 68.5 [16.3] years, 67.1 % men), 74.5 % were outpatients and 21 % had cirrhosis. Median Charlson score was 2 (IQR 1-4) and Rockall score was 5 (IQR 3-6). Within 24 hours, 83.4 % of the patients underwent endoscopy. The main causes of bleeding were peptic ulcers (44.9 %) and portal hypertension (18.9 %). The early in-hospital rebleeding rate was 10.5 %. The 6-week mortality rate was 12.5 %. Predictors significantly associated with 6-week mortality were initial transfusion (OR 1.54; 95 %CI 1.04-2.28), Charlson score > 4 (OR 1.80; 95 %CI 1.31-2.48), Rockall score > 5 (OR 1.98; 95 %CI 1.39-2.80), being an inpatient (OR 2.45; 95 %CI 1.76-3.41) and rebleeding (OR 2.6; 95 %CI 1.85-3.64). Anticoagulant therapy was not associated with dreaded outcomes. Conclusions The 6-week mortality rate remained high after UGIB, especially for inpatients. Predictors of mortality underlined the weight of comorbidities on outcomes.

Colorectal polypectomy and endoscopic mucosal resection (EMR): European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline.

1 ESGE recommends cold snare polypectomy (CSP) as the preferred technique for removal of diminutive polyps (size ≤ 5 mm). This technique has high rates of complete resection, adequate tissue sampling for histology, and low complication rates. (High quality evidence, strong recommendation.) 2 ESGE suggests CSP for sessile polyps 6 - 9 mm in size because of its superior safety profile, although evidence comparing efficacy with hot snare polypectomy (HSP) is lacking. (Moderate quality evidence, weak recommendation.) 3 ESGE suggests HSP (with or without submucosal injection) for removal of sessile polyps 10 - 19 mm in size. In most cases deep thermal injury is a potential risk and thus submucosal injection prior to HSP should be considered. (Low quality evidence, strong recommendation.) 4 ESGE recommends HSP for pedunculated polyps. To prevent bleeding in pedunculated colorectal polyps with head ≥ 20 mm or a stalk ≥ 10 mm in diameter, ESGE recommends pretreatment of the stalk with injection of dilute adrenaline and/or mechanical hemostasis. (Moderate quality evidence, strong recommendation.) 5 ESGE recommends that the goals of endoscopic mucosal resection (EMR) are to achieve a completely snare-resected lesion in the safest minimum number of pieces, with adequate margins and without need for adjunctive ablative techniques. (Low quality evidence; strong recommendation.) 6 ESGE recommends careful lesion assessment prior to EMR to identify features suggestive of poor outcome. Features associated with incomplete resection or recurrence include lesion size > 40 mm, ileocecal valve location, prior failed attempts at resection, and size, morphology, site, and access (SMSA) level 4. (Moderate quality evidence; strong recommendation.) 7 For intraprocedural bleeding, ESGE recommends endoscopic coagulation (snare-tip soft coagulation or coagulating forceps) or mechanical therapy, with or without the combined use of dilute adrenaline injection. (Low quality evidence, strong recommendation.)An algorithm of polypectomy recommendations according to shape and size of polyps is given (Fig. 1).

Advanced imaging for detection and differentiation of colorectal neoplasia: European Society of Gastrointestinal Endoscopy (ESGE) Guideline.

MAIN RECOMMENDATIONS: 1 ESGE suggests the routine use of high definition white-light endoscopy systems for detecting colorectal neoplasia in average risk populations (weak recommendation, moderate quality evidence). 2 ESGE recommends the routine use of high definition systems and pancolonic conventional or virtual (narrow band imaging [NBI], i-SCAN) chromoendoscopy in patients with known or suspected Lynch syndrome (strong recommendation, low quality evidence). 2b ESGE recommends the routine use of high definition systems and pancolonic conventional or virtual (NBI) chromoendoscopy in patients with known or suspected serrated polyposis syndrome (strong recommendation, low quality evidence). 3 ESGE recommends the routine use of 0.1 % methylene blue or 0.1 % - 0.5 % indigo carmine pancolonic chromoendoscopy with targeted biopsies for neoplasia surveillance in patients with long-standing colitis. In appropriately trained hands, in the situation of quiescent disease activity and adequate bowel preparation, nontargeted, four-quadrant biopsies can be abandoned (strong recommendation, high quality evidence). 4 ESGE suggests that virtual chromoendoscopy (NBI, FICE, i-SCAN) and conventional chromoendoscopy can be used, under strictly controlled conditions, for real-time optical diagnosis of diminutive (≤ 5 mm) colorectal polyps to replace histopathological diagnosis. The optical diagnosis has to be reported using validated scales, must be adequately photodocumented, and can be performed only by experienced endoscopists who are adequately trained and audited (weak recommendation, high quality evidence). 5 ESGE suggests the use of conventional or virtual (NBI) magnified chromoendoscopy to predict the risk of invasive cancer and deep submucosal invasion in lesions such as those with a depressed component (0-IIc according to the Paris classification) or nongranular or mixed-type laterally spreading tumors (weak recommendation, moderate quality evidence). CONCLUSION: Advanced imaging techniques will need to be applied in specific patient groups in routine clinical practice and to be taught in endoscopic training programs.

The influence of waiting times on cost-effectiveness: a case study of colorectal cancer mass screening.

When a cost-effectiveness analysis is implemented, the health-care system is usually assumed to adjust smoothly to the proposed new strategy. However, technological innovations in health care may often induce friction in the organization of care supply, implying the congestion of services and subsequent waiting times. Our objective here is to measure how these short run rigidities can challenge cost-effectiveness recommendations favorable to an innovative mass screening test for colorectal cancer. Using Markov modeling, we compare the standard Guaiac fecal occult blood test (gFOBT) with an innovative screening test for colorectal cancer, namely the immunological fecal occult blood test (iFOBT). Waiting time can occur between a positive screening test and the subsequent confirmation colonoscopy. Five scenarios are considered for iFOBT: no further waiting time compared with gFOBT, twice as much waiting time for a period of 5 or 10 years, and twice as much waiting time for a period of 5 or 10 years combined with a 25% decrease in participation to confirmation colonoscopies. According to our modeling, compared with gFOBT, iFOBT would approximately double colonoscopy demand. Probabilistic sensitivity analysis enables concluding that the waiting time significantly increases the uncertainty surrounding recommendations favorable to iFOBT if it induces a decrease in the adherence rate for confirmation colonoscopy.

Factors associated with adenoma detection rate and diagnosis of polyps and colorectal cancer during colonoscopy in France: results of a prospective, nationwide survey.

INTRODUCTION: Colonoscopy can prevent deaths due to colorectal cancer (CRC) through early diagnosis or resection of colonic adenomas. We conducted a prospective, nationwide study on colonoscopy practice in France. METHODS: An online questionnaire was administered to 2,600 French gastroenterologists. Data from all consecutive colonoscopies performed during one week were collected. A statistical extrapolation of the results to a whole year was performed, and factors potentially associated with the adenoma detection rate (ADR) or the diagnosis of polyps or cancer were assessed. RESULTS: A total of 342 gastroenterologists, representative of the overall population of French gastroenterologists, provided data on 3,266 colonoscopies, corresponding to 1,200,529 (95% CI: 1,125,936-1,275,122) procedures for the year 2011. The indication for colonoscopy was CRC screening and digestive symptoms in 49.6% and 38.9% of cases, respectively. Polypectomy was performed in 35.5% of cases. The ADR and prevalence of CRC were 17.7% and 2.9%, respectively. The main factors associated with a high ADR were male gender (p=0.0001), age over 50 (p=0.0001), personal or family history of CRC or colorectal polyps (p<0.0001 and p<0.0001, respectively), and positive fecal occult blood test (p=0.0005). The prevalence of CRC was three times higher in patients with their first colonoscopy (4.2% vs. 1.4%; p<0.0001). CONCLUSIONS: For the first time in France, we report nationwide prospective data on colonoscopy practice, including histological results. We found an average ADR of 17.7%, and observed reduced CRC incidence in patients with previous colonoscopy.

A low-volume polyethylene glycol plus ascorbate solution for bowel cleansing prior to colonoscopy: the NORMO randomised clinical trial.

BACKGROUND: Patient acceptability of the preparation is a key factor in the success of colonoscopy, yet standard polyethylene glycol solutions are poorly tolerated owing to their high volume (4L) and low palatability. This study compared the efficacy, safety and acceptability of a 2L polyethylene glycol+ascorbate solution with a standard 4-L polyethylene glycol solution. METHODS: Adults referred for colonoscopy were randomised to 2-L polyethylene glycol+ascorbate (n=202) or 4-L polyethylene glycol solution (n=198). Colon cleansing success was assessed using the Harefield Cleansing Scale(©) and the Aronchick scale. Safety and acceptability were also assessed. RESULTS: Successful cleansing was achieved in 94.1% and 90.9% of subjects with the 2-L and 4-L solutions respectively using the Harefield Cleansing Scale(©) and 94.6% and 90.0% using the Aronchick scale (non significant). Despite better acceptability and tolerability, no superiority over the standard 4-L preparation was demonstrated. Fewer treatment-related adverse events were reported with the 2-L solution (80.2% versus 89.9%, p=0.011). More subjects were willing to take the 2L PEG+ascorbate solution again (87% versus 51%, p<0.001), found it easier to drink (80% versus 70%, p=0.025), with a better taste (p=0.01). CONCLUSIONS: Two-litre polyethylene glycol+ascorbate solution, with a similar high degree of cleansing and superior acceptability and tolerability, presents an alternative to 4-L polyethylene glycol when compliance is an issue.

Consensus guidelines for the use of bowel preparation prior to colonic diagnostic procedures: colonoscopy and small bowel video capsule endoscopy.

BACKGROUND: Adequate bowel preparation prior to colonic diagnostic procedures is essential to ensure adequate visualisation. SCOPE: This consensus aims to provide guidance as to the appropriate use of bowel preparation for a range of defined clinical circumstances. A consensus group from across Europe was convened and met to discuss appropriate bowel preparation. The use of polyethylene glycol (PEG), sodium picosulphate and sodium phosphate (NaP), together with other agents, prokinetics and simethicone, in colonoscopy and small bowel video capsule endoscopy were considered. A systematic review of the literature was carried out and additional unpublished data was obtained from the members of the consensus group where required. Recommendations were graded according to the level of evidence. FINDINGS: PEG-based regimens are recommended first line for both procedures, since their use is supported by good efficacy and safety data. Sodium-picosulphate-based regimens are recommended second line as their cleansing efficacy appears less than PEG-based regimens. NaP is not recommended for bowel cleansing due to the potential for renal damage and other adverse events. However, the use of NaP is acceptable in patients in whom PEG or sodium picosulphate is ineffective or not tolerated. NaP should not be used in patients with chronic kidney disease, pre-existing electrolyte disturbances, congestive heart failure, cirrhosis or a history of hypertension. The timing of the dose, dietary restrictions, use in special patient groups and recording of the quality of bowel preparation are also considered for patients undergoing colonoscopy. During the development of the guidelines the European Society of Gastrointestinal Endoscopy (ESGE) issued guidance on bowel preparation for colonoscopy. The ESGE guidelines and these consensus guidelines share many recommendations; differences between the guidelines are reviewed. CONCLUSION: The use of bowel preparation should be tailored to the individual patient and their specific clinical circumstances.

Validation of the Harefield Cleansing Scale: a tool for the evaluation of bowel cleansing quality in both research and clinical practice.

BACKGROUND: Variations in bowel cleansing quality before colonoscopy can cause confounding of results within clinical trials and inappropriate treatment decisions in clinical practice. A new tool-the Harefield Cleaning Scale-has been developed, which addresses the limitations of existing scales. OBJECTIVE: Validation exercise for the new cleansing scale. DESIGN: Retrospective validation study. SETTING: Various colonoscopy units in France. PATIENTS: Patients who had a total of 337 colonoscopies recorded. INTERVENTION: Video-recorded colonoscopy. MAIN OUTCOME MEASUREMENTS: Comparisons of 2 scoring systems to assess direct correlation, interrater reliability, internal consistency, and test-retest reliability, based on assessment of video recordings from 337 colonoscopies. RESULTS: Correlation analysis for expert scores by using the 2 scales yielded a Spearman correlation coefficient of 0.833. Similarly, the comparison of the segmental sum score revealed a Spearman correlation coefficient of -0.778. Cross-tabulation for successful colon cleansing was 92.88% versus unsuccessful colon cleansing in 7.12%. Reliability assessment indicated an acceptable internal consistency with a Cronbach alpha coefficient of 0.81. Test-retest reliability demonstrated an overall agreement of 0.639 (kappa statistic). Receiver operating characteristic analysis versus Aronchick Scale scores yielded an area under the curve of 0.945, with sensitivity of 99% and specificity of 83% at the optimum score cut-off point. LIMITATIONS: Test-retest reliability was assessed by using a different patient population to the other measures. There were insufficient patient numbers to assess performance by using adenoma detection rate. CONCLUSION: This validation analysis has demonstrated that the Harefield Cleansing Scale is a robust, reliable, and consistent tool that has the potential to improve the effective standardization of bowel preparation assessment in both clinical and research practice.

Comparison of a standard fully covered stent with a super-thick silicone-covered stent for the treatment of refractory esophageal benign strictures: A prospective multicenter study.

BACKGROUND: Some esophageal strictures resist endoscopic treatments. There is a need for new treatments, such as specifically designed stents. OBJECTIVE: Our study sought to compare the results achieved with a standard, fully covered metallic stent (FCMS) and those achieved using a stent designed specifically for benign strictures (BS-FCMS). PATIENTS AND METHODS: The study used a prospective, multicenter, controlled design, with patients recruited from tertiary referral centers. Patients with refractory esophageal strictures were included. Standard FCMS were used in group 1 (N = 24), and BS-FCMS were used in group 2 (N = 17). Patients were followed for 24 months after stent removal. The main outcomes measured were stricture resolution rate, 24 months' recurrence rate and stent-related morbidity. RESULTS: Early stent migrations occurred in one (4.1%) patient from group 1 and five (29.4%) from group 2 (p < 0.05). During esophageal stenting, complications occurred in six patients (25%) in group 1 and six patients (35.3%) in group 2 (p = 0.47), respectively. Fifty percent of complications were attributed to migration. There was no procedure-related morbidity associated with the extraction of the stent. The stricture resolution rate was, respectively, 95.2% in group 1 and 87.5% in group 2 (the difference between the two groups is not significant). During follow-up, stricture recurrence occurred in 15/19 patients (group 1, 79%) and 7/8 patients (group 2, 87.5%; p = 1.0). The median time to recurrence of esophageal stricture was 1.7 months (group 1, 0.6-12 months) and 1 month (group 2, 0.1-6 months). Study limitations include its nonrandomized design. CONCLUSION: The stricture resolution rate was high at the end of the stenting period for both types of stents without any statistical difference between the two groups, but the long-term results were disappointing, with stricture recurring frequently and rapidly in both groups.

Incremental net benefit and acceptability of alternative health policies: a case study of mass screening for colorectal cancer.

The incremental net benefit (INB) and the related acceptability curves for public health programs provide valuable tools for decision making. We proposed to apply them to the assessment of mass screening of colorectal cancer. The now standard guaiac fecal occult blood test (FOBT) is already implemented in several countries. We considered the innovative immunological FOBT and computed tomography colonography (CTC) as competing screening technologies. Using biennial guaiac FOBT as the reference strategy, we estimated the cost-effectiveness of the following alternatives: biennial immunological FOBT, CTC every 5 years (strategy CTC5), and CTC every 10 years (strategy CTC10). Over a 30-year horizon and from the perspective of a third-party payer, we developed a Markov model on a hypothetical cohort of 100,000 subjects at average risk of colorectal cancer. Close expected net benefits between immunological FOBT and CTC5 induced uncertainty in the choice of the optimal strategy. Probabilistic sensibility analysis then suggested that below a willingness to pay (WTP) per life-years gained (LYG) of 8,587 €/LYG, CTC10 was optimal, while CTC5 would be preferred beyond a WTP of 8,587 €/LYG.

Cost-effectiveness of colorectal cancer screening with computed tomography colonography or fecal blood tests.

OBJECTIVE: To assess the cost-effectiveness of colorectal cancer screening using computed tomography colonography (CTC) and immunological fecal occult blood test (iFOBT). METHODS: CTC and iFOBT strategies were compared with Nn screening or guaiac FOBT (gFOBT) using Markov modeling. CTC was proposed at 50, 60, and 70 years, whereas gFOBT and iFOBT were performed every 2 years beginning at 50 years until 74 years of age with a 30-year time horizon. We calculated incremental cost-effectiveness ratios and efficiency ratios (ERs). Then, we performed univariate and probabilistic sensitivity analyses. RESULTS: With gFOBT as reference, colorectal cancer prevention rate was 18% for CTC and 11% for iFOBT. The incremental cost-effectiveness ratio of CTC and iFOBT were respectively 3204 and 5458 euro per life years gained (LYG), the ER for CTC was 0.22 and the ER for iFOBT was 2.08 colonoscopies per LYG. Cost-effectiveness results were sensitive to CTC cost. In the probabilistic sensitivity analysis, compared with CTC, iFOBT strategy was cost-effective for 84.6% of simulations when we assumed a willingness to pay (WTP) of 20,000 euro/LYG. CONCLUSION: CTC requires substantially less colonoscopies than iFOBT and is cost-effective for low values of WTP. However, iFOBT is the preferred screening strategy for a WTP greater than 6207 euro/LYG.

Cost-effectiveness of colorectal cancer screening with computed tomography colonography according to a polyp size threshold for polypectomy.

OBJECTIVE: Computed tomography colonography (CTC) has an acceptable accuracy in detecting colonic lesions, especially for polyps at least 6 mm. The aim of this analysis is to determine the cost-effectiveness of population-based screening for colorectal cancer (CRC) using CTC with a polyp size threshold. METHODS: The cost-effectiveness ratios of CTC performed at 50, 60 and 70 years old, without (PL strategy) or with (TS strategy) polyp size threshold were compared using a Markov process. Incremental cost-effectiveness ratios (ICER) were calculated per life-years gained (LYG) for a time horizon of 30 years. RESULTS: The ICER of PL and TS strategies were 12 042 and 2765 euro/LYG associated to CRC prevention rates of 37.9 and 36.5%. The ICER of PL and TS strategies dropped to 9687 and 1857 euro/LYG when advanced adenoma (AA) prevalence increased from 6.9 to 8.6% for male participants and 3.8-4.9% for female participants or to 9482 and 2067 euro/LYG when adenoma and AA annual recurrence rates dropped to 3.2 and 0.25%. The ICER for PL and TS strategies decreased to 7947 and 954 euro/LYG or when only two CTC were performed at 50 and 60-years-old. Conversely, the ICER did not significantly change when varying population participation rate or accuracy of CTC. CONCLUSION: CTC with a 6 mm threshold for polypectomy is associated to a substantial cost reduction without significant loss of efficacy. Cost-effectiveness depends more on the AA prevalence or transition rate to CRC than on CTC accuracy or screening compliance.

Assessment of water enema computed tomography: an effective imaging technique for the diagnosis of colon cancer: Colon cancer: computed tomography using a water enema.

AIM: The aim of this study was to assess the accuracy of water enema computed tomography (WECT) for the diagnosis of colon cancer. METHODS: A total of 191 patients referred for clinically suspected colon cancer were prospectively evaluated by WECT in a multicenter trial. Examination was contrast enhanced helical CT after colon filling through a rectal tube. For all the cases, final diagnosis was obtained by colonoscopy and/or surgery. CT data were interpreted both locally and at a centralized site by a specialized and general radiologist. RESULTS: Seventy-one patients were diagnosed with colon cancer. Overall, WECT sensitivity and specificity were 98.6 and 95.0%, respectively. Positive and negative predictive values were 92.1 and 99.1%, respectively. In a subgroup of 33 patients with unclean bowel, the sensitivity and specificity of WECT were 95.0 and 92.3%, respectively. The correlation between local radiologists and the specialized radiologist was excellent (Kappa = 0.87) as was the correlation between the general radiologist and the specialist (Kappa = 0.92). CONCLUSION: This prospective analysis demonstrates that WECT is an effective, safe, and simple imaging technique for the diagnosis of colon cancer and can be proposed when a strong clinical suspicion of colon cancer is present, especially in frail patients.

Capsule endoscopy and bowel preparation with oral sodium phosphate: a prospective randomized controlled trial.

BACKGROUND: Capsule endoscopy (CE) is the first procedure to explore the small bowel in obscure GI bleeding (OGB). OBJECTIVE: To evaluate the role of bowel preparation with oral sodium phosphate (NaP) in this indication. DESIGN: A prospective multicenter, controlled, randomized, blind study. METHODS: A total of 129 patients with the diagnosis of OGB were included and were randomized into 2 groups (group A [n = 64] and group B [n = 63]). In group A, a CE was performed after an 8-hour fasting period. In group B, patients were asked to drink 2 doses of 45 mL NaP before swallowing the capsule. The quality of the images was assessed at 5 different locations of the small bowel. Bowel cleanliness and visibility were evaluated by using 2 scoring systems, which included assessing the presence of bubbles, liquid, and the rate of visibility. RESULTS: A total of 127 patients (53 men; mean age 56.9 years, range 19-90 years) were analyzed for the preparation and detection of lesions (2 patients were not able to swallow the capsule). No difference was observed for cleanliness and visibility between the 2 groups at any of the small-bowel segments; no difference was found for gastric transit time (39.8 minutes vs 35.7 minutes, P = .63), small-bowel transit time (257.5 minutes vs 248.6 minutes, P = .59), and the detection of lesions (35.9% vs 42.8%, P = .54). LIMITATIONS: The evaluation of bowel cleanliness was based on subjective features. CONCLUSIONS: The results of the present study, despite a significant number of limitations, did not support that small-bowel preparation with oral NaP can be recommended for CE exploration in patients with OGB.