Evaluation of Clensia®, a new low-volume PEG bowel preparation in colonoscopy: Multicentre randomized controlled trial versus 4L PEG.

BACKGROUND: Success of colonoscopy is linked to the adequacy of bowel cleansing. Polyethylene glycol 4L (PEG 4L) solutions are widely used for colonic cleansing but with limitations concerning tolerability and acceptability. AIM: To demonstrate the equivalence of a new low-volume PEG containing citrates and simeticone (Clensia) versus a standard PEG 4L. METHODS: In this, multicentre, randomised, observer-blind trial, patients received either Clensia 2L or PEG 4L solution. Primary endpoint was the proportion of patients with colon cleansing evaluated as excellent or good. RESULTS: 422 patients received Clensia (n=213) or PEG 4L (n=209). Rate of excellent/good bowel cleansing was 73.6% and 72.3% in Clensia and PEG 4L group respectively. Clensia was demonstrated to be equivalent to PEG 4L. No SAEs were observed. Clensia showed better gastrointestinal tolerability (37.0% vs 25.4%). The acceptability was significantly better with Clensia in terms of proportion of subjects who felt no distress (Clensia 72.8% vs PEG 4L 63%, P=0.0314) and willingness-to-repeat (93.9% vs 82.2%, P=0.0002). The rate of optimal compliance was similar with both formulations (91.1% for Clensia vs 90.9% for PEG 4L, P=0.9388). CONCLUSIONS: The low-volume Clensia is equally effective and safe in bowel cleansing compared to the standard PEG 4L, with better gastrointestinal tolerability and acceptability.

Predictive value of the Diverticular Inflammation and Complication Assessment (DICA) endoscopic classification on the outcome of diverticular disease of the colon: An international study.

BACKGROUND: Diverticular Inflammation and Complication Assessment (DICA) endoscopic classification has been recently developed for patients suffering from diverticulosis and diverticular disease. AIMS: We assessed retrospectively the predictive value of DICA in patients for whom endoscopic data and clinical follow-up were available. METHODS: For each patient, we recorded: age, severity of DICA, presence of abdominal pain, C-reactive protein and faecal calprotectin test (if available) at the time of diagnosis; months of follow-up; therapy taken during the follow-up to maintain remission (if any); occurrence/recurrence of diverticulitis; need of surgery. RESULTS: We enrolled 1651 patients (793 M, 858 F, mean age 66.6 ± 11.1 years): 939 (56.9%) patients were classified as DICA 1, 501 (30.3%) patients as DICA 2 and 211 (12.8%) patients as DICA 3. The median follow-up was 24 (9-38) months. Acute diverticulitis (AD) occurred/recurred in 263 (15.9%) patients; surgery was necessary in 57 (21.7%) cases. DICA was the only factor significantly associated to the occurrence/recurrence of diverticulitis and surgery either at univariate (χ(2 )= 405.029; p < 0.0001) or multivariate analysis (hazard ratio = 4.319, 95% confidence interval (CI) 3.639-5.126; p < 0.0001). Only in DICA 2 patients was therapy effective for prevention of AD occurrence/recurrence with a hazard ratio (95% CI) of 0.598 (0.391-0.914) (p = 0.006, log rank test). Mesalazine-based therapies reduced the risk of AD occurrence/recurrence and needs of surgery with a hazard ratio (95% CI) of 0.2103 (0.122-0.364) and 0.459 (0.258-0.818), respectively. CONCLUSIONS: DICA classification is a valid parameter to predict the risk of diverticulitis occurrence/recurrence in patients suffering from diverticular disease of the colon.

Endoscopic resection for superficial colorectal neoplasia in Italy: a prospective multicentre study.

BACKGROUND: Since there are few prospective studies on colorectal endoscopic resection to date, we aimed to prospectively assess safety and efficacy of endoscopic resection in a cohort of Italian patients. METHODS: Prospective multicentre assessment of resection of sessile polyps or non-polypoid lesions ≥10mm in size or smaller (if depressed). Outcome measures included complete excision, morbidity, mortality, and residual/recurrence at 12 months. RESULTS: Overall, 1012 resections in 928 patients were analysed (62.4% sessile polyps, 28.8% laterally spreading tumours, 8.7% depressed non-polypoid lesions). Lesions were prevalent in the proximal colon. En bloc resection was possible in 715/1012 cases (70.7%), whereas piecemeal resection was required in 297 (29.3%). Endoscopically complete excision was achieved in 866 cases (85.6%). Adverse events occurred in 83 (8.2%), and no deaths occurred. Independent predictors of 12-month residual/recurrence were the location of the lesion in the proximal colon (OR 2.22 [95% CI 1.16-4.26]; p=0.015) and piecemeal endoscopic resection (OR 2.76 [95% CI 1.56-4.87]; p=0.0005). Limitations of the study were: potential expertise bias, no data on eligible and potentially resectable excluded lesions, high percentage of lesions<20mm, follow-up limited to 1 year. CONCLUSION: In this registry study the endoscopic resection of colorectal lesions was safe and achieved high rates of long-term endoscopic clearance.

Upper GI endoscopy in elderly patients: predictive factors of relevant endoscopic findings.

Elderly patients are at increased risk for peptic ulcer and cancer. Predictive factors of relevant endoscopic findings at upper endoscopy in the elderly are unknown. This was a post hoc analysis of a nationwide, endoscopic study. A total of 3,147 elderly patients were selected. Demographic, clinical, and endoscopic data were systematically collected. Relevant findings and new diagnoses of peptic ulcer and malignancy were computed. Both univariate and multivariate analyses were performed. A total of 1,559 (49.5%), 213 (6.8%), 93 (3%) relevant findings, peptic ulcers, and malignancies were detected. Peptic ulcers and malignancies were more frequent in >85-year-old patients (OR 3.1, 95% CI = 2.0-4.7, p = 0.001). The presence of dysphagia (OR = 5.15), weight loss (OR = 4.77), persistent vomiting (OR = 3.68), anaemia (OR = 1.83), and male gender (OR = 1.9) were significantly associated with a malignancy, whilst overt bleeding (OR = 6.66), NSAIDs use (OR = 2.23), and epigastric pain (OR = 1.90) were associated with the presence of peptic ulcer. Peptic ulcer or malignancies were detected in 10% of elderly patients, supporting the use of endoscopy in this age group. Very elderly patients appear to be at higher risk of such lesions.

Predicting mortality in non-variceal upper gastrointestinal bleeders: validation of the Italian PNED Score and Prospective Comparison with the Rockall Score.

OBJECTIVES: We sought (i) to validate a new prediction rule of mortality (Progetto Nazionale Emorragia Digestiva (PNED) score) on an independent population with non-variceal upper gastrointestinal bleeding (UGIB) and (ii) to compare the accuracy of the Italian PNED score vs. the Rockall score in predicting the risk of death. METHODS: We conducted prospective validation of analysis of consecutive patients with UGIB at 21 hospitals from 2007 to 2008. Outcome measure was 30-day mortality. All the variables used to calculate the Rockall score as well as those identified in the Italian predictive model were considered. Calibration of the model was tested using the chi2 goodness-of-fit and performance characteristics with receiver operating characteristic (ROC) analysis. The area under the ROC curve (AUC) was used to quantify the diagnostic accuracy of the two predictive models. RESULTS: Over a 16-month period, data on 1,360 patients were entered in a national database and analyzed. Peptic ulcer bleeding was recorded in 60.7% of cases. One or more comorbidities were present in 66% of patients. Endoscopic treatment was delivered in all high-risk patients followed by high-dose intravenous proton pump inhibitor in 95% of them. Sixty-six patients died (mortality 4.85%; 3.54-5.75). The PNED score showed a high discriminant capability and was significantly superior to the Rockall score in predicting the risk of death (AUC 0.81 (0.72-0.90) vs. 0.66 (0.60-0.72), P<0.000). Positive likelihood ratio for mortality in patients with a PNED risk score >8 was 16.05. CONCLUSIONS: The Italian 10-point score for the prediction of death was successfully validated in this independent population of patients with non-variceal gastrointestinal bleeding. The PNED score is accurate and superior to the Rockall score. Further external validation at the international level is needed.

Gastro-protective strategies in primary care in Italy: the "Gas.Pro." survey.

INTRODUCTION: Risk of gastrointestinal injury is relevant among users of anti-inflammatory or cardio-protective drugs. Adequate gastro-protection is warranted in high-risk patients. AIM: To assess the perceptions and practices of Italian primary care physicians regarding gastro-protective strategies. METHODS: Nationwide cross-sectional observational study. A 14-question survey questionnaire was administered to 112 primary care physicians throughout Italy. Data collection covered consecutive outpatient candidates for the prescription of a potentially GI harmful medication, observed in the physicians' office over a 3-week period. RESULTS: Cohort included 3943 cases (2489 naïve and 1463 chronic NSAID/ASA users). Mean age and prevalence of cardiovascular comorbidity were significantly higher in the latter subgroup. Non-selective NSAIDs and low-dose aspirin were the most commonly prescribed drugs. Combined NSAIDS/ASA plus steroids/anticoagulant/antiplatelets were recorded in 161 cases. Helicobacter pylori status was known in only 38% of naïve and 33.2% of chronic users, being negative in 85.3% and 89.5%, respectively. When positive, H. pylori was eradicated by almost all physicians (97.9%), but in case of unknown H. pylori status, the presence of infection was investigated in only 8.6% and 14.9% of patients in the two subgroups. Gastro-protection was endorsed in 80.7% of patients, mostly PPIs (91%). In patients aged over 70, pantoprazole and lansoprazole were the preferred gastro-protective agents. CONCLUSIONS: There is a significant over-use of gastro-protection in the primary care setting in Italy and the role H. pylori is largely overlooked. Educational efforts should be directed to a more targeted gastro-protection only for at-risk patients as well as improved adherence to recommendations for testing and treating H. pylori infection.

Can magnification endoscopy detect residual adenoma after piecemeal resection of large sessile colorectal lesions to guide subsequent treatment? A prospective single-center study.

PURPOSE: This study assesses the ability of magnification endoscopy to detect residual adenomatous tissue after endoscopic piecemeal resection of colorectal polyps and evaluates the impact of the technique on the incidence of recurrence. METHODS: Patients who underwent endoscopic piecemeal resection for large (>2 cm) sessile colorectal polyps were included. After endoscopic piecemeal resection, both the outer resection margins and the central severed area were inspected with magnification endoscopy. Completeness of excision as determined from the magnified surface pattern was compared with that determined histologically. Areas of incomplete resection were treated with additional resection or argon plasma coagulation. RESULTS: A total of 77 lesions were resected. Mean size of the resected lesions was 29 +/- 6 mm (range, 23-60). Complications of resection occurred in eight patients (seven had immediate bleeding that was successfully managed with hemoclip application, and one had delayed perforation that was treated surgically). The sensitivity of magnification endoscopy for predicting remnant adenoma at resection margins was 98% (95% confidence interval 90-100); specificity was 90% (95% confidence interval 79-100). Overall accuracy was 94.5% (95% confidence interval 87.2-98.6). On a mean follow-up of 32 months (range, 18-46) the recurrence rate was 2.6%. CONCLUSIONS: Magnification endoscopy is accurate at predicting remnant tissue after endoscopic piecemeal resection of large sessile colorectal polypoid lesions. When applied on both outer margins and inner portions of the severed area, it is helpful as a guide to subsequent further treatment to decrease recurrence.

Self-assembled hydro-jet system for submucosal elevation before endoscopic resection of nonpolypoid colorectal lesions (with video).

BACKGROUND: Endoscopic resection of colorectal nonpolypoid lesions requires adequate submucosal lifting of the lesion. OBJECTIVE: To evaluate a self-assembled hydro-jet system for tissue elevation to improve endoscopic resection of colorectal nonpolypoid lesions. DESIGN: Prospective study. SETTING: Single-center teaching hospital. MAIN OUTCOME MEASUREMENTS: Efficacy and safety of the hydro-jet system and rate of complete resection. RESULTS: The system was clinically applied in 31 patients to remove a total of 34 lesions throughout the colon. An adequate submucosal fluid cushion was achieved in all but 1 case without any lifting-associated complications. Complete endoscopic resection was possible in all 33 lifted lesions by using a snare. The size of the resected lesions ranged from 7 to 60 mm. Major intraprocedure bleeding occurred in only 1 case. No perforation or late bleeding was recorded. Histological examination showed a selective accumulation of fluid in the submucosa with edema and dissociation of submucosal structures, with no damage to the muscularis mucosa and very limited "burn effect" hampering assessment of radial margins. LIMITATIONS: Lack of controls. CONCLUSIONS: This inexpensive system allows safe and rapid submucosal lifting of colorectal nonpolypoid lesions to assist endoscopic resection.

Predictive factors of mortality from nonvariceal upper gastrointestinal hemorrhage: a multicenter study.

OBJECTIVES: From an Italian Registry of patients with upper gastrointestinal hemorrhage (UGIH), we assessed the clinical outcomes and explored the roles of clinical, endoscopic, and therapeutic factors on 30-day mortality in a real life setting. METHODS: Prospective analysis of consecutive patients endoscoped for UGIH at 23 community and tertiary care institutions from 2003 to 2004. Covariates and outcomes were defined a priori and 30-day follow-up obtained. Logistic regression analysis identified predictors of mortality. RESULTS: One thousand and twenty patients were included. A total of 46 patients died for an overall 4.5% mortality rate. In all, 85% of deaths were associated with one or more major comorbidity. Sixteen of 46 patients (35%) died within the first 24 h of the onset of bleeding. Of these, eight had been categorized as ASA class 1 or 2 and none of them was operated upon, despite a failure of endoscopic intention to treatment in four. Regression analysis showed advanced age, presence of severe comorbidity, low hemoglobin levels at presentation, and worsening health status as the only independent predictors of 30-day mortality (P < 0.001). The acute use of a PPI exerted a protective effect (OR 0.23, 95% CI 0.09-0.73). Recurrent bleeding was low (3.2%). Rebleeders accounted for only 11% of the total patients deceased (OR 3.27, 95% CI 1.5-11.2). CONCLUSIONS: These results indicate that 30-day mortality for nonvariceal bleeding is low. Deaths occurred predominantly in elderly patients with severe comorbidities or those with failure of endoscopic intention to treatment.

Dual therapy versus monotherapy in the endoscopic treatment of high-risk bleeding ulcers: a meta-analysis of controlled trials.

BACKGROUND: There is no definite recommendation on the use of dual endoscopic therapy in patients with severe peptic ulcer bleeding. A systematic review and meta-analysis were performed to determine whether the use of two endoscopic hemostatic procedures improved patient outcomes compared with monotherapy. METHODS: A search for randomized trials comparing dual therapy (i.e., epinephrine injection plus other injection or thermal or mechanical method) versus monotherapy (injection, thermal, or mechanical alone) was performed between 1990 and 2006. Heterogeneity between studies was tested with chi(2) and explained by metaregression analysis. RESULTS: Twenty studies (2,472 patients) met inclusion criteria. Compared with controls, dual endoscopic therapy reduces the risk of recurrent bleeding (OR [odds ratio] 0.59 [0.44-0.80], P= 0.0001) and the risk of emergency surgery (OR 0.66 [0.49-0.89], P= 0.03) and showed a trend toward a reduction in the risk of death (OR 0.68 [0.46-1.02], P= 0.06). Subcategory analysis showed that dual therapy was significantly superior to injection therapy alone for all the outcomes considered, but failed to demonstrate that any combination of treatments is better than either mechanical therapy alone (OR 1.04 [0.45-2.45] for rebleeding, 0.49 [0.50-4.87] for surgery, and 1.28 [0.34-4.86] for death) or thermal therapy alone (OR 0.67 [0.40-1.20] for rebleeding, 0.89 [0.45-1.76] for surgery, and 0.51 [0.24-1.10] for death). CONCLUSIONS: Dual endoscopic therapy proved significantly superior to epinephrine injection alone, but had no advantage over thermal or mechanical monotherapy in improving the outcome of patients with high-risk peptic ulcer bleeding.