Gianluca Rotondano

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 χ2 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.

Effective bowel cleansing before colonoscopy: a randomized study of split-dosage versus non-split dosage regimens of high-volume versus low-volume polyethylene glycol solutions

BACKGROUND Adequate bowel cleansing is essential for a high-quality, effective, and safe colonoscopy. OBJECTIVES To evaluate the degree of colon cleansing comparing split-dosage versus non-split-dosage intake of two different polyethylene glycol (PEG) volumes (low-volume PEG + ascorbic acid vs standard-volume PEG-electrolyte solution) and to identify predictors of poor bowel cleansing. DESIGN Single-blind, active control, randomized study. SETTING Tertiary-care institutions in Italy. PATIENTS This study involved adult patients undergoing elective colonoscopy. INTERVENTION Colonoscopy with different bowel preparation methods. MAIN OUTCOME MEASUREMENTS Degree of bowel cleansing. RESULTS We randomized 895 patients, and 868 patients were finally included in intention-to-treat (ITT) analysis. Overall compliance was excellent (97%) for both preparation methods. No difference in tolerability was recorded. Palatability was superior with low volume compared with high volume (acceptable or good 58% vs 51%, respectively, P < .005), independently of intake schedule. PEG plus ascorbic acid produced the same degree of cleansing as standard-volume PEG-electrolyte solution (77% vs 73.4%, respectively, within the split-dosage group and 41.7% vs 44.3%, respectively, within the non-split-dosage group). Independently of PEG volumes, the split-dosage regimen produced markedly superior cleansing results over the same-day method (good/excellent 327/435, 75.2% vs 186/433, 43.0%, P = .00001). Maximum cleansing was observed in colonoscopies performed within 8 hours from the last fluid intake versus over 8 hours from the last fluid intake (P < .001). The degree of bowel cleansing affected both cecal intubation (failed intubation 11.7% with fair/poor preparation vs 1.2% with good/excellent preparation, P = .00001) and polyp detection rates (12.2% with fair/poor vs 24.6% with good/excellent preparation, P = .001). Aborted procedures were significantly more frequent in the non-split-dosage arm (21.2% vs 6.9%, odds ratio [OR] 3.60 [2.29-5.77], P < .0001). Independent predictors of poor bowel cleansing were male sex (OR 1.45 [1.08-1.96], P = .014) and a non-split-dosage bowel preparation schedule (OR 2.08 [1.89-2.37], P = .0001). CONCLUSION Low-volume PEG plus ascorbic acid is as effective as high-volume PEG-electrolyte solution but has superior palatability. A split-dosage schedule is the most effective bowel cleansing method. Colonoscopy should be performed within 8 hours of the last fluid intake.

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.

Capsule Endoscopy Versus Enteroclysis in the Detection of Small-Bowel Involvement in Crohn’s Disease: A Prospective Trial

BACKGROUND & AIMS The aim of this study was to prospectively compare the diagnostic yield of wireless capsule endoscopy (WCE) and enteroclysis in evaluating the extent of small-bowel involvement in Crohns disease (CD). METHODS Thirty-one patients (20 men; mean age, 43 y) with endoscopically and histologically proven CD underwent enteroclysis as their initial examination, followed by WCE. The radiologist who performed the small-bowel enema was blinded to the results of standard index endoscopy, which included retrograde ileoscopy. Gastroenterologists were blinded to the results of enteroclysis at the time of interpretation of the WCE video. RESULTS Abnormal findings were documented in 8 of 31 patients by using enteroclysis and in 22 of 31 patients by using WCE (25.8% vs. 71%, P < .001). In 16 patients with known involvement of the terminal ileum, the diagnostic yield of WCE vs enteroclysis was significantly superior (89% vs 37%, P < .001). In 15 patients without lesions in the terminal ileum, abnormal findings in the proximal small bowel were detected in 7 (46%) patients by WCE and only in 2 (13%) patients by enteroclysis (P < .001). The capsule detected all but 2 lesions diagnosed by enteroclysis. WCE detected additional lesions that were not detected by enteroclysis in 45% of cases. CONCLUSIONS WCE is superior to enteroclysis in estimating the presence and extent of small-bowel CD. WCE may be a new gold standard for diagnosing ileal involvement in patients with CD without strictures and fistulae.

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 χ2 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.

Capsule enteroscopy vs. other diagnostic procedures in diagnosing obscure gastrointestinal bleeding: a cost-effectiveness study.

Background Capsule enteroscopy is considered the gold standard for evaluating patients with obscure gastrointestinal bleeding. The costs of capsule enteroscopy examination, however, make it uncertain whether the clinically relevant diagnostic gain is also associated with cost savings. Aim To evaluate the incremental cost–effectiveness ratio of capsule enteroscopy in patients with obscure gastrointestinal bleeding. Methods Retrospective study was carried out in nine Italian gastroenterology units from 2003 to 2005. Data on 369 consecutive patients with obscure gastrointestinal bleeding were collected. The diagnostic yield of capsule enteroscopy vs. other imaging procedures was evaluated as a measure of efficacy. The values of Diagnosis Related Group 175 (&U20AC;1884.00 for obscure-occult bleeding and &U20AC;2141.00 for obscure-overt bleeding) were calculated as measures of economic outcomes in the cost analysis. Results Obscure and occult gastrointestinal bleeding was recorded in 177 patients (48%) with a mean duration of anemia history of 17.6±20.7 months. Among patients, 60.9% had had at least one hospital admission, 21.2% at least two, and 1.2% of obscure bleeders up to nine admissions. Overall, 58.4% of patients had positive findings with capsule enteroscopy compared with 28.0% with other imaging procedures (P<0.001). The mean cost of a positive diagnosis with capsule enteroscopy was &U20AC;2090.76 and that of other procedures was &U20AC;3828.83 with a mean cost saving of &U20AC;1738.07 (P<0.001) for one positive diagnosis. Conclusions Capsule enteroscopy is a cost-saving approach in the evaluation of patients with obscure gastrointestinal bleeding.

Combined epinephrine and bipolar probe coagulation vs. bipolar probe coagulation alone for bleeding peptic ulcer: a randomized, controlled trial

BACKGROUND Endoscopic treatment with combined modalities is considered standard of care for patients with high-risk peptic ulcer bleeding. This study compared epinephrine injection plus bipolar probe coagulation with bipolar probe coagulation alone in patients with high-risk peptic ulcer bleeding. METHODS Patients with endoscopically confirmed peptic ulcer bleeding (active or visible vessel) seen from January 2000 through December 2002 were prospectively randomized to two groups. The study group (n = 58) had epinephrine injection followed by bipolar coagulation; the control group (n = 56) was treated by bipolar coagulation alone. The primary outcomes assessed were the rate of initial hemostasis and the rate of recurrent bleeding. Secondary outcomes were the following: need for surgical intervention to control bleeding, transfusion requirements, length of hospital stay (in days), and 30-day mortality. RESULTS The rate of initial hemostasis was significantly higher in the combination therapy group ( p = 0.02; absolute risk reduction 31.6%: 95% CI [5.4, 57.7]). There was no significant difference between the two treatment groups with respect to all other outcomes measures, except that significantly fewer units of blood were transfused in the combination therapy group ( p = 0.006). CONCLUSIONS In patients with active peptic ulcer bleeding, epinephrine injection plus bipolar coagulation achieved significantly higher rate of initial hemostasis. All other outcome measures were similar with either treatment in patients with non-bleeding stigmata.

Predicting mortality in patients with in-hospital nonvariceal upper GI bleeding: a prospective, multicenter database study

BACKGROUND Nonvariceal upper GI bleeding (NVUGIB) that occurs in patients already hospitalized for another condition is associated with increased mortality, but outcome predictors have not been consistently identified. OBJECTIVE To assess clinical outcomes of NVUGIB and identify predictors of mortality from NVUGIB in patients with in-hospital bleeding compared with outpatients. DESIGN Secondary analysis of prospectively collected data from 2 nationwide multicenter databases. Descriptive, inferential, and multivariate logistic regression models were carried out in 338 inpatients (68.6 ± 16.4 years of age, 68% male patients) and 1979 outpatients (67.8 ± 17 years of age, 66% male patients). A predictive model was constructed using the risk factors identified at multivariate analysis, weighted according to the contribution of each factor. SETTINGS A total of 23 Italian community and tertiary care centers. PATIENTS Consecutive patients admitted for acute NVUGIB. INTERVENTIONS Early endoscopy, medical and endoscopic treatment as appropriate. MAIN OUTCOME MEASUREMENTS Recurrent bleeding, surgery, and 30-day mortality. RESULTS The mortality rate in patients with in-hospital bleeding was significantly higher than that in outpatients (8.9% vs 3.8%; odds ratio [OR] 2.44; 95% confidence interval [CI], 1.57-3.79; P < .0001). Hemodynamic instability on presentation (OR 7.31; 95% CI, 2.71-19.65) and the presence of severe comorbidity (OR 6.72; 95% CI, 1.87-24.0) were the strongest predictors of death for in-hospital bleeders. Other independent predictors of mortality were a history of peptic ulcer disease and failed endoscopic treatment. Rebleeding was a strong predictor of death only for outpatients (OR 5.22; 95% CI, 2.45-11.10). Risk factors had a different prognostic impact on the 2 populations, resulting in a significantly different prognostic accuracy of the model (area under the receiver-operating characteristic curve = 0.83; 95% CI, 0.77-0-93 vs 0.74; 95% CI, 0.68-0.80; P < .02). LIMITATIONS Study design not experimental, no data on ward specialty, potential referral bias. CONCLUSIONS In-hospital bleeders have a significantly higher risk of death because they are sicker and more often hemodynamically unstable than outpatients. Predictors of death have a different impact in the 2 populations.

Mortality from nonulcer bleeding is similar to that of ulcer bleeding in high-risk patients with nonvariceal hemorrhage: A prospective database study in Italy

BACKGROUND Nonulcer causes of bleeding are often regarded as minor, ie, associated with a lower risk of mortality. OBJECTIVE To assess the risk of death from nonulcer causes of upper GI bleeding (UGIB). DESIGN Secondary analysis of prospectively collected data from 3 national databases. SETTINGS Community and teaching hospitals. PATIENTS Consecutive patients admitted for acute nonvariceal UGIB. INTERVENTIONS Early endoscopy, medical and endoscopic treatment as appropriate. MAIN OUTCOME MEASUREMENTS Thirty-day mortality, recurrent bleeding, and need for surgery. RESULTS A total of 3207 patients (65.8% male), mean (standard deviation) age 68.3 (16.4) years, were analyzed. Overall mortality was 4.45% (143 patients). According to the source of bleeding, mortality was 9.8% for neoplasia, 4.8% for Mallory-Weiss tears, 4.8% for vascular lesions, 4.4% for gastroduodenal erosions, 4.4% for duodenal ulcer, and 3.1% for gastric ulcer. Frequency of death was not different among benign endoscopic diagnoses (overall P = .567). Risk of death was significantly higher in patients with neoplasia compared with benign conditions (odds ratio 2.50; 95% CI, 1.32-4.46; P < .0001). Gastric or duodenal ulcer significantly increased the risk of death, but this was not related to the presence of high-risk stigmata (P = .368). The strongest predictor of mortality for all causes of nonvariceal UGIB was the overall physical status of the patient measured with the American Society of Anesthesiologists score (1-2 vs 3-4, P < .001). LIMITATIONS No data on the American Society of Anesthesiologists class score in the Prometeo study. CONCLUSIONS Nonulcer causes of nonvariceal UGIB have a risk of death, similar to bleeding peptic ulcers in the clinical context of a high-risk patient.

Primary extrahepatic bile duct carcinoids.

Biliary tact carcinoids are extremely rare: only ten cases have been reported up to now. The Authors describe a successfully treated carcinoid tumour ofthe proximal bile duct and review the literature about these rare malignancies. Despite extensive preoperative work-up, including ultrasound, CT scan and ERCP, a definite diagnosis is hardly possible prior to histologic examination of the operative or necropsy specimen. Due to the slow-growing nature and the non-aggressive behaviour of these malignancies, surgical resection followed by biliodigestive anastomosis should be the treatment of choice.