Livio Cipolletta

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.

Meta‐analysis: capsule enteroscopy vs. conventional modalities in diagnosis of small bowel diseases

Background : Prospective trials support the role of capsule enteroscopy as an improvement in diagnosing mucosal lesions in the small bowel.

Diagnosis and management of nonvariceal upper gastrointestinal hemorrhage: European Society of Gastrointestinal Endoscopy (ESGE) Guideline

This Guideline is an official statement of the European Society of Gastrointestinal Endoscopy (ESGE). It addresses the diagnosis and management of nonvariceal upper gastrointestinal hemorrhage (NVUGIH). Main Recommendations MR1. ESGE recommends immediate assessment of hemodynamic status in patients who present with acute upper gastrointestinal hemorrhage (UGIH), with prompt intravascular volume replacement initially using crystalloid fluids if hemodynamic instability exists (strong recommendation, moderate quality evidence). MR2. ESGE recommends a restrictive red blood cell transfusion strategy that aims for a target hemoglobin between 7 g/dL and 9 g/dL. A higher target hemoglobin should be considered in patients with significant co-morbidity (e. g., ischemic cardiovascular disease) (strong recommendation, moderate quality evidence). MR3. ESGE recommends the use of the Glasgow-Blatchford Score (GBS) for pre-endoscopy risk stratification. Outpatients determined to be at very low risk, based upon a GBS score of 0 - 1, do not require early endoscopy nor hospital admission. Discharged patients should be informed of the risk of recurrent bleeding and be advised to maintain contact with the discharging hospital (strong recommendation, moderate quality evidence). MR4. ESGE recommends initiating high dose intravenous proton pump inhibitors (PPI), intravenous bolus followed by continuous infusion (80 mg then 8 mg/hour), in patients presenting with acute UGIH awaiting upper endoscopy. However, PPI infusion should not delay the performance of early endoscopy (strong recommendation, high quality evidence). MR5. ESGE does not recommend the routine use of nasogastric or orogastric aspiration/lavage in patients presenting with acute UGIH (strong recommendation, moderate quality evidence). MR6. ESGE recommends intravenous erythromycin (single dose, 250 mg given 30 - 120 minutes prior to upper gastrointestinal [GI] endoscopy) in patients with clinically severe or ongoing active UGIH. In selected patients, pre-endoscopic infusion of erythromycin significantly improves endoscopic visualization, reduces the need for second-look endoscopy, decreases the number of units of blood transfused, and reduces duration of hospital stay (strong recommendation, high quality evidence). MR7. Following hemodynamic resuscitation, ESGE recommends early (≤ 24 hours) upper GI endoscopy. Very early (< 12 hours) upper GI endoscopy may be considered in patients with high risk clinical features, namely: hemodynamic instability (tachycardia, hypotension) that persists despite ongoing attempts at volume resuscitation; in-hospital bloody emesis/nasogastric aspirate; or contraindication to the interruption of anticoagulation (strong recommendation, moderate quality evidence). MR8. ESGE recommends that peptic ulcers with spurting or oozing bleeding (Forrest classification Ia and Ib, respectively) or with a nonbleeding visible vessel (Forrest classification IIa) receive endoscopic hemostasis because these lesions are at high risk for persistent bleeding or rebleeding (strong recommendation, high quality evidence). MR9. ESGE recommends that peptic ulcers with an adherent clot (Forrest classification IIb) be considered for endoscopic clot removal. Once the clot is removed, any identified underlying active bleeding (Forrest classification Ia or Ib) or nonbleeding visible vessel (Forrest classification IIa) should receive endoscopic hemostasis (weak recommendation, moderate quality evidence). MR10. In patients with peptic ulcers having a flat pigmented spot (Forrest classification IIc) or clean base (Forrest classification III), ESGE does not recommend endoscopic hemostasis as these stigmata present a low risk of recurrent bleeding. In selected clinical settings, these patients may be discharged to home on standard PPI therapy, e. g., oral PPI once-daily (strong recommendation, moderate quality evidence). MR11. ESGE recommends that epinephrine injection therapy not be used as endoscopic monotherapy. If used, it should be combined with a second endoscopic hemostasis modality (strong recommendation, high quality evidence). MR12. ESGE recommends PPI therapy for patients who receive endoscopic hemostasis and for patients with adherent clot not receiving endoscopic hemostasis. PPI therapy should be high dose and administered as an intravenous bolus followed by continuous infusion (80 mg then 8 mg/hour) for 72 hours post endoscopy (strong recommendation, high quality evidence). MR13. ESGE does not recommend routine second-look endoscopy as part of the management of nonvariceal upper gastrointestinal hemorrhage (NVUGIH). However, in patients with clinical evidence of rebleeding following successful initial endoscopic hemostasis, ESGE recommends repeat upper endoscopy with hemostasis if indicated. In the case of failure of this second attempt at hemostasis, transcatheter angiographic embolization (TAE) or surgery should be considered (strong recommendation, high quality evidence). MR14. In patients with NVUGIH secondary to peptic ulcer, ESGE recommends investigating for the presence of Helicobacter pylori in the acute setting with initiation of appropriate antibiotic therapy when H. pylori is detected. Re-testing for H. pylori should be performed in those patients with a negative test in the acute setting. Documentation of successful H. pylori eradication is recommended (strong recommendation, high quality evidence). MR15. In patients receiving low dose aspirin for secondary cardiovascular prophylaxis who develop peptic ulcer bleeding, ESGE recommends aspirin be resumed immediately following index endoscopy if the risk of rebleeding is low (e. g., FIIc, FIII). In patients with high risk peptic ulcer (FIa, FIb, FIIa, FIIb), early reintroduction of aspirin by day 3 after index endoscopy is recommended, provided that adequate hemostasis has been established (strong recommendation, moderate quality evidence).

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.

Prospective comparison of argon plasma coagulator and heater probe in the endoscopic treatment of major peptic ulcer bleeding

BACKGROUND Argon plasma coagulator was prospectively compared with heater probe in patients with bleeding peptic ulcers. METHODS Forty-one patients with major stigmata of ulcer hemorrhage were randomly assigned to receive either heater probe (n = 20) or argon plasma coagulation (n = 21) treatment; 40% had active bleeding and 60% had a nonbleeding visible vessel in the ulcer crater. The two groups were similar with respect to all background variables. Episodes of recurrent bleeding were retreated with the same modality as used previously. Patients in whom treatment or retreatment failed underwent emergency surgery. RESULTS Initial hemostasis (95% vs. 95.2%), recurrent bleeding (21% vs. 15%), 30-day mortality (5% vs. 4.7%), and emergency surgery (15% vs. 9.5%) were comparable in the heater probe and argon plasma coagulation groups, respectively. Argon plasma coagulation provided faster hemostasis (mean 60 +/- 19 vs. 115 +/- 28 seconds, p < 0.05). CONCLUSIONS Argon plasma coagulation is safe and effective. Larger studies in patients with bleeding peptic ulcers are needed to confirm these promising results.

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.

Argon plasma coagulation prevents variceal recurrence after band ligation of esophageal varices: Preliminary results of a prospective randomized trial

BACKGROUND Endoscopic variceal ligation is an established procedure for eradication of esophageal varices. However, varices frequently recur after endoscopic variceal ligation. Argon plasma coagulation has been used as supplemental treatment for eradication of varices and for prevention of variceal recurrence in small uncontrolled series. The aim of this study was to determine whether argon plasma coagulation is effective in reducing variceal recurrence after endoscopic variceal ligation. METHODS Thirty patients with cirrhosis, a history of acute esophageal variceal bleeding, and eradication of varices by endoscopic variceal ligation were randomized to argon plasma coagulation (16 patients) or observation (14 patients). The 2 groups were similar with respect to all background variables including age, Child-Pugh score, presence of gastric varices, and degree of portal hypertensive gastropathy. In the argon plasma coagulation group, the entire esophageal mucosa 4 to 5 cm proximal to the esophagogastric junction was thermocoagulated circumferentially with argon plasma coagulation in 1 to 3 sessions performed at weekly intervals. Endoscopy was performed every 3 months to check for recurrence of varices in both groups. RESULTS During the course of the study, no serious complication was noted. After argon plasma coagulation, transient fever occurred in 13 patients and 8 complained of dysphagia or retrosternal pain/discomfort. Mean follow-up for all patients was 16 months (range 9-28 months). No recurrence of varices or variceal hemorrhage was observed in the argon plasma coagulation group, whereas varices recurred in 42.8% (6/14) of the patients in the control group (p < 0.04) and bleeding recurred in 7.2% (1/14). CONCLUSIONS Argon plasma coagulation of the distal esophageal mucosa after eradication of esophageal varices by endoscopic variceal ligation is safe and effective for reducing the rate of variceal recurrence.

Prevalence of nonpolypoid colorectal neoplasia: an Italian multicenter observational study.

BACKGROUND AND STUDY AIM The aim of this study was to assess the prevalence of nonpolypoid lesions (NPLs) in Italy and their risk of containing neoplasia or advanced histology. PATIENTS AND METHODS This was a multicenter cross-sectional observational study on consecutive patients undergoing total colonoscopy over a 3-month period in 80 Italian centers. RESULTS In all, 27,400 total colonoscopies were analyzed. Cancer was diagnosed in 801 patients (2.9 %). A total of 6553 precancerous lesions were detected in 5609 patients. Of these, 4154 patients (74.1 %) had polypoid lesions and 1455 patients (25.9 %) had NPLs. Therefore, the prevalence of NPLs was 5.3 % (95 %CI 5.0 - 5.6). NPLs larger than 10 mm were detected in 254 patients (17.5 %). NPLs were more predominant in the proximal colon (OR 2.92, 95 %CI 2.56 - 3.43; P < 0.0001 vs. polypoid lesions). Neoplastic tissue was diagnosed in 79.0 % and advanced histology (high-grade intraepithelial neoplasia or more) in 20.9 % of resected lesions. The risk of advanced histology was similar for polypoid and nonpolypoid lesions when adjusted for size. Depressed lesions had the highest risk of advanced histology (OR 10.56, 95 %CI 6.02 - 18.55; P < 0.0000 vs. flat-elevated). Age was an independent predictor of both neoplasia and advanced histology ( P = 0.0001). CONCLUSIONS NPLs are relatively common in the Italian population, with a prevalence similar to that in other Western series. NPLs are not more aggressive than polypoid lesions, except for those with depressed morphology.