Silvano Loperfido

Major early complications from diagnostic and therapeutic ERCP: a prospective multicenter study

BACKGROUND There is a lack of multicenter prospective studies on complications of diagnostic and therapeutic endoscopic retrograde cholangiopancreatography (ERCP). METHODS We studied 2769 consecutive patients undergoing ERCP at nine centers in the Triveneto region of Italy over a 2-year period. Six centers performed ERCP on less than 200 patients per year (small centers). General and ERCP-specific major complications were predefined. Data were collected at the time of ERCP, before discharge, and in cases of readmission within 30 days. ERCP was defined as therapeutic when endoscopic sphincterotomy (n = 1583), precut (n = 419), or drainage (n = 701) had been carried out, singularly or in combination. RESULTS One hundred eleven major complications (4.0%) were recorded: moderate-severe pancreatitis 36 (1.3%), cholangitis 24 (0.87%), hemorrhage 21 (0.76%), duodenal perforation 16 (0.58%), others 14 (0.51%). Among 942 diagnostic ERCPs there were 13 major complications (1.38%) and 2 deaths (0.21%), whereas among 1827 therapeutic ERCPs there were 98 major complications (5.4%) and 9 deaths (0.49%). The difference in the incidence of complications between diagnostic and therapeutic ERCPs was statistically significant (p < 0.0001). Small center and precut were recognized as independent risk factors for overall major complications of therapeutic ERCP, whereas the following risk factors were identified in relation to specific complications: (1) pancreatitis: age less than 70 years, pancreatic duct opacification, and nondilated common bile duct; (2) cholangitis: small center, jaundice; (3) hemorrhage: small center; and (4) retroperitoneal duodenal perforation: precut, intramural injection of contrast medium, and Billroth II gastrectomy. CONCLUSIONS Major complications are mostly associated with therapeutic procedures and low case volume. Present data support a policy of centralization of ERCP in referral centers. A more selected and safer use of precut may be expected to further limit the adverse events of ERCP.

Incidence rates of post-ERCP complications: A systematic survey of prospective studies

OBJECTIVES:To provide health-care providers, patients, and physicians with an exhaustive assessment of prospective studies on rates of complications and fatalities associated with endoscopic retrograde cholangiopancreatography (ERCP).METHODS:We searched MEDLINE (1977–2006) for prospective surveys on adult patients undergoing ERCP. “Grey literature” was sought by looking at cited references to identify further relevant studies. Data on postprocedural pancreatitis, bleeding, infections, perforations, and miscellaneous events as well as their associated fatalities were extracted independently by two reviewers. Sensitivity analysis was performed to test for data consistency between multicenter versus single center studies, and old (1977–1996) versus recent (1997–2005) reports.RESULTS:In 21 selected surveys, involving 16,855 patients, ERCP-attributable complications totaled 1,154 (6.85%, CI 6.46–7.24%), with 55 fatalities (0.33%, CI 0.24–0.42%). Mild-to-moderate events occurred in 872 patients (5.17%, CI 4.83–5.51%), and severe events in 282 (1.67%, CI 1.47–1.87%). Pancreatitis occurred in 585 subjects (3.47%, CI 3.19–3.75%), infections in 242 (1.44%, CI 1.26–1.62%), bleeding in 226 (1.34%, CI 1.16–1.52%), and perforations in 101 (0.60%, CI 0.48–0.72%). Cardiovascular and/or analgesia-related complications amounted to 173 (1.33%, CI 1.13–1.53%), with 9 fatalities (0.07%, CI 0.02–0.12%). As compared with old reports, morbidity rates increased significantly in most recent studies: 6.27% versus 7.51% (Pc = 0.029).CONCLUSIONS:ERCP remains the endoscopic procedure that carries a high risk for morbidity and mortality. Complications continue to occur at a relatively consistent rate. The majority of events are of mild-to-moderate severity.

Changing trends in acute upper-GI bleeding: a population-based study.

BACKGROUND Advances in medical practice in recent decades have influenced the etiology and management of acute upper-GI bleeding (UGIB), but their impact on the incidence and mortality is unclear. OBJECTIVE To analyze the time trends of UGIB in 2 different management eras. DESIGN Prospective observational study. SETTING General university-affiliated hospital. PATIENTS AND INTERVENTIONS A total of 587 patients who presented with UGIB during the 1983-to-1985 period were compared with 539 patient in the 2002-to-2004 period. RESULTS The overall incidence of UGIB decreased from 112.5 to 89.8 per 100,000/y, which corresponds to a 35.5% decrease after adjustment for age (95% CI, 24.2%-46.8%). The age standardized incidence of ulcer bleeding decreased by 41.6% (95% CI, 27.2%-56%); the decrease occurred only in people younger than 70 years of age. The rate of history of peptic ulcer disease decreased from 32.7% in the 1983-to-1985 period versus 19.5% in the 2002-to-2004 period (P < .001). The mean age increased from 61.0 to 68.7 years (P < .001), and the male:female ratio decreased from 2.7 to 1.8 (P = .002). The comorbidities increased from 69% to 75% (P = .01), the use of nonsteroidal anti-inflammatory drugs from 40.0% to 46.4% (P = .03), and the cases of bleeding occurring during hospitalization from 10.4% to 17.1% (P < .001). In the 1983-to-1985 cohort, the endoscopy was solely diagnostic, and antisecretory therapy consisted of H2-antagonists drugs. In the second period, 39.3% of patients underwent endoscopic therapy, whereas proton pump inhibitors were administered in 47%. Rebleeding rates decreased from 32.5% to 7.4% (P < .001) and surgery from 10.2% to 2.0% (P < .001). Overall mortality decreased from 17.1 to 8.2 per 100,000/y, which corresponded to a 60.8% decrease after adjustment for age (95% CI, 46.5%-75.1%). The age standardized mortality rate for ulcer bleeding decreased by 56.5% (95% CI, 41.9%-71.1%). LIMITATIONS A single-center study and a potential lack of generalizability. CONCLUSIONS From the 1983-to-1985 period to the 2002-to-2004 period, major changes occurred in the incidence of UGIB, features of patients, management, and outcomes. The incidence and mortality of UGIB overall and ulcer bleeding decreased significantly, and the decline of incidence occurred only in patients younger than 70 years old.

Prophylaxis of ERCP-related pancreatitis: A randomized, controlled trial of somatostatin and gabexate mesylate

BACKGROUND & AIMS It still is debated whether post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis can be prevented by administering either somatostatin or gabexate mesylate. The aim of the study is to assess the efficacy of a 6.5-hour infusion of somatostatin or gabexate mesylate in preventing ERCP-related complications. METHODS In a double-blind multicenter trial, 1127 patients undergoing ERCP were randomly assigned to intravenous administration of somatostatin (750 microg; n = 351), gabexate mesylate (500 mg; n = 381), or placebo (saline; n = 395). The drug infusion started 30 minutes before and continued for 6 hours after endoscopy. Patients were evaluated clinically, and serum amylase levels were determined at 4, 24, and 48 hours after endoscopy. RESULTS No significant differences in incidences of pancreatitis, hyperamylasemia, or abdominal pain were observed among the placebo (4.8%, 32.6%, and 5.3%, respectively), somatostatin (6.3%, 26.8%, and 5.1%, respectively), and gabexate mesylate groups (5.8%, 31.5%, and 6.3%, respectively). Univariate analysis of patient characteristics and endoscopic maneuvers showed that a Freeman score >1 (P < 0.0001), >/=3 pancreatic injections (P < 0.00001), and precut sphincterotomy (P = 0.01) were significantly associated with post-ERCP pancreatitis. At multiple logistic regression analysis, >/=3 pancreatic injections (odds ratio [OR], 1.95; 95% confidence interval [CI], 1.45-2.63) and a Freeman score >1 (OR, 1.47; 95% CI, 1.11-1.94) retained their predictive power. CONCLUSIONS Long-term (6.5-hr) administration of either somatostatin or gabexate mesylate is ineffective for the prevention of post-ERCP pancreatitis. Pancreatic injury seems to be related to difficulty in common bile duct access.

High- versus low-dose proton pump inhibitors after endoscopic hemostasis in patients with peptic ulcer bleeding: A multicentre, randomized study

BACKGROUND:The most effective schedule of proton pump inhibitor (PPI) administration following endoscopic hemostasis of bleeding ulcers remains uncertain.METHODS:Patients with actively bleeding ulcers and those with nonbleeding visible vessel or adherent clot were treated with epinephrine injection and/or thermal coagulation, and randomized to receive intravenous PPIs according to an intensive regimen (80 mg bolus followed by 8 mg/h as continuous infusion for 72 h) or a standard regimen (40 mg bolus daily followed by saline infusion for 72 h). After the infusion, all patients were given 20 mg PPI twice daily orally. The primary end point was the in-hospital rebleeding rate, as ascertained at the repeat endoscopy.RESULTS:Bleeding recurred in 28 of 238 patients (11.8%) receiving the intensive regimen, and in 19 of 236 (8.1%) patients receiving the standard regimen (P = 0.18). Most rebleeding episodes occurred during the initial 72-h infusion: 18 (7.6%) and 19 events (8.1%) in the intensive and standard groups, respectively (P = 0.32). Mean units of blood transfused were 1.7 ± 2.1 in the intensive and 1.5 ± 2.1 in the standard regimen group (P = 0.34). The duration of hospital stay was <5 days for 88 (37.0%) and 111 patients (47.0%) in the intensive and standard groups (P = 0.03). There were fewer surgical interventions in the standard versus intensive regimen (1 vs 3). Five patients in each treatment group died.CONCLUSIONS:Following endoscopic hemostasis of bleeding ulcers, standard-dose PPIs infusion was as effective as a high-dose regimen in reducing the risk of recurrent bleeding. (ClinicalTrials.gov number, NCT00374101).

Development and Validation of an Endoscopic Classification of Diverticular Disease of the Colon: The DICA Classification

Background: A validated endoscopic classification of diverticular disease (DD) of the colon is lacking at present. Our aim was to develop a simple endoscopic score of DD: the Diverticular Inflammation and Complication Assessment (DICA) score. Methods: The DICA score for DD resulted in the sum of the scores for the extension of diverticulosis, the number of diverticula per region, the presence and type of inflammation, and the presence and type of complications: DICA 1 (≤3), DICA 2 (4-7) and DICA 3 (>7). A comparison with abdominal pain and inflammatory marker expression was also performed. A total of 50 videos of DD patients were reassessed in order to investigate the predictive role of DICA on the outcome of the disease. Results: Overall agreement in using DICA was 0.847 (95% confidence interval, CI, 0.812-0.893): 0.878 (95% CI 0.832-0.895) for DICA 1, 0.765 (95% CI 0.735-0.786) for DICA 2 and 0.891 (95% CI 0.845-0.7923) for DICA 3. Intra-observer agreement (kappa) was 0.91 (95% CI 0.886-0.947). A significant correlation was found between the DICA score and C-reactive protein values (p = 0.0001), as well as between the median pain score and the DICA score (p = 0.0001). With respect to the 50 patients retrospectively reassessed, occurrence/recurrence of disease complications was recorded in 29 patients (58%): 10 (34.5%) were classified as DICA 1 and 19 (65.5%) as DICA 2 (p = 0.036). Conclusions: The DICA score is a simple, reproducible, validated and easy-to-use endoscopic scoring system for DD of the colon.

Bleeding peptic ulcer occurring in hospitalized patients: analysis of predictive and risk factors and comparison with out-of-hospital onset of hemorrhage.

We reviewed 84 consecutive cases of peptic ulcer hemorrhage, which occurred, in an area of 270,000 people, from 1986 to 1988, in patients already hospitalized for other diseases (in-bleeders). These subjects were compared with a prospective series of 386 patients who initially bled as out-patients and were then admitted (out-bleeders). Of 84 hemorrhages in hospitalized patients, 41 followed major surgery, while 43 were associated with other severe conditions. Bleeding site was duodenal in two thirds. Mean age was 67 ± 15 years versus 59 ± 15 among out-bleeders. Fifty percent of in-bleeders had recently received nonsteroidal antiinflammatory drugs (NSAIDs), and one third were on anticoagulants and 10% on corticosteroids; in 39 (46%) bleeding was shown to be persistent or recurrent, 5 (5.9%) underwent endoscopic and 18 (21%) surgical therapy; 29 died (34%). The corresponding figures among out-bleeders were: further bleeding 80 (20.7%), endoscopic therapy 12 (3.1%), surgery 25 (6.5%), deaths 17 (4.4%). As regards in-bleeders, only active bleeding and endoscopic stigmata emerged as statistically significant risk factors for further bleeding. The latter was shown to be significantly related to mortality. The most relevant finding was, however, that NSAIDs and anticoagulants, in association with stress and aging, are very frequently involved in peptic ulcer bleeding of hospitalized patients. The fatal outcome of one third, despite all available treatments, highlights the importance of prevention against drug- and stress-related mucosal damage in in-patients suffering from severe diseases.

Comparison of upper gastrointestinal bleeding in UK and in Treviso area (Italy): similarities and differences

We have read with great interest the papers of Hearnshaw and colleagues1 ,2 reporting a prospective nationwide survey on acute upper gastrointestinal bleeding carried out in the UK in 2007. We would like to draw the attention to similarities and dissimilarities of this unique study compared with the results of a prospective population-based single-centre study we carried out in 2002–4 in the Treviso area (north-east Italy).3 Both surveys have taken a similar approach including data records on epidemiological and clinical features, variceal and non-variceal bleeding, emergency admissions and inhospital patients. In table 1 common recorded findings of this English study have …

Efficacy Versus effectiveness of octreotide in the prophylaxis of post-ERCP pancreatitis.

TO THE EDITOR: We read with interest the results of the randomized trial carried out by Li et al. on the prophylactic benefit of octreotide administration in reducing pancreatic damage after ERCP (1). In this study, the drug was able to reduce the incidence of postprocedural pancreatitis to one half that of the control group. Unfortunately, the authors did provide any explanation for the discrepancy between positive results of the present study and negative data of a previous meta-analysis (2) and recent trials on this topic (3,4). Furthermore, they used a per-protocol analysis of their data, instead of the more appropriate intention-to-treat analysis. Indeed, they mention that of the 479 patients randomized to octreotide, 65 patients were excluded without providing reasons for such an action. Although this also happened in controls (482 patients randomized and 64 evaluated), one wonders how this exclusion might have affected the final results.

Mo1385 Role of the Colon Cancer Screening Programme on Inflammatory Bowel Disease New Diagnosis. One Year Experience in an Italian North-East Area

Entero-Urinary Fistulas in Crohns Disease: Prevalence and Clinical Manifestations Carlos Taxonera, Ignacio Fernandez-Blanco, Manuel Barreiro-de Acosta, Guillermo Bastida, Antonio Lopez-SanRoman, Olga Merino, Valle Garcia-Sanchez, Javier P. Gisbert, Ignacio Marin-Jimenez, Pilar Lopez-Serrano, Eva Iglesias Flores, Javier Martinez-Gonzalez, Maria Chaparro, Fernando Bermejo, Cristina Saro, Leticia Perez-Carazo, Rocio Plaza, David Olivares, Maria M. Canas, Juan L. Mendoza