Endoscopic plastic stenting for bile duct stones: stent changing on demand or every 3 months. A prospective comparison study.

BACKGROUND AND STUDY AIMS: Endoscopic biliary sphincterotomy and stone removal is the standard of care for choledocholithiasis, with a success rate of > 90%. For stones ≤ 25 mm diameter, mechanical lithotripsy, extracorporeal shock wave lithotripsy, electrohydraulic lithotripsy, and laser lithotripsy can be used. In the case of failure, the next step is surgery. In elderly patients and in patients with an elevated surgical risk, stenting is the only treatment modality. In these cases the aim is to avoid the onset of acute obstructive cholangitis. The aim of the current study was to evaluate the best management of plastic stents in patients with biliary duct stones who were unfit for surgery and in whom previous endoscopic therapy had failed. METHODS: Patients who were high surgical risks and in whom stone clearance was not possible due to the number and sizes of stones were included. Between March 2008 and September 2010 all patients were treated with endoscopic plastic biliary stenting at four tertiary care referral centers in Italy. Patients were randomly assigned to two groups: in Group A (n=39) plastic stents were changed every 3 months or sooner if symptoms appeared; in Group B plastic stents were changed on demand at the onset of symptoms, and ultrasonography and blood samples were performed every 3 months to check for signs of cholestasis and inflammation. The primary outcome was the rate of cholangitis. The secondary outcome was the rate of stone clearance after a period of stenting. RESULTS: A total of 78 patients were included in the study (43 M/35F; mean age 76 years). Acute cholangitis occurred in 3 patients from Group A and in 14 patients from Group B (P=0.03). Mortality related to cholangitis occurred in one patient from Group A and three patients from Group B (P=n.s.). The mean follow-up was 13.5 months (range 2-23). Stone clearance after long term stenting occurred in 24 patients from Group A (61.5 %) and in 21 patients from group B (53.8%) (P=n.s.). CONCLUSIONS: In patients with bile duct stones who were treated with biliary plastic stents, the best stent management to avoid cholangitis was stent changing at defined intervals (every 3 months in the current study). The data confirmed that plastic biliary stenting may decrease stone size with a high percentage of subsequent total stone clearance.

Prognostic value of perinuclear antineutrophil cytoplasmic antibodies in subjects with primary sclerosing cholangitis.

BACKGROUND: The aim of this study was to evaluate the prognostic value of perinuclear antineutrophil cytoplasmic antibodies (p-ANCA) in subjects with primary sclerosing cholangitis (PSC) and in particular whether it is associated with inflammatory bowel disease (IBD). METHODS: In the last 9 years, 64 patients were admitted to our Hospital with PSC: 34 males, mean age 53 years, range 17-90. All the patients had a cholestatic pattern of elevated serum enzymes. The diagnosis was made in most cases with magnetic resonance and in small percentages with endoscopic retrograde cholangiopancreatography (ERCP) or liver biopsy. In 33 patients with PSC, colonoscopy and p-ANCA assays were possible. RESULTS: Thirteen patients showed p-ANCA positivity: 8 had ulcerative colitis (UC), with associated colon cancer (CC) in 3 cases, 3 had Crohn's disease (CD), 2 had no inflammatory bowel disease (IBD). Twenty patients were p-ANCA negative: only 1 with indeterminate IBD, while 19 had no IBD. CONCLUSIONS: IBD, or especially UC, is present in85% of patients with CSP and p-ANCA positivity, whereas 95% of patients with PSC who test negative for p-ANCA do not have IBD.

The GENIUS Grid Portal and robot certificates: a new tool for e-Science.

BACKGROUND: Grid technology is the computing model which allows users to share a wide pletora of distributed computational resources regardless of their geographical location. Up to now, the high security policy requested in order to access distributed computing resources has been a rather big limiting factor when trying to broaden the usage of Grids into a wide community of users. Grid security is indeed based on the Public Key Infrastructure (PKI) of X.509 certificates and the procedure to get and manage those certificates is unfortunately not straightforward. A first step to make Grids more appealing for new users has recently been achieved with the adoption of robot certificates. METHODS: Robot certificates have recently been introduced to perform automated tasks on Grids on behalf of users. They are extremely useful for instance to automate grid service monitoring, data processing production, distributed data collection systems. Basically these certificates can be used to identify a person responsible for an unattended service or process acting as client and/or server. Robot certificates can be installed on a smart card and used behind a portal by everyone interested in running the related applications in a Grid environment using a user-friendly graphic interface. In this work, the GENIUS Grid Portal, powered by EnginFrame, has been extended in order to support the new authentication based on the adoption of these robot certificates. RESULTS: The work carried out and reported in this manuscript is particularly relevant for all users who are not familiar with personal digital certificates and the technical aspects of the Grid Security Infrastructure (GSI). The valuable benefits introduced by robot certificates in e-Science can so be extended to users belonging to several scientific domains, providing an asset in raising Grid awareness to a wide number of potential users. CONCLUSION: The adoption of Grid portals extended with robot certificates, can really contribute to creating transparent access to computational resources of Grid Infrastructures, enhancing the spread of this new paradigm in researchers' working life to address new global scientific challenges. The evaluated solution can of course be extended to other portals, applications and scientific communities.

An analysis of the factors associated with the development of complications in patients undergoing precut sphincterotomy: a prospective, controlled, randomized, multicenter study.

OBJECTIVES: Precut is performed when biliary access at endoscopic retrograde cholangiopancreatography (ERCP) fails. Precut may have adjunctive risks, but some authors have suggested that the attempts to cannulate the papilla that precede precutting cause complications. We evaluated the role of the timing of precut in determining the development of complications and with respect to the other factors involved. METHODS: During ERCP, after 10 min of attempts to cannulate, patients were randomized to an early-precut group (n=77) undergoing precut immediately or a late-access group (n=74) in which cannulation was attempted for 10 further minutes before the endoscopist was free to perform precut or to persist in cannulation. Occurrence of complications and the associated risk factors were recorded. RESULTS: The two groups were similar for general characteristics. The number of attempts to cannulate, the number of pancreas injections, and the incidence of acinarization were higher in the late-access group. The cannulation rate was 94%. The incidence of overall complications was similar, but the pancreatitis rate was higher in the late-access group (14.9 vs. 2.6%, P=0.008). Amylase levels increased by 398.9+/-879.4 in the early-precut group and 833.6+/-1478.4 in the late-access group (P=0.029). Nondilated bile duct and pancreatic injection were related to the development of pancreatitis, whereas the performance of precut was related to other complications. CONCLUSIONS: Early precut is associated with lower pancreatitis rate, suggesting that pancreatitis develops as a consequence of the attempts to cannulate the papilla and pancreatic injection, and not precutting.

Administration Timing Is the Best Clinical Outcome Predictor for Adalimumab Administration in Crohn's Disease.

Biological intervention for Crohn's Disease (CDs) patients, mainly using anti-TNF antibodies, is often an efficient therapeutic solution. Nonetheless, data defining the administration timing to maximize the chances of clinical remission are lacking. The objective of this "real-life" retrospective study was to evaluate if early Adalimumab (ADA) administration (<12 months) was an efficient strategy to improve patients' clinical outcome. This single center study included 157 CD patients, of which 80 received the first ADA administration within the first 12 months from the diagnosis. After 1 year of therapy, clinical remission was observed in 50.32% of patients, mucosal healing in 37.58%. Clinical remission was observed in 66.25% of the early ADA administration patients vs. 33.77% of the late (>12 months) (p < 0.001); mucosal healing was observed in 53.75% of the early vs. 20.78% of the late (p < 0.001). Dose escalation was required for 30.00% of the early vs. 66.23% of the late (<0.01). In the early ADA administration group, 7.50% patients were considered non-responders at the end of the follow-up vs. 22.08% patients in the late administration group. These findings highlighted that early ADA administration (within 1 year of diagnosis) improves the clinical response and mucosal healing, and reduces the loss of response rate and need for dose escalation.

Quality of bowel cleansing in hospitalized patients undergoing colonoscopy: A multicentre prospective regional study.

BACKGROUND: Quality of bowel cleansing in hospitalized patients undergoing colonoscopy is often unsatisfactory. No study has investigated the inpatient or outpatient setting as cause of inadequate cleansing. AIMS: To assess degree of bowel cleansing in inpatients and outpatients and to identify possible predictors of poor bowel preparation in the two populations. METHODS: Prospective multicentre study on consecutive colonoscopies in 25 regional endoscopy units. Univariate and multivariate analysis with odds ratio estimation were performed. RESULTS: Data from 3276 colonoscopies were analyzed (2178 outpatients, 1098 inpatients). Incomplete colonoscopy due to inadequate cleansing was recorded in 369 patients (11.2%). There was no significant difference in bowel cleansing rates between in- and outpatients in both colonic segments. In the overall population, independent predictors of inadequate cleansing both at the level of right and left colon were: male gender (odds ratio, 1.20 [1.02-1.43] and 1.27 [1.05-1.53]), diabetes mellitus (odds ratio, 2.35 [1.68-3.29] and 2.12 [1.47-3.05]), chronic constipation (odds ratio, 1.60 [1.30-1.97] and 1.55 [1.23-1.94]), incomplete purge intake (odds ratio, 2.36 [1.90-2.94] and 2.11 [1.68-2.65]) and a runway time >12h (odds ratio, 3.36 [2.40-4.72] and 2.53 [1.74-3.67]). CONCLUSIONS: We found no difference in the rate of inadequate bowel preparation between hospitalized patients and outpatients.

Comparison of treatment outcomes between biliary plastic stent placements with and without endoscopic sphincterotomy for inoperable malignant common bile duct obstruction.

AIM: Considerable controversy surrounds the adoption of endoscopic sphincterotomy (ES) to facilitate the placement of 10F plastic stents (PS) and to reduce the risk of pancreatitis The aim of the study was to assess the possible advantages of ES before PS placement. METHODS: From 3/1996 to 6/2001, 172 consecutive patients, who underwent placement of a single 10F- polyethylene stent for inoperable malignant strictures of the common bile duct, were randomly assigned to 2 groups. In group A (96 patients), a ES was performed before PS placement In Group B, 96 patients had PS directly. Early complications (within 30 d) and late effects (from 30 d to stent replacement) were assessed. Patency interval was defined as the period between PS placement and obstruction or death. The success of stent replacement in the 2 groups was evaluated. RESULTS: Stent insertion was successful in 95.8%(92/96) of the pts in group A and in 93.7%(90/96) of the patients in group B (P>0.05). Early complications were more frequent in patients who underwent ES (6.5% vs 4.4%) but the data were not significant (P>0.05). In group A pancreatitis developed in two patients and bleeding in three; whereas pancreatitis occurred in 2 patients in group B. Complications were managed conservatively. No procedure related mortality occurred. All late complications were acute cholangitis due to stent occlusion. We performed a stent replacement in 87 patients that was successful in 84 cases without differences between groups. CONCLUSION: Sphincterotomy does not seem to be necessary for placement of 10F-PS in patients with malignant common bile duct obstruction.

Endoscopic dilation of benign colorectal anastomotic stricture after low anterior resection: A prospective comparison study of two balloon types.

BACKGROUND: Benign strictures arise in 5.8% to 20% of colorectal anastomoses. For such strictures, endoscopic dilation has proven to be a valid and safe treatment. A variety of endoscopic techniques have been proposed, but controlled prospective trials are lacking. This study compared dilation of this colorectal anastomotic stricture with an over-the-wire balloon designed for treatment of achalasia and with a through-the-scope balloon. METHODS: Thirty patients with symptoms caused by benign colorectal anastomotic stricture were randomly allocated to two treatment groups: 15 underwent dilation with a through-the-scope balloon and 15 had dilation with an over-the-wire balloon. Success was defined as an anastomotic lumen wide enough to allow passage of a standard 13-mm-diameter colonoscope, with resolution of symptoms. The success of dilation, the number of sessions required, the complications, and the duration of the dilation were recorded. Patients were followed for 24 months. RESULTS: Dilation was successful in all patients, with no procedure-related complication. The mean number of sessions required was 2.6 (0.98) in the through-the-scope group and 1.6 (0.77) in the over-the-wire group ( p = 0.009). The duration of response in days was greater in the over-the-wire group vs. the through-the-scope group, 560.8 (248.5) days vs. 294.2 (149.3) days, respectively, p = 0.016. CONCLUSIONS: Through-the-scope and over-the-wire dilation techniques are both effective and safe for treatment of benign colorectal anastomotic strictures. Using a greater diameter over-the-wire pneumatic balloon reduces the number of dilation sessions required and provides a longer-lasting response to dilation.

Relationship between hiatal hernia and inguinal hernia.

Several theories explain the development of hiatal hernia (HH). Since inguinal hernia (IH) is due to abdominal wall herniation, we hypothesized that if HH is caused by an excessive "push" from increased intraabdominal pressure, there would be a greater than chance association between HH and IH. The aim of this prospective case-control study was to determine the relationship between HH, identified at endoscopy, and IH, found on clinical examination. Outpatients, who were referred for elective upper GI endoscopy at the Endoscopic Unit, from January 1999 to December 1999, were evaluated. Data were collected regarding gender, age, BMI, presence or absence of HH, length of HH, and presence of IH on detailed abdominal examination of each subject. Five hundred fifty-nine outpatients were enrolled in this study. Of these, 128 (23%) had HH, whereas 431 (77%) patients did not. The average length of the HH was 2.7 +/- 0.9 cm (range, 1.5-6 cm). The overall risk of IH in patients with HH is 2.5-fold compared to those without HH (OR = 2.59). Obesity (BM, >25) was an additional risk factor for IH in patients with HH compared with normal weight (BMI, 21-25) (P < 0.05). Males with HH were more likely to have IH than females (OR = 2.86; 95% CI = 1.35-6.08). Inguinal and hiatal hernias occur together more often than expected by chance alone. Male gender and obesity increase the risk of association. These results suggest that a common etiology may exist for both IH and HH, at least in some patients, and support the hypothesis that "push" factors may contribute to the etiology of HH.