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ERCP practice today: implications for training

Prospective studies have identified a number of patient- and procedure-related independent risk factors for post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis, with different conclusions, so various questions are still open. The endoscopist's expertise, case volume, and case mix can all significantly influence the outcome of ERCP procedures, but have been investigated little to date. We identified patient- and procedure-related risk factors for post-ERCP pancreatitis and the impact of the endoscopist's experience and the center's case volume, using univariate and multivariate analysis, in a multicenter, prospective study involving low- and high-volume centers, over a 6-month period. A total of 3,635 ERCP procedures were included; 2,838 (78%) ERCPs were performed in the 11 high-volume centers (median 257 each) and 797 in the 10 low-volume centers (median 45 each). Overall, 3,331 ERCPs were carried out by expert operators and 304 by less-skilled operators. There were significantly more grade 3 difficulty procedures in high-volume centers than in low-volume ones (P<0.0001). Post-ERCP pancreatitis occurred in 137 patients (3.8%); the rates did not differ between high- and low-volume centers (3.9% vs. 3.1%) and expert and non-expert operators (3.8% vs. 5.5%). However, in high-volume centers, there were 25% more patients with patient- and procedure-related risk factors, and the pancreatitis rate was one-third higher among non-expert operators. Univariate analysis found a significant association with pancreatitis for history of acute pancreatitis, either non-ERCP- or ERCP-related and recurrent, young age, absence of bile duct stones, and biliary pain among patient-related risk factors, and >10 attempts to cannulate the Vater's papilla, pancreatic duct cannulation, contrast injection of the pancreatic ductal system, pre-cut technique, and pancreatic sphincterotomy, among procedure-related risk factors. Multivariate analysis also showed that a history of post-ERCP pancreatitis, biliary pain, >10 attempts to cannulate the Vater's papilla, main pancreatic duct cannulation, and pre-cut technique were significantly associated with the complication. A history of pancreatitis among patient-related factors, and multiple attempts at cannulation among procedure-related factors, were associated with the highest rates of post-ERCP pancreatitis. Pre-cut sphincterotomy, although identified as another significant risk factor, appeared safer when done early (fewer than 10 attempts at cannulating), compared with repeated multiple cannulation. The risk of post-ERCP pancreatitis was not associated with the case volume of either the single endoscopist or the center; however, high-volume centers treated a larger proportion of patients at high risk of pancreatitis and did a significantly greater number of difficult procedures.

The aim was to compare patients' and endoscopists' satisfaction in terms of efficacy and safety of remifentanil patient-controlled analgesia (PCA) during colonoscopy with that of a combination of midazolam and meperidine. Sixty patients undergoing colonoscopy were randomly assigned to two groups. All of the patients received midazolam 0.03 mg/kg intravenously for premedication. In the remifentanil group, a bolus dose of remifentanil was given, and a patient-controlled sedation analgesia (PCSA) pump was set to inject further bolus doses with no \"lockout\" time. Patients in the meperidine group received a bolus of meperidine and sham PCSA. Non-invasive arterial blood pressure, electrocardiography, and pulse oximetry were monitored throughout the study. The Observer's Assessment of Alertness and Sedation Scale (OAA/S) was performed at baseline, every 5 min during, and after colonoscopy. Assessment of pain and satisfaction with sedoanalgesia was scheduled after colonoscopy and 24-72 h later by a 100 mm visual analog scale (VAS). The technical difficulty of the examination and the gastroenterologist's satisfaction were assessed similarly. The degree of pain, the level of satisfaction with sedoanalgesia by patients and gastroenterologists, and the degree of difficulty experienced by the endoscopist were not different in the two groups. The time to reach an Aldrete score > or = 9 was significantly shorter in the remifentanil group (P < 0.0001); discharge times did not differ between the groups (P = 0.36). There was no difference between the groups regarding the duration of colonoscopy (P = 0.82) and the stability of vital signs. At the end of the procedure, OAA/S was significantly higher in the remifentanil group (P = 0.03). Remifentanil PCA is safe and effective to induce sedoanalgesia during colonoscopy. Further studies should address the optimization of dosing and lock out setting.

Introduction Transoral incisionless fundoplication (TIF) with the EsophyX ™ device is reported to be effective for creating a continent gastroesophageal valve and for good functional results, as measured by pH impedance in patients with gastroesophageal reflux disease (GERD). The aim of this study is to assess the long-term effect of TIF in patients with symptomatic GERD. Patients and methods TIF 2.0 fundoplication was done in 42 consecutive patients. All were studied with GERD-HRQL and GERD-QUAL questionnaires, upper gastrointestinal (GI) endoscopy, esophageal manometry, and 24 h pH impedance before and at 6, 12, and 24 months after TIF. Results In all, 35 patients completed 6-month follow-up; 21 (60.0%) completely stopped proton pump inhibitor (PPI) therapy, 6 (17.1%) more than halved it, and 8 (22.9%) continued with the same dose as before the procedure. There were 26 patients with complete 24-month follow-up; 11 (42.3%) completely stopped PPI therapy, 7 (26.9%) more than halved it, and 8 (30.8%) were taking the same dose as before the procedure. Hiatal hernia and ineffective esophageal motility seemed to raise the risk of recurrence of symptoms ( p  = 0.02 and p  < 0.001, respectively). The number of fasteners deployed during TIF was the only factor predictive of successful outcome ( p  = 0.018). Conclusions TIF using the EsophyX device allowed withdrawal or reduction of PPI in about 77% of patients at 6-month follow-up and about 69% at 24 months. Larger number of fasteners deployed during TIF was predictive of positive outcome; pre-TIF ineffective esophageal motility and hiatal hernia raised the risk of recurrence of GERD symptoms, but were not significant from a prospective point of view.

Clinical guidelines recommend radiofrequency ablation (RFA) for eradication of Barrett esophagus in patients with low-grade dysplasia (LGD) and high-grade dysplasia (HGD), but evidence on whether RFA provides good value for money is still sparse. This study evaluates the cost-effectiveness of RFA in Italy. A Markov model was used to estimate lifelong costs and consequences of disease progression with different treatments. RFA was compared with esophagectomy in the HGD group or endoscopic surveillance in the LGD group. Clinical and quality-of-life parameters were derived from a review of the literature and expert opinions, whereas Italian national tariffs were used as a proxy for costs. RFA dominated esophagectomy in patients with HGD with a probability of 83%. For patients with LGD, RFA was more effective and more costly than active surveillance (incremental cost-effectiveness ratio, €6276 per quality-adjusted life-year). At a cost-effectiveness threshold of €15,272, the probability of RFA being the optimal strategy in this population was close to 100%. Model results were sensitive to the cost of the interventions and utility weights used in the different disease states. RFA is likely to be the optimal choice for patients with LGD and HGD in Italy. Italy is discussing the implementation of a national program for the health technology assessment of medical devices, requiring more studies to prove value for money of emerging technologies.

Background. The large number of lesions detected via high-definition (HD) imaging during colonoscopy calls for the reliable real-time histological characterization of polyps, especially diminutive and small ones, to permit tailored management based on the neoplastic risk, such as a “resect-and-discard” or a “diagnose-and-leave” strategy for low-risk adenomas and hyperplastic polyps (HPs). The Kudo classification of glandular pit pattern is currently used for predicting polyp histology. Aim. The aim in this study was to assess whether Kudo’s glandular pit pattern, assessed via HD digital chromoendoscopy (i-Scan) without magnification and optical enhancement, reliably predicts polyp histology and differentiates neoplastic lesions (NLs) from non-neoplastic lesions (non-NLs) during routine colonoscopy. Methods. Consecutive colorectal lesions recorded in a database over 12 months, with Kudo’s glandular pit pattern classification, were retrospectively compared with histology. The diagnostic accuracy and negative predictive value (NPV) for adenomatous histology of Kudo’s pit patterns were assessed separately for diminutive (≤5 mm) and small (6–9 mm) polyps, accordingly to the American Society for Gastrointestinal Endoscopy (ASGE) Preservation and Incorporation of Valuable Endoscopic Innovations (PIVI), and in large (≥10 mm) lesions. Results. A total of 2230 lesions were recorded: 898 diminutive, 704 small, and 628 large. Kudo’s type II pit pattern was prevalent in diminutive polyps and recognized mostly in HPs (83.27%); it was also found in 38.8% of adenomas. In the right colon, Kudo’s type II pit pattern was prevalent in adenomas (70.04% vs. 20.74% in HPs); among the serrated lesions, it was evenly distributed between HPs and adenomas. Kudo’s type IIIL/IIIs/IV pit pattern was prevalent in NLs (61% vs. 8.37% of non-NLs) in diminutive polyps, evenly distributed between non-NLs and NLs in small polyps, and found only in NLs in large polyps. Kudo’s type Vi/Vn pit pattern correctly identified all but one adenocarcinoma. The NPV for adenomatous histology did not reach the recommended 90% PIVI threshold for differentiation between NLs and non-NLs in diminutive polyps showing Kudo’s type II pit pattern and in small polyps showing type IIIL/IIIs/IV pit pattern. Conclusions. Kudo’s pit pattern classification carried out with digital chromoendoscopy (i-Scan) during routine colonoscopy does not allow the reliable differentiation between non-NLs and NLs in diminutive and small polyps, so a “diagnose-and-leave” strategy for diminutive polyps may leave undetected adenomas, while a “resect-and-discard” strategy could miss lesions requiring closer follow-up.

The possible role of Saccharomyces boulardii, a nonpathogenic yeast with beneficial effects on the human intestine, in the maintenance treatment of Crohn's disease has been evaluated. Thirty-two patients with Crohn's disease in clinical remission (CDAI < 150) were randomly treated for six months with either mesalamine 1 g three times a day or mesalamine 1 g two times a day plus a preparation of Saccharomyces boulardii 1 g daily. Clinical relapses as assessed by CDAI values were observed in 37.5% of patients receiving mesalamine alone and in 6.25% of patients in the group treated with mesalamine plus the probiotic agent. Our results suggest that Saccharomyces boulardii may represent a useful tool in the maintenance treatment of Crohn's disease. However, in view of the product's cost, further controlled studies are needed to confirm these preliminary data.

Alterations in mucin (MUC) glycosylation and expression have been described in cancer. Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) can provide material for molecular biology analysis. This study assessed the feasibility of evaluating MUC expression from material obtained by EUS-FNA and studied the profile of MUC expression in benign and malignant pancreatic lesions. A total of 90 patients with solid or cystic pancreatic lesions underwent FNA. The aspirated material was used for cytological analysis and RNA extraction to assess the expression pattern of MUCs by reverse transcription-PCR with primers specific for the MUC1, MUC2, MUC3, MUC4, MUC5A, MUC5B, MUC6, and MUC7 genes. RNA extraction was successful in 81% of the biopsies. The prevalences of MUC1, MUC2, MUC4, and MUC7 in ductal adenocarcinoma were 57.7, 51.4, 18.9, and 73.0%, respectively. Fifty percent of benign lesions and neuroendocrine tumors (NETs), and 63% of intraductal papillary mucinous neoplasms (IPMNs) were positive for MUC1. Twenty-five percent of benign lesions, 86% of NETs, and 47% of IPMNs were positive for MUC2. Of NETs, 50% were positive for MUC1, and 14% were positive for MUC7. None of the benign lesions or NETs expressed MUC4. MUC7 expression was highly significant for adenocarcinoma (P=0.007) and borderline for IPMN (P=0.05). MUC7 was expressed in 37.5% of chronic pancreatitis cases. RNA can be extracted from samples obtained under EUS-FNA. MUC7 could serve as a potential biological marker to identify malignant lesions, especially pancreatic adenocarcinoma.

Persistently high serum pancreatic enzymes in asymptomatic subjects are considered a benign idiopathic condition called \"non-pathological chronic pancreatic hyperenzymemia\" (CPH). However, recent studies with advanced imaging techniques have brought to light abnormal pancreatic findings in a significant proportion of these subjects. The objective of this study was to evaluate pancreatic ductal morphology by secretin-enhanced magnetic resonance cholangiopancreatography (MRCP-S) in subjects with CPH and compare MRCP imaging before and after secretin injection. In total, 25 consecutive patients with CPH were investigated by MRCP and MRCP-S and compared with 28 consecutive age-matched controls with recurrent upper abdominal pain and normal pancreatic enzymemia. MRCP-S showed abnormal pancreatic morphological findings in 13 of the 25 CPH cases (52%) and 1/28 controls (3.6%) (P<0.001). MRCP findings consistent with a diagnosis of chronic pancreatitis, according to the Cambridge classification, were detected in eight CPH cases (32%) after secretin injection but none of the controls. Secretin stimulation boosted the diagnostic yield of MRCP for the diagnosis of chronic pancreatitis fourfold. Pancreas divisum was identified in two CPH cases and one control. A 15-min persisting dilation of the main pancreatic duct was noted in three cases in each group. Compared with MRCP, MRCP-S showed significantly fewer CPH patients with normal findings (P<0.02). MRCP-S detected ductal findings consistent with chronic pancreatitis in one-third of CPH cases. Pancreas divisum and some dysfunction at the level of Vater's papilla were reported in 8 and 12% of the patients, respectively. MRCP-S is to be recommended, instead of MRCP, in the diagnostic work-up of CPH subjects.

Background: The role of microbiota in Lynch syndrome (LS) is still under debate. We compared oral and fecal microbiota of LS saliva and stool samples with normal healthy controls (NHC). Methods: Total DNA was purified from feces and saliva to amplify the V3–V4 region of the 16s rRNA gene. Sequences with a high-quality score and length >250 bp were used for taxonomic analysis with QIIME software. Results: Compared to NHC, LS fecal samples demonstrated a statistically significant increase of Bacteroidetes and Proteobacteria and a significant decrease of Firmicutes at the phylum level and of Ruminococcaceae at the family level. Moreover, LS oral samples exhibited a statistically significant increase of Veillonellaceae and Leptotrichiaceae and a statistically significant decrease of Pasteurellaceae. A beta-diversity index allowed differentiation of the two groups. Conclusions: A peculiar microbial signature is associated with LS, similar to that of sporadic colorectal cancer and Crohn’s disease. These data suggest a possible role of proinflammatory bacteria in tumor development in a condition of genetic predisposition, such as LS.