Prospective multicenter quality assessment of endotherapy of biliary stones: does center volume matter?

BACKGROUND AND STUDY AIMS: To study the effectiveness of endoscopic treatment for biliary stones in a large case list of patients treated in units with different experience and different workloads in a region of northern Italy. PATIENTS AND METHODS: We prospectively studied 700 patients undergoing endoscopic retrograde cholangiopancreatography or sphincterotomy, in 14 units (> or < 200 examinations/year), for their first treatment of biliary stones. The difficulty of the examinations, the results in terms of clearance of the stones, and the late outcomes (24 months) were recorded. A questionnaire (GHAA-9modified) was administered 24 hours and 30 days after the procedure to measure patient satisfaction. RESULTS: There were six units with a heavy workload and eight with a light schedule. There were 176 (25.1 %) difficult examinations (Schutz grades 3, 4, and 5). Stones were found in 580 (82.9 %) and were cleared in 504 of these patients (86.9 %). No differences were observed in the clearance of stones for the different groups of difficulty and high- and low-volume centers. Over the 24-month follow-up period, 96 patients (13.7 %) complained of recurrent symptoms and 44 (6.3 %) had proof of stones. In all, 603 questionnaires were evaluable and more than 80 % of patients expressed satisfaction. CONCLUSIONS: Our findings confirm the effectiveness of endoscopic treatment of biliary stones. However, the number of patients with symptoms (13.7) after 24 months, with or without persistence of stones, was not insignificant. It is feasible to record patient satisfaction, and in this series patients stated they were satisfied. Criticism mostly concerned pain control and explanations provided before the examination.

Octreotide 24-h prophylaxis in patients at high risk for post-ERCP pancreatitis: results of a multicenter, randomized, controlled trial.

BACKGROUND: Pharmacological prophylaxis of post-ERCP pancreatitis is costly and not useful in most non-selected patients, in whom the incidence of pancreatitis is 5% or less. However, it could be useful and probably cost-effective, in patients at high risk for this complication, where the post-procedure pancreatitis rate is 10% and more. AIM: To assess the efficacy of octreotide in reducing the incidence and severity of post-ERCP pancreatitis and procedure-related hospital stay, in subjects with known patient-related risk factors. METHODS: A total of 120 patients were randomly allocated to receive octreotide or not, in a multicentre, randomized, controlled trial. The drug was given subcutaneously, 200 microg t.d.s., starting 24 h before the ERCP procedure, in patients with either sphincter of Oddi dysfunction, or a history of relapsing pancreatitis or post-ERCP pancreatitis, or who were aged under 35 years, or who had a small common bile duct diameter (< 8 mm). RESULTS: A total of 114 patients (58 in the octreotide group and 56 in the control group) completed the trial. Post-procedure pancreatitis occurred in seven octreotide-treated patients (12.0%) and eight controls (14.3%). The two groups showed no significant differences in the incidence or severity of pancreatitis. Twenty-four hours after the procedure, severe hyperamylasemia (more than five times the upper normal limit) without pancreatic-like pain was recorded in three octreotide-treated patients (5.2%) and six controls (10.7%), the difference being not significant. CONCLUSION: Twenty-four-hour prophylaxis with octreotide proved ineffective in preventing post-ERCP pancreatitis and in avoiding 24-h severe hyperamylasemia in high-risk patients.

Complications of diagnostic and therapeutic ERCP: a prospective multicenter study.

OBJECTIVES: Diagnostic and therapeutic endoscopic retrograde cholangiopancreatography (ERCP/ES) can be associated with unforeseeable complications, especially when involving postprocedural pancreatitis. The aim of the study was to investigate risk factors for complications of ERCP/ES in a prospective multicentric study. METHODS: One hundred fifty variables were prospectively collected at time of ERCP/ES and before hospital discharge over 2 years, in consecutive patients undergoing the procedure in nine endoscopic units in the Lombardy region of Italy. More than 150 ERCPs were performed in each center per year by a single operator or by a team of no more than three endoscopists. RESULTS: Two thousand four hundred sixty-two procedures were performed; 18 patients were discharged because the papilla of Vater was not reached (duodenal obstruction, previous gastrectomy, etc.). Two thousand four hundred forty-four procedures were considered in 2103 patients. Overall complications occurred in 121 patients (4.95% of cases): pancreatitis in 44 patients (1.8%), hemorrhage in 30 (1.13%), cholangitis in 14 (0.57%), perforation during ES in 14 (0.57%), and others in 14 (0.57%); deaths occurred in three patients (0.12%). In multivariate analysis, the following were significant risk factors: a) for pancreatitis, age (< or = 60 yr), use of precutting technique, and failed clearing of biliary stones, and b) for hemorrhage, precut sphincterotomy and obstruction of the orifice of the papilla of Vater. CONCLUSIONS: The results of our study further contribute to the assessment of risk factors for complications related to ERCP/ES. It is crucial to identify high risk patients to reduce complications of the procedures.

A proposal for intraoperative washout of colon for the endoscopic diagnosis of the lower gastrointestinal tract haemorrhage.

The authors refer about a proposal for an intraoperative wash-out of colon in order to improve the endoscopic diagnosis of the bleeding's precise site in case of lower gastrointestinal tract haemorrhage. The colonic wash-out is obtained by the transanal insertion of a Baker type silicone tube this is guided by the surgeon up to the caecum followed by the insertion of the colonoscope. This method turned out useful in one case of haemorrhagic shock.

Cirrhosis: diagnosis with sonographic study of the liver surface.

To find an objective sonographic sign of cirrhosis, the authors used a small-parts probe to examine the liver surface for irregularities that corresponded to those of nodular regeneration. Fifty healthy subjects were examined to assess the pattern of a sonographically normal-appearing liver surface. A second group of 75 patients, mainly with suspected diffuse chronic liver disease, was examined with particular attention to the most commonly described sonographic signs of cirrhosis, and laparoscopy and biopsy were also performed. The liver surface was examined in a third group of 225 patients with cancer in whom metastases had been demonstrated sonographically. A diagnosis of cirrhosis was made with sonography when surface irregularities were observed that were comparable to the anatomic abnormalities of a cirrhotic liver surface. An examination of the liver surface gave the best diagnostic rate for cirrhosis (88%). There were seven false-negative results, but in five of them no surface nodularity could be seen at laparoscopy, and the diagnosis was made only on the basis of histologic studies; there was one false-positive result. This study indicated that ultrasonography might be a reliable method to follow up patients with chronic liver disease that may progress to cirrhosis.

Effect of sulpiride on serum gastrin in duodenal ulcer.

The effect of N-ethyl-2(2-methoxy-5-sulfamido-benzamidomethyl-pyrrolidine (sulpiride, Dobren) on serum gastrin in patients with duodenal ulcer was evaluated. A statistically significant decrease in gastrinemia was observed. The possible mode of action of sulpiride is discussed. It is suggested that sulpiride by acting on the hypothalamus could possibly normalize the alterations of the mucosal barrier and restore the feed-back mechanism implicated in the autoregulation of antral gastrin secretion.