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.

A multi-centre North Italian prospective survey on some quality parameters in lower gastrointestinal endoscopy.

BACKGROUND AND AIM: To record prospectively, in a multi-centre survey, the adherence to some quality parameters of lower digestive endoscopy in everyday practice, focusing in particular on sedation and monitoring; choice of extension of endoscopic examination by the operator and relative performance in intubation of the caecum; behaviour, in some particular clinical circumstances, such as fresh haematochezia, screening and surveillance situations, functional symptoms, management of polyps. PATIENTS AND METHODS: Twenty-five centres located in Lombardia, Italy took part in the study; the duration of the survey was 2 weeks. 1,406 consecutive cases were recorded. RESULTS: The main indications to colonoscopy were fresh haematochezia (21%). abdominal pain (11.7%) and surveillance after surgery for tumours or endoscopic polyp removal (24.3%). Screening examinations accounted for 7.1% of all examinations. Conscious sedation was administered in 63.9% of patients; pulse oxymetry and cardiac frequency monitoring was used in 44.2% of cases. Total colonoscopy was planned in 84.2% of cases; the actual rate of intubation of the caecum in the cases submitted to the procedure was 84.1%. Normal results were obtained in 24.3%. In 24.3% of patients, one or more polyps were identified; 84.2% of these were removed during the first examination. Four complications (accounting for 0.28% of cases) were recorded, all after polypectomy and all successfully treated conservetively. CONCLUSIONS: The present study has shown that some attitudes in lower digestive endoscopy are sub-optimal: in particular, screening examinations are still infrequent; conscious sedation and monitoring have probably been used too rarely; intubation of the caecum was achieved in <90% of cases; the endoscopic removal of many polyps has been delayed for unexplained reasons. On the other hand, timing of surveillance after surgery for tumours or endoscopic removal of polyps has, overall, been adequate; the rate of normal examinations and the rate of complications have been satisfactorily low.

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.

Prospective randomized trial comparing Tannenbaum Teflon and standard polyethylene stents in distal malignant biliary stenosis.

BACKGROUND: Our aim was to compare the clinical efficacy of the Tannenbaum (TB) biliary prostheses, a recently designed Teflon stent without side holes, with the Cotton-Huibregtse (CH) polyethylene stent. METHODS: Fifty-seven patients (26 men, mean age 75.5 years) with unresectable malignant tumors and distal biliary stenosis were included (38 pancreatic head cancer, 17 cholangiocarcinoma, 2 ampullary cancer). Patients were prospectively randomized to have a 10F, 7 cm long TB (29 patients) or CH (28 patients) stent inserted endoscopically. Four patients (2 TB and 2 CH) were excluded: 3 because of the failure of stent insertion and 1 because of a protocol violation. The patients were evaluated clinically and, if necessary, with biochemical tests every month until death or until they needed surgery for symptoms of gastric outlet obstruction. When occlusion or dislocation occurred, the stent was replaced with one of the same type. Cumulative stent patency and patient survival were estimated with the Kaplan-Meier life-table analysis and compared by log-rank chi-square test. RESULTS: The two groups were comparable in mean age, gender, and diagnosis. The patients were followed for a mean of 145.5 days (range 24 to 613); by the end of the study 47 patients (81%) had died or developed symptoms of gastric outlet obstruction. Median survival was 88 days (range 24 to 613) in the TB group and 75.6 days (23 to 486) in the CH group. Stent exchange (occlusion 16, dislocation 3) was necessary for 5 patients in the TB group and 7 in the CH group. No statistical difference was found on comparing the mean duration of function of the first, second, and third stents (analysis of variance, p = 0.80). The median duration of stent function was 96 days (range 11 to 613) in the TB group and 75.5 days (range 23 to 323) in the CH group. No significant difference was found in either survival time (p = 0.48) or stent patency (p = 0.12). CONCLUSION: This study found no significant advantage of the Tannenbaum prostheses over the standard polyethylene stent in the palliation for patients with distal malignant biliary stenosis with regard to survival or length of stent patency.

Are we correctly using the inhibitors of gastric acid secretion and cytoprotective drugs? Results of a multicentre study.

AIM: To evaluate indications and frequency of prescriptions of pH-modifying and cytoprotective drugs in hospital departments. DESIGN OF THE STUDY: Multicentre cohort transverse relevation. MATERIALS AND METHODS: On a randomly selected day the clinical charts of 3685 inpatients were reviewed by a gastroenterologist and data were collected concerning the drug used, its dosage and indications for the prescription. RESULTS: 26.8% of hospitalized patients were under treatment on the day of the study. Ranitidine was the most frequently prescribed (73.9%). The purpose of treatment was cure of acute disease or symptoms in 27% of cases and prevention of peptic damage in 73%. Fear of development of stress mucosal lesions (28%) and therapy with other drugs (56%) motivated prophylactic treatment in the majority of cases. The examination of clinical charts failed to demonstrate any need for treatment in 51.4% of the patients. Disparities in the frequency of prescription between different departments and hospitals were found. CONCLUSION: Criteria used for prescription of drugs for peptic diseases in hospitalized patients should be strictly monitored to avoid excessive and unmotivated use also in general practice.

First bleeding episode from oesophageal varices in cirrhotic patients: a prospective study of endoscopic predictive factors.

Two hundred patients affected by liver cirrhosis and oesophageal varices were studied in 9 Gastrointestinal Units in Lombardy (Northern Italy) in order to assess factors possibly related to variceal bleeding. Only patients without any previous episode of gastrointestinal bleeding were included in the prospective evaluation. For each patient demographic data, aetiology of cirrhosis, various clinical and biochemical parameters able to group patients into the three Child-Pugh Classes, endoscopic items for calculation of Beppu's and of NIEC prognostic scores were recorded on computerized cards. Patients were regularly interviewed every three months for one year and underwent an upper gastrointestinal endoscopy at enrollment, after six months and in case of bleeding. Within the twelve-month follow-up period, 29 out of the 200 patients (14%) bled and 52 out of 200 died (26%). In 16 of the 52 patients who died (59% of bleeding patients) death was directly related to gastrointestinal bleeding. Bleeding from oesophageal varices was endoscopically proven in 19/29 patients, in another 9 bleeding was classified as from unknown source and in one patient a bleeding gastric ulcer was diagnosed. Univariate analysis of all the recorded clinical, biochemical and endoscopic parameters, performed by Chi-square method and Fisher exact test showed that the presence of RWM (p < 0.001) was the only factor significantly associated to variceal bleeding within one year. Relationship between size of varices and bleeding was very close to the statistical significance but did not achieve it (p = 0.058).

Biphasic diurnal periodicity in bleeding from peptic ulcer.

OBJECTIVE: To evaluate if there was periodicity in the manifestations of gastrointestinal bleeding (hematemesis and melena). METHOD: This is a multicenter prospective study carried out in the Endoscopy Units of eight hospitals. At the time of the emergency endoscopy, the following data were collected: age, sex, endoscopic diagnosis, solar hour of the first hematemesis (vomiting of bright red or tarry black material) and of the first melena (black or bloody soft stools), and any drugs taken during the week before the bleeding episode, regardless of the dose. RESULTS: 806 patients were studied. Bleeding was from peptic ulcer in 405 patients (50%), from esophageal varices in 197 (24%), and from other sources in the remainder. Analysis using single cosinor statistics showed a nonrandom distribution in bleeding from peptic ulcer, whether presenting first with hematemesis (p = 0.02) or melena (p = 0.03). There were two peaks at 6:45 AM and 6:45 PM for hematemesis and at 7:25 AM and 7:25 PM for melena, representing a biphasic diurnal (ultradian) rhythm. CONCLUSIONS: This study shows that bleeding due to peptic ulcer has a biphasic diurnal periodicity. This has potential importance for the pathogenesis of bleeding, for the management of gastrointestinal hemorrhage and the administration of drugs known to cause peptic ulcer bleeding.

Clinical significance of gastric dysplasia: a multicenter follow-up study. Gastrointestinal Endoscopic Pathology Study Group.

The evolution of gastric moderate and severe dysplasia was examined in a prospective multicenter study. One-hundred-and-nine of 141 patients with the endoscopic-bioptic diagnosis of moderate or severe dysplasia had an adequate follow-up and were included into the study. After revision of the initial slides by a gastrointestinal pathologist, 57 patients whose lesions did not meet the histological criteria for dysplasia were excluded, being reclassified as hyperplastic or metaplastic lesions (group 2). The 52 patients with confirmed moderate or severe dysplasia (group 1) were followed up for at least six months or underwent surgery for confirmed dysplasia or cancer. Thirty-two cancers were found in group 1 (33% in patients with moderate and 81% in patients with severe dysplasia). Among them, about half (n = 17) were early gastric cancers. Neither severe dysplasia nor cancer were found during the follow-up in group 2. Mean follow-up time was 13 months in group 1 and 16 months in group 2. Our results indicate that: 1) Confirmed moderate dysplasia shows a high risk of cancer development and requires strict bioptic follow-up; 2) Surgery is indicated in confirmed severe gastric dysplasia seen in the early detection of gastric cancer.

Action of glucomannans on complaints in patients affected with chronic constipation: a multicentric clinical evaluation.

Chronic constipation is a very frequent disease in western countries but fibres can often solve the problem. In the present study, authors tested the efficacy and the acceptability of glucomannans, hydrophylic carbohydrates with a high degree of viscosity, in 93 patients affected with chronic constipation. The multicentric, open and non-controlled study was divided into an initial phase (treatment with 1g of glucomannans t.i.d. for 1 month) and a maintenance phase (1g b.i.d. for one month). We evaluated both objective parameters (number of days per week with bowel movements and number of enemas) and abdominal symptoms. After one month all assessed parameters showed a statistically significant improvement lasting through the second month. Glucomannans were well accepted and devoid of relevant side-effects. In conclusion, considering their efficacy and tolerability, they can be proposed as an ideal therapeutic tool in the management of chronic constipation symptoms.

Ranitidine vs metoclopramide in the medical treatment of reflux esophagitis.

45 patients with symptomatic reflux esophagitis were randomly treated with either Ranitidine (150 mg b.i.d.) or Metoclopramide (10 mg t.i.d.) for six weeks. The severity of dyspeptic symptoms and the grade of endoscopic and histological esophagitis were assessed before and after treatment. Both drugs proved significantly effective in inducing symptomatic and endoscopic improvement, but Ranitidine appeared significantly superior in promoting disappearance or improvement of endoscopic esophagitis. Moreover Ranitidine was found to significantly reduce the severity of histological changes, whereas Metoclopramide was unable to do so.

[Analysis of membrane proteins in pernicious anemia and various primary and secondary erythropathies]. / Analisi delle proteine di membrana nell'anemia perniciosa ed in alcune eritropatie primitive e secondarie

A study of membrane proteins in pernicious anaemia and other haemolitic and anhaemolytic erythropathies is reported. Cellulose acetate and acrylamide gel electrophoresis was carried out and acid, neutral and basic amino acid contents were determined. Relatively specific alterations were noted. Chromatographic analysis of the amino acids suggested that in pernicious anaemia, as in other conditions, structural changes take place in the red cell membrane, though these may be confined to certain sectors. A constant alteration related to the concomitance or otherwise of erythrocyte hyperhaemolysis, however, could not be discerned.

[Erythrocyte changes of membrane proteins in some hemoglobinopathies]. / Alterazioni eritrocitarie delle proteine di membrana in alcune emoglobinopatie

The electrophoretic behaviour of red cell membrane proteins was studied in thalassaemia major and minor and in sickle-cell anaemia. Protein amino acid composition was also determined following hot hydrolysis of the stromas. Experiments with various solubilisation methods, electrophoresis supports and buffers showed certain changes in these three diseases, accompanied by alterations of the percent ratio of some amino acids.

[Changes in membrane proteins in the erythrocytes of patients with hemolymphoblastosis not directly involving the erythroblastic line]. / Alterazione delle proteine di membrana negli eritrociti di soggetti con emolinfoblastosi non interessanti direttamente la linea eritoblastica

An analysis of red cell membrane proteins in acute and chronic lymphatic leukaemia, Hodgkin's disease, lymphosarcoma, and myeloma was carried out. The electrophoretic pattern after solubilisation in urea or SDS was examined, along with migration on cellulose acetate or acrylamide in different buffers. Protein acid, basic and neutral amino acid percentages were also determined. An increase in low molecular weight and faster anodic migration proteins was noted in the lymphoblastoses, whereas the amino acid spectrum of these proteins showed percent changes in the case of some amino acids, particularly glutamic acid, phosphoserine, lysine and histidine. The alterations observed were compared with those noted previously in other haemoblastoses, congenital haemolytic and anhaemolytic blood diseases, and endoglobular or acquired metabolic defects in a closer assessment of their significance.

[Changes in the proteins of erythrocyte membrane in polycythemia vera]. / Alterazioni delle proteine di membrana negli eritrociti della policitemia vera

Red cell membrane protein behaviour was studied in patients with polycythaemia vera, polyglobulia secondary to cardiorespiratory disorders, chronic myeloid leukaemia and acute granuloblastic leukaemia. Electrophoretic pictures were examined after solubilisation in urea or SDS and on various supports. Chromatographic analysis was also made of acid, neutral and basic amino acids obtained by hot-acid hydrolysis of the stromas. Protein electrophoretic changes in polycythaemia differed from those observed in granuloblastic leukaemia and chronic cor pulmonale. Different stromal protein amino acid percents were also noted, with marked variations between each disease.