Resect and discard strategy in clinical practice: a prospective cohort study.

BACKGROUND AND STUDY AIMS: Narrow-band imaging (NBI) has shown promising results in discriminating adenomatous from non-adenomatous colonic polyps. In patients with small polyps (< 10  mm), the application of NBI within a "resect and discard" strategy, might allow post-polypectomy surveillance intervals to be determined independently from histopathology. The aim of the present study was to assess the feasibility and safety of this approach in routine clinical practice. PATIENTS AND METHODS: Consecutive colonoscopy outpatients with one or more polyps smaller than 10  mm were prospectively included. Each polyp was categorized by the endoscopist as adenoma or non-adenoma according to simplified NBI criteria, and future post-polypectomy surveillance interval was assigned accordingly. Following histopathology, post-polypectomy surveillance interval was subsequently re-assigned, and the accordance between endoscopy- and histology-directed surveillance strategies was calculated. RESULTS: Among 942 colonoscopy patients, 286 (30.4 %) with only small polyps were included. In total, 511 small polyps were evaluated; 350 (68.5 %) were adenomas and 18 of these (5.1 %) had histologic features of advanced neoplasia. For the in vivo diagnosis of adenoma, NBI sensitivity, specificity, accuracy, and positive and negative likelihood ratios were 94.9 %, 65.8 %, 85.7 %, 2.80, and 0.08, respectively. The endoscopy-directed surveillance strategy was in accordance with the histology-directed strategy in 237 of 286 patients (82.9 %). In 9.8 % and 7.3 % patients, the endoscopy-directed approach would have resulted in early and delayed surveillance, respectively. CONCLUSIONS: The resect and discard strategy seems to be a viable, safe, and cost-effective approach for the management of patients with small polyps. However, caution in the application of the strategy should be advocated for patients with polyps 6 - 9  mm in size and those with right-sided lesions, due to their malignant potential. The study was registered on Clinicaltrials.gov (NCT01462123).

Removal of infused water predominantly during insertion (water exchange) is consistently associated with a greater reduction of pain score - review of randomized controlled trials (RCTs) of water method colonoscopy.

INTRODUCTION: Variation in the outcomes in RcTs comparing water-related methods and air insufflation during the insertion phase of colonoscopy raises challenging questions regarding the approach. This report reviews the impact of water exchange on the variation in attenuation of pain during colonoscopy by water-related methods. METHODS: Medline (2008 to 2011) searches, abstracts of the 2011 Digestive Disease Week (DDW) and personal communications were considered to identify RcTs that compared water-related methods and air insufflation to aid insertion of the colonoscope. Results: Since 2008 nine published and one submitted RcTs and five abstracts of RcTs presented at the 2011 DDW have been identified. Thirteen RcTs (nine published, one submitted and one abstract, n=1850) described reduction of pain score during or after colonoscopy (eleven reported statistical significance); the remaining reports described lower doses of medication used, or lower proportion of patients experiencing severe pain in colonoscopy performed with water-related methods compared with air insufflation (Tables 1 and 2). The water-related methods notably differ in the timing of removal of the infused water - predominantly during insertion (water exchange) versus predominantly during withdrawal (water immersion). Use of water exchange was consistently associated with a greater attenuation of pain score in patients who did not receive full sedation (Table 3). CONCLUSION: The comparative data reveal that a greater attenuation of pain was associated with water exchange than water immersion during insertion. The intriguing results should be subjected to further evaluation by additional RcTs to elucidate the mechanism of the pain-alleviating impact of the water method.

Removal of infused water predominantly during insertion (water exchange) is consistently associated with an increase in adenoma detection rate - review of data in randomized controlled trials (RCTs) of water-related methods.

INTRODUCTION: Variation in outcomes in RcTs comparing water-related methods and air insufflation raises challenging questions regarding the new approach. This report reviews impact of water exchange - simultaneous infusion and removal of infused water during insertion on adenoma detection rate (ADR) defined as proportion of patients with a least one adenoma of any size. METHODS: Medline (2008-2011) searches, abstract of 2011 Digestive Disease Week (DDW) meeting and personal communications were considered to identify RcTs that compared water-related methods and air insufflation to aid insertion of colonoscope. RESULTS: Since 2008, eleven reports of RcTs (6 published, 1 submitted and 4 abstracts, n=1728) described ADR in patients randomized to be examined by air and water-related methods. The water-related methods differed in timing of removal of the infused water -predominantly during insertion (water exchange) (n=825) or predominantly during withdrawal (water immersion) (n=903). Water immersion was associated with both increases and decreases in ADR compared to respective air method patients and the net overall change (-7%) was significant. On the other hand water exchange was associated with increases in ADR consistently and the net changes (overall, 8%; proximal overall, 11%; and proximal <10 mm, 12%) were all significant. CONCLUSION: Comparative data generated the hypothesis that significantly larger increases in overall and proximal colon ADRs were associated with water exchange than water immersion or air insufflation during insertion. The hypothesis should be evaluated by RCTs to elucidate the mechanism of water exchange on adenoma detection.

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.

Effectiveness of a continuous quality improvement program on colonoscopy practice.

BACKGROUND AND STUDY AIM: Continuous quality improvement (CQI) is recommended by professional societies as part of every colonoscopy program, but little is known with regard to its effectiveness for colonoscopy outcomes. We prospectively assessed whether the implementation of a CQI program in routine clinical practice influences the quality performance of colonoscopy. METHODS: In an open-access endoscopy unit at a secondary care center in Northern Italy, 6-monthly audit cycles were carried out over a 4-year period, to identify reasons for poor colonoscopy outcomes and institute appropriate changes to improve performance. The colonoscopy completion rate and the polyp detection rate as detected by endoscopists were considered to be key measures for improvement. RESULTS: The initial crude colonoscopy completion rate was 84.6%, with a range for individual endoscopists 80.4%-94%. Four endoscopists had a completion rate lower than 90%. The overall polyp detection rate was 34%, with a wide variation among endoscopists (range 14%-42%). Poor patient tolerance and differences in colonoscopist expertise were the main determinants of lack of completion and variation in polyp detection rate. Changes to sedation practice, greater access to endoscopy sessions for the endoscopists with the lowest performance rates, and other organizational arrangements, were implemented to improve quality performance. The crude completion rates improved consistently, up to 93.1%, over the study period. This trend was confirmed even when adjusted completion rates were calculated. All endoscopists reached a crude completion rate of 90% or more and a polyp detection rate of over 20%. The introduction of CQI did not significantly change the overall incidence of procedure-related complications. CONCLUSIONS: The effectiveness of colonoscopy can be improved by implementing a CQI program in routine colonoscopy practice.

Is the supine position as safe and effective as the prone position for endoscopic retrograde cholangiopancreatography? A prospective randomized study.

BACKGROUND AND STUDY AIMS: Endoscopic retrograde cholangiopancreatography (ERCP) is usually performed with the patient lying in the prone position, on the assumption that this position is optimal for cannulation of the papilla and for obtaining good-quality radiographic images. The supine position, however, may be more comfortable for the patient and may facilitate airway management, and this study aimed to compare the two positions in terms of procedure outcome, safety, and patient tolerance. PATIENTS AND METHODS: Consecutive patients who were undergoing ERCP were randomized to start the procedure in either the prone position or the supine position. Patients under the age of 18 years, intubated patients, and those who had already undergone endoscopic sphincterotomy were excluded. The difficulty of cannulation was assessed using the Freeman score (1=one to five attempts; 2=six to 15 attempts; 3=more than 15 attempts; 4=failure of cannulation). Total procedure time, patient tolerance, willingness to undergo ERCP in the future, and procedure-related adverse cardiorespiratory events (oxygen desaturation, tachycardia, bradycardia) were also recorded. RESULTS: A total of 34 patients were evaluated (21 men, 13 women; mean age 68, range 20-96), 17 patients in each group. Demographic and clinical features, and the indications for the procedure were similar for the two patient groups. The median Freeman score was significantly lower in the prone group compared with the supine group (1 vs. 3, P=0.0047, rank sum test). Biliary cannulation was achieved in all patients in the prone group, but was not achieved in five patients (29%) in the supine group (P=0.052). In four of these five patients, biliary cannulation was successfully achieved after turning the patient into the prone position. The percentage of patients unwilling to repeat the ERCP procedure in the future was higher in the supine group (29% vs. 6%, P=0.087); the mean tolerance score and mean total procedure time were similar in the two groups. Seven patients in the supine group experienced at least one adverse cardiorespiratory event, compared with only one patient in the prone group (41% vs. 6%, P=0.039). CONCLUSIONS: ERCP performed with the patient in the supine position is technically more demanding for operators used to working with patients in the prone position and carries a greater risk of adverse cardiorespiratory events in nonintubated patients.

Ischemic colitis associated with rofecoxib.

Rofecoxib is a selective cyclooxygenase-2 inhibitor that has been approved for the treatment of osteoarthritis and management of acute pain. Recent debate has emerged regarding the prothrombotic potential and the cardiovascular safety of this new drug, especially at doses greater than 25mg. We describe two extensively investigated cases of self-limited ischemic colitis in patients who were briefly treated with 50mg rofecoxib daily for acute pain. In both cases, the onset of symptoms correlated temporally with rofecoxib use and symptoms abated with drug discontinuation. There was no evidence of other possible causes of colon ischemia. A causal relationship between the start of rofecoxib treatment and the colon ischemia cannot be definitely established on the basis of the evidence, but the temporal relationship is striking and the pathophysiological rationale could be founded.

Routine versus "on demand" sedation and analgesia for colonoscopy: a prospective randomized controlled trial.

BACKGROUND: The safety and tolerance of routine sedation and analgesia versus "on demand" sedation were compared in patients undergoing colonoscopy. METHODS: Two hundred forty-nine outpatients were randomly assigned to one of two groups. Group A (n = 125) received midazolam, 0.07 mg/kg intravenously plus meperidine, 0.77 mg/kg intravenously immediately preceding the colonoscope insertion. Group B (n = 124) received the same medication upon request during the procedure. Tolerance was assessed 24 hours later by phone interview performed by a nurse blinded to the medication regimen administered. RESULTS: Eighty-three patients (66%) in Group B required sedation during colonoscopy. Among men in Group B more than 60 years of age, only 23% required sedation. The proportion of patients reporting moderate or severe pain (34% vs. 12.1%, p < 0.001) and of those stating they would not be willing to undergo colonoscopy again in the future (22% vs. 9.7%, p < 0.005) was significantly higher in the "on demand" sedation group. By multivariate analysis the randomization group was the single variable independently associated with both such outcomes. The frequency of side effects was similar in the two groups. CONCLUSIONS: Administration of sedative and analgesic drugs routinely before colonoscopy is superior to "on demand" sedation in terms of tolerance and is not associated with an increase in side effects.

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.

Quality assurance and colonoscopy.

BACKGROUND AND STUDY AIMS: Little is known concerning the usefulness and feasibility of quality assurance programs in gastrointestinal departments. The aim of this study was to identify the indicators of quality in colonoscopy, to check their use in clinical practice, and to identify their threshold values. MATERIALS AND METHODS: A prospective study was performed in four endoscopic units. In the first phase, a questionnaire was used to identify the indicators that were considered important and easy to record; in the second phase, the selected items were prospectively recorded. RESULTS: Data from 603 colonoscopies were evaluated. The selected indicators were: rate of cecal intubation, rate of examinations with normal findings, rates of complications, appropriateness of indications, use of a washing machine for disinfection, duration of the disinfection procedure, rate of procedures repeated due to poor colon cleansing, rate of operative procedures, length of waiting time, rate of procedures performed for follow-up of known disease, experience of the operator, and rate of procedures performed with the patient under conscious sedation. A striking difference emerged between the technical standards at three centers, which were fairly good, and the standard at the fourth center, which was less satisfactory. The length of the waiting time was high in all centers, as well as the rate of examinations conducted with an inappropriate indication. The rate of procedures performed under conscious sedation varied widely between the centers. CONCLUSIONS: The study of the indicators of quality of colonoscopy is feasible and easy to perform in clinical practice, and can be useful for quality assurance programs.

Acute self-limiting jejunitis as the first manifestation of microscopic polyangiitis associated with Sjogren's disease: report of one case and review of the literature.

We report a case of acute self-limiting ulcerative jejunitis of unknown aetiology in a 72-year-old female patient in which a subsequent diagnosis of microscopic polyangiitis and Sjogren's syndrome was made. All known causes of jejunal ulceration and inflammation were excluded. Previously reported cases of acute self-limiting jejunitis are reviewed and the possibility that acute jejunitis in this patient had been the first manifestation of systemic vasculitis is discussed.

Granulomatous gastritis presenting as gastric outlet obstruction: a case report.

The clinico-pathologic entity of idiopathic granulomatous gastritis is a form of granulomatous gastritis, distinct from Crohn's disease, sarcoidosis, infections, foreign bodies, malignancy or vasculitis. The case of a 61-year-old female is described who was admitted on account of progressive weight loss, diffuse abdominal pains, post-prandial vomiting. Gastroscopy revealed a pyloric stenosis managed surgically. Pathological examination of the resected stomach showed numerous non-caseating granulomas in the lamina propria. No definite aetiological factor could be detected. A diagnosis of idiopathic granulomatous gastritis was made. She remains well 5 years later and has not developed regional enteritis, sarcoidosis, or any other generalized diseases.

Congenital short pancreas. Report of a new case observed during the course of a recurrent acute pancreatitis.

A new case of congenital short pancreas (partial agenesis or hypoplasia of the dorsal pancreas) is reported. The patient was a 61-year-old caucasian man, referred for two episodes of non-severe acute biliary pancreatitis. Clinical and laboratory findings and the presence of ultrasound biliary sludge in the gallbladder supported the biliary origin of pancreatitis. Computerized tomography revealed a slightly enlarged and hypodense head of the gland but could not identify any pancreatic tissue in the region of the body and tail. Endoscopic retrograde pancreatography showed a short pancreas with a duct system in communication both with the accessory and main papilla. Laparoscopic cholecystectomy was performed and no further episodes of abdominal pain occurred. Short pancreas is a rare congenital abnormality consisting in the parenchyma and ductal system restricted to the head with some residual dorsal tapering and arborizing ducts communicating with the minor papilla. This anomaly can be an incidental finding and its association with episodes of recurrent pancreatitis needs to be proven.

Randomized study comparing omeprazole plus amoxycillin versus omeprazole plus clarithromycin for eradication of Helicobacter pylori.

BACKGROUND: Dual therapy with omeprazole plus amoxycillin or with omeprazole plus clarithromycin has been proposed for eradication of Helicobacter pylori. The main problem is the great variability in the rate of eradication. METHODS: A group of 287 consecutive patients with active peptic ulcers and H. pylori infections were admitted to a prospective, randomized, multicentre study, to be given omeprazole 20 mg b.d. plus either amoxycillin 1 g b.d. or clarithromycin 500 mg t.d.s. for 2 weeks. Cure was defined as the absence of H. pylori infection, 4-6 weeks after completing anti-microbial therapy, assessed by urease activity and histology of antral and body gastric biopsies. RESULTS: The bacteria were eradicated in 68/143 patients (48%) treated with amoxycillin and omeprazole and 70/144 patients (49%) treated with clarithromycin and omeprazole (intention-to-treat analysis). The ulcers were healed in 118/127 patients (93%) treated with amoxycillin and in 115/123 (94%) of those treated with clarithromycin. Undesirable effects were rare with both treatments. CONCLUSIONS: Combined treatment with omeprazole plus either amoxycillin or clarithromycin produced a high percentage of short-term healing of ulcers and was well tolerated, but is not useful as first-line anti-Helicobacter pylori treatment.