Colo-rectal endoscopic full-thickness resection (EFTR) with the over-the-scope device (FTRD®): A multicenter Italian experience.

BACKGROUND AND AIM: Endoscopic full-thickness resection(EFTR) with FTRD® in colo-rectum may be useful for several indications.The aim was to assess its efficacy and safety. MATERIAL AND METHODS: In this retrospective multicenter study 114 patients were screened; 110 (61M/49F, mean age 68 ±â€¯11 years, range 20-90) underwent EFTR using FTRD®. Indications were:residual/recurrent adenoma (39), incomplete resection at histology (R1 resection) (26), non-lifting lesion (12), adenoma involving the appendix (2) or diverticulum (2), subepithelial lesions(10), suspected T1 carcinoma (16), diagnostic resection (3). Technical success (TS: lesion reached and resected), R0 resection (negative lateral and deep margins),EFTR rate(all layers documented in the specimen) and safety have been evaluated. RESULTS: TS was achieved in 94.4% of cases. EFTR was achieved in 91% with lateral and deep R0 resection in 90% and 92%. Mean size of specimens was 20 mm (range 6-42). In residual/recurrent adenomas, final analysis revealed: low-risk T1 (11), adenoma with low-grade dysplasia (LGD) (24) and high-grade dysplasia (HGD) (3), scar tissue (1). Histology reports of R1 resections were: adenoma with LGD (6), with HGD (1), low-risk (6) and high-risk (1) T1, scar tissue (12). Non-lifting lesions were diagnosed as: adenoma with HGD (3), low-risk (7) and high risk (2) T1. Adverse clinical events occurred in 12 patients (11%),while adverse technical events in11%. Three-months follow-up was available in 100 cases and residual disease was evident in only seven patients. CONCLUSIONS: EFTR using FTRD® seems to be a feasible, effective and safe technique for treating selected colo-rectal lesions. Comparative prospective studies are needed to confirm these promising results.

Development of an E-learning System for the Endoscopic Diagnosis of Early Gastric Cancer: An International Multicenter Randomized Controlled Trial.

BACKGROUND: In many countries, gastric cancer is not diagnosed until an advanced stage. An Internet-based e-learning system to improve the ability of endoscopists to diagnose gastric cancer at an early stage was developed and was evaluated for its effectiveness. METHODS: The study was designed as a randomized controlled trial. After receiving a pre-test, participants were randomly allocated to either an e-learning or non-e-learning group. Only those in the e-learning group gained access to the e-learning system. Two months after the pre-test, both groups received a post-test. The primary endpoint was the difference between the two groups regarding the rate of improvement of their test results. FINDINGS: 515 endoscopists from 35 countries were assessed for eligibility, and 332 were enrolled in the study, with 166 allocated to each group. Of these, 151 participants in the e-learning group and 144 in the non-e-learning group were included in the analysis. The mean improvement rate (standard deviation) in the e-learning and non-e-learning groups was 1·24 (0·26) and 1·00 (0·16), respectively (P<0·001). INTERPRETATION: This global study clearly demonstrated the efficacy of an e-learning system to expand knowledge and provide invaluable experience regarding the endoscopic detection of early gastric cancer (R000012039).

Zenker's diverticulum: exploring treatment options.

Zenker's diverticulum is an acquired sac-like outpouching of the mucosa and submucosa layers located dorsally at the pharyngoesophageal junction through Killian's dehiscence. It is the most common type of oesophageal diverticula with a reported prevalence ranging between 0.01 to 0.11% and typically occurs in middle-aged and elderly patients. Predominant symptoms are dysphagia and regurgitation. Treatment is recommended for symptomatic patients and considering the aetiopathogenesis of the disease demands myotomy of the cricopharyngeal muscle. Myotomy may be pursued through either open surgical or endoscopic techniques. Management of Zenker's diverticulum has dramatically progressed during past decades. Open surgery with cricopharyngeal myotomy has long been the conventional treatment with satisfactory results, but is associated with high complication rates. Since Zenker's diverticulum mainly affects frail elderly patients, less invasive treatments are indicated. In recent years, endoscopic repair of Zenker's diverticulum has been found to be a viable safe and effective alternative to surgery and gained widespread acceptance. Endoscopic stapled diverticulotomy is generally the preferred approach, but flexible endoscopy is a valuable option, particularly for high-risk patients. The literature is mainly based on retrospective case series or comparative case series, and the optimal treatment modality has not yet been established. The choice between the different approaches depends on local expertise and preferences. Based on retrospective literature results, appropriate technique selection dictated by the size of the diverticulum and the patient's conditions is however desirable.

Endoscopic gallbladder drainage for acute cholecystitis: technical and clinical results.

BACKGROUND AND STUDY AIMS: Cholecystectomy is the standard treatment for acute cholecystitis while percutaneous drainage is reserved for high-risk patients. The aim of the present study was to assess the technical success rate and clinical efficacy of endoscopic gallbladder drainage in patients with acute cholecystitis. PATIENTS AND METHODS: A total of 35 consecutive patients with acute cholecystitis and without residual common bile duct obstruction were retrospectively identified. Patients were stratified according to the pathogenesis and stages of acute cholecystitis, and the morphology of the cystic duct and/or its insertion in the common bile duct. Primary outcomes were technical success and early and late clinical success. RESULTS: Endoscopic retrograde cholangiopancreatography (ERCP) was performed within the first 72 hours in 19 patients (54%). Technical success was achieved in 29 patients (83%); drainage was nasocholecystic in 21 of these (72%), plastic stenting in 6 (21%), and a combined method in 2 (7%). The pathogenesis and stage of acute cholecystitis, and the morphology both of the cystic duct and its insertion in the common bile duct, did not influence technical success. Clinical success was achieved in 24 cases (83%) after a median of 3 days (range 2-12). Four patients (14%) died within 3 days due to septic complications, and one accidentally removed the nasocholecystic drain after 24 hours. Late results, available in 21 patients after a median follow-up of 17 months, showed relapse of acute cholecystitis in 2 (10%) (both with stents) and of biliary pain in 2 patients (10%), both of whom had nasocholecystic drainage. CONCLUSIONS: Endoscopic gallbladder drainage seems feasible and effective in resolving acute cholecystitis, but only as a temporary measure because of a 20% relapse rate in long-term follow-up. Prospective studies are necessary to identify which patients would benefit most from this endoscopic technique in the short and long term.

Combined endoscopic stent insertion in malignant biliary and duodenal obstruction.

BACKGROUND AND STUDY AIMS: Self-expandable metal stents (SEMS) are an effective palliative treatment for malignant biliary and duodenal strictures. Combined biliary and duodenal stenting remains a technical challenge, however. The aim of this study was to evaluate the technical feasibility of an endoscopic approach to double stenting of malignant biliary and duodenal strictures. PATIENTS AND METHODS: Consecutive patients referred for palliative gastroduodenal and biliary stenting were followed up prospectively. Patients' demographic characteristics, the site and nature of the strictures, success rates, complications, and survival time were recorded. RESULTS: A total of 64 patients underwent double stenting. In 46 patients, biliary obstruction occurred before the onset of duodenal obstruction (by a median of 107 days) (group 1); in 14 patients, biliary obstruction occurred concurrently with duodenal obstruction (group 2); and in four patients the duodenal obstruction preceded the biliary obstruction (by a median of 121 days) (group 3). The duodenal strictures were proximal to the papilla in 31 patients, adjacent to the papilla in 25 patients and distal to the papilla in eight patients. The majority of biliary strictures were in the middle or distal third of the bile duct (in 52/64 patients). Duodenal SEMS were successfully deployed in all patients. Combined endoscopic stenting was successful in 100% of patients in group 1, 86% of patients in group 2, and in 100% of patients in group 3. Taking the three groups together, early complications occurred in 6% of patients and late complications occurred in 16% of patients. The overall median survival after combined stenting was 81 days (range 2-447 days). CONCLUSIONS: Combined endoscopic biliary and duodenal SEMS insertion is safe and effective for palliation in malignant biliary and duodenal obstruction. Biliary stenting through the mesh of the duodenal SEMS is technically feasible and has a high success rate.

Flexible endoscopic Zenker's diverticulotomy: cap-assisted technique vs. diverticuloscope-assisted technique.

BACKGROUND AND STUDY AIM: The standard treatment for a Zenker's diverticulum is diverticulotomy, either using the endostapling approach or by surgery. Flexible endoscopic diverticulotomy has similar efficacy and is associated with fewer complications but this technique is still under investigation. The aim of this study was to compare the technical results and efficacy of two flexible endoscopic diverticulotomy techniques. PATIENTS AND METHODS: A total of 39 patients with a Zenker's diverticulum were treated using either cap or diverticuloscope assistance to expose the septum, which was then cut with a needle-knife and endocut currents. The severity of symptoms was graded according to their frequencies before the procedure, after 1 month, and to June 2006. RESULTS: Of the 39 patients enrolled into the study, 28 patients were treated with the cap and 11 with the diverticuloscope, the two groups showing no statistical difference in baseline features. The median length of the Zenker's diverticulum was 4 cm (range 2-8 cm). The procedure time was significantly longer with the cap than with diverticuloscope assistance (P = 0.002). Complications occurred in 9/28 patients in the cap group and in none of the patients in the diverticuloscope group (P = 0.04); the perforations that occurred in five patients (18%) were managed endoscopically and conservatively. The median inpatient stay was 3 days (range 2-8 days). The clinical remission rate, evaluated using a pool of symptoms, was significantly higher after the diverticuloscope-assisted procedure compared with the cap technique (82% vs. 29%, P = 0.004). Multivariate analysis showed that the diverticuloscope-assisted technique was the only significant prognostic factor for efficacy (odds ratio 13.09, 95% CI 2.07-82.53). CONCLUSION: The use of the soft diverticuloscope to expose and fix the septum seems to be the optimal approach in terms of increasing the safety and clinical efficacy of flexible endoscopic diverticulotomy.

Prevalence of intestinal metaplasia in the distal esophagus in patients endoscopically suspected for short Barrett's esophagus.

The clinical importance of Barrett's esophagus is related to its correlation to adenocarcinoma. The diagnosis is based on histologic demonstration of specialized intestinal metaplasia in the distal esophagus. The aim of this study was to assess the prevalence of intestinal metaplasia of the distal esophagus in a population submitted to gastroscopy not selected for reflux disease, and with columnar lined distal esophagus between 0.5 and 2 cm. Four biopsies in the distal esophagus were done in 224 patients undergoing routine gastroscopy. Patients were not selected for gastroesophageal reflux. Other clinical parameters were recorded to assess any possible association. In four Centers 224 patients received endoscopy with biopsies demonstrating specialized intestinal metaplasia in 21% of cases. No association was present among the patients with esophagitis or hiatal hernia, as well as with reflux symptoms. A significant association was present in over 70 (females), as well as with the presence of antral intestinal metaplasia demonstrated in 45 patients by gastric biopsies. No other significant associations were present. Biopsy samplings can diagnose the presence of intestinal metaplasia during endoscopy in patients endoscopically suspected for Barrett's esophagus: at present there is not clear evidence to promote this screening to achieve mortality reduction of esophageal adenocarcinoma.

Nonendoscopic transnasal placement of a wireless capsule for esophageal pH monitoring: feasibility, safety, and efficacy of a manometry-guided procedure.

BACKGROUND AND STUDY AIMS: The aim of the study was to evaluate the safety, feasibility, and efficacy of transnasal placement of the Medtronic Bravo capsule for wireless esophageal pH monitoring. PATIENTS AND METHODS: Forty patients with symptomatic gastroesophageal reflux disease were prospectively evaluated. All patients underwent upper gastrointestinal endoscopy and esophageal manometry. The Bravo capsule was then introduced transnasally and released 5 cm above the upper margin of the lower esophageal sphincter. Serial radiographs were performed weekly until capsule release. RESULTS: Of the 40 patients who were evaluated, 38 (95 %) were eligible to undergo the procedure. Transnasal placement proved impossible in one patient (2.5 %). Overall, a total of 39 procedures were performed in 38 patients (the procedure was repeated in one patient because of accidental intragastric fixation). Esophageal placement was successful in 36/39 procedures (92.3 %). The mean duration of the procedure was 10 minutes (range 5 - 16 minutes). Adverse events were noted in five of the 39 procedures (12.8 %), mild epistaxis in two patients (5.1 %) and pharyngeal irritation in three patients (7.7 %). After the procedure, a slight "foreign body" sensation was reported by 20 of the 36 patients (55.5 %) who had undergone successful esophageal placement; two patients (5.5 %) experienced severe retrosternal pain necessitating endoscopic removal of the capsule. At the end of the study, 34 of the 38 patients (89.5 %) stated that they would be willing to undergo the test again if necessary. CONCLUSIONS: Transnasal placement of the Bravo pH capsule is safe, well tolerated, does not require sedation, and avoids endoscopy and its complications.

Capsule endoscopy in patients with chronic abdominal pain.

BACKGROUND: Patients with chronic abdominal pain consult gastroenterologists frequently, requiring a large number of examinations. AIM: To assess the diagnostic yield of capsule endoscopy in patients with chronic abdominal pain of unknown origin and negative diagnostic work-up. PATIENTS: From January 2002 to September 2004, 16 patients (10 female; mean age 42.7 years) who complained of chronic abdominal pain were referred to our unit for capsule endoscopy. METHODS: Chronic abdominal pain was defined as continuous or almost continuous, for at least 3 months and without criteria for other gastrointestinal disorders. All patients had a previous diagnostic work-up including abdominal ultrasonography, oesophagogastroduodenoscopy, colonoscopy and small bowel follow through, performed within 2 months. RESULTS: Capsule endoscopy was normal in 12 patients (75%). Small bowel abnormalities were found in three patients, but were considered irrelevant. In one patient (6.3%), capsule endoscopy revealed ileal erosions and inflammation and was retained in a stricture undetected by radiology. This patient underwent elective surgery which revealed an ileal carcinoid neoplasm. CONCLUSIONS: Capsule endoscopy identified a specific cause of chronic abdominal pain in only one patient. Capsule endoscopy is a safe procedure but does not seem to play an important role in the evaluation of patients with chronic abdominal pain of unknown origin.

Review article: uncomplicated diverticular disease of the colon.

Diverticular disease of the colon is the fifth most important gastrointestinal disease in terms of direct and indirect health care costs in western countries. Uncomplicated diverticular disease is defined as the presence of diverticula in the absence of complications such as perforation, fistula, obstruction and/or bleeding. The distribution of diverticula along the colon varies worldwide being almost always left-sided and directly related to age in western countries and right-sided where diet is rich in fibre. The pathophysiology of diverticular disease is complex and relates to abnormal colonic motility, changes in the colonic wall, chronic mucosal low-grade inflammation, imbalance in colonic microflora and visceral hypersensitivity. Moreover, there can be genetic factors involved in the development of colonic diverticula. The use of non-absorbable antibiotics is the mainstay of therapy in patients with mild to moderate symptoms, and the effect of fibre-supplementation alone does not appear to be significantly different from placebo, although no definite data are available. More recently, alternative treatments have been reported. Mesalazine acts as a local mucosal immunomodulator and has been shown to improve symptoms and prevent recurrence of diverticulitis. In addition, probiotics have also been shown to be beneficial by re-establishing a normal gut microflora. In this study, the current literature on uncomplicated diverticular disease of the colon is reviewed.

Beta-lactamase inhibition with clavulanic acid supplementing standard amoxycillin-based triple therapy does not increase Helicobacter pylori eradication rate.

BACKGROUND: Antibiotic resistance is the main reason of failure for H. pylori eradication and beta-lactamases produced by resistant H. pylori strains is a possible mechanism underlying ineffectiveness of an amoxycillin-based triple therapy. AIM: To investigate the benefit of using clavulanic acid associated with amoxycillin compared with amoxycillin alone in a standard triple therapy. METHODS: A total 172 H. pylori-positive dyspeptic patients were randomised to a daily treatment with esomeprazole (20 mg bid), clarithromycin (500 mg bid) and either amoxycillin plus clavulanic acid (1 g bid) or amoxycillin (1 g bid) alone for 1 week. H. pylori status was defined by histology and urea breath test at entry and following 8 weeks from the end of therapy by urea breath test and antigen faecal assessment. RESULTS: At intention-to-treat and per-protocol analysis eradication rates achieved by amoxycillin plus clavulanic acid (72 and 78%) were higher, but not significantly, than those achieved by amoxycillin alone triple therapy (62 and 72%). Compliance was good, side-effects mild and with a similar incidence in both regimens. CONCLUSIONS: Clavulanic acid supplemented to amoxycillin-based standard triple therapy does not significantly increase the H. pylori eradication rate with standard triple therapy.

One-week once-daily triple therapy with esomeprazole, levofloxacin and azithromycin compared to a standard therapy for Helicobacter pylori eradication.

BACKGROUND: Primary antibiotic-resistance and poor compliance are the main causes of Helicobacter pylori eradication failure of standard regimens. AIM: To investigate eradication rate, patient compliance and tolerability of a 1-week once-daily levofloxacin plus azithromycin triple therapy versus the standard twice-daily triple therapy. PATIENTS AND METHODS: A total of 164 H. pylori-positive patients were randomised to either esomeprazole 20mg, levofloxacin 500 mg and azithromycin 500 mg once-daily (ELAz) or esomeprazole 20mg, clarithromycin 500 mg and amoxycillin 1g twice-daily (ECA) for 1 week. H. pylori infection was defined at entry by histology and urea breath test; cure of infection was determined both by negative urea breath test and H. pylori stool antigens. RESULTS: H. pylori eradication rates of ELAz and ECA were similar at intention-to-treat (both 65%) and per-protocol analyses (70% versus 76%, respectively). Incidence of poor compliance was lower, although not significantly, in patients randomised to ELAz than to ECA (4% versus 10%); tolerability was significantly higher for ELAz than for ECA (88% versus 70%; P=0.01). CONCLUSIONS: Once-daily levofloxacin plus azithromycin-based triple therapy achieves an H. pylori eradication rate comparable to that of standard twice-daily triple therapy, but is associated with higher patient compliance and might even be better tolerated.

Comparison of two different daily dosages (2.4 vs. 1.2 g) of oral mesalazine in maintenance of remission in ulcerative colitis patients: 1-year follow-up study.

BACKGROUND: Mesalazine as maintenance therapy in ulcerative colitis is used worldwide and has been proven to be effective. However, the optimal dosage remains to be defined. AIM: To establish whether daily treatment with 2.4 g of oral mesalazine is more effective than 1.2 g in preventing disease relapse. METHODS: A total of 156 patients with ulcerative colitis in remission were randomly treated for 1 year with 2.4 (n = 80) or 1.2 (n = 76) g/day of mesalazine. Activity of disease was assessed by periodical clinical, endoscopic and histological examinations. RESULTS: After 12 months, 24 of 80 patients (30%) on 2.4 g and 20 of 76 patients (26%) on 1.2 g were still in remission (P = N.S.). Patients in 2.4 g group remained in remission for a longer time than those in 1.2 g group (P < 0.001). Among clinical variables considered in the study, course of disease prior to enrollment (< or = 3 or > 3 relapses/year) was found to influence response to therapy. CONCLUSIONS: A daily dosage of 2.4 g of oral mesalazine seems to better at preventing and delaying relapses of ulcerative colitis than 1.2 g. The course of disease seems to be crucial in choosing the optimal dosage of mesalazine in a maintenance regimen.

Increased thrombin generation and circulating levels of tumour necrosis factor-alpha in patients with chronic Helicobacter pylori-positive gastritis.

BACKGROUND: Conflicting data have been reported concerning the relationship between Helicobacter pylori infection and coronary heart disease. AIM: To evaluate clotting system activation and plasma levels of tumour necrosis factor-alpha, a procoagulant cytokine, in patients with H. pylori-positive and -negative gastritis. METHODS: Three groups of patients were identified: 38 with H. pylori-positive gastritis, 18 with H. pylori-negative gastritis, and 40 H. pylori-negative controls with normal gastric mucosa. Plasma levels of prothrombin fragment 1 + 2 (F1 + 2) and tumour necrosis factor-alpha were assayed. Patients were also controlled after 2 and 6 months following standard H. pylori eradication treatment. RESULTS: At baseline, fragment 1 + 2 and tumour necrosis factor-alpha levels in H. pylori-positive patients were significantly higher than those in H. pylori-negative patients with gastritis (P < 0.05 and P < 0.01, respectively). After H. pylori eradication, fragment 1 + 2 and tumour necrosis factor-alpha levels showed a significant decrease at 2 months (P = 0.03 and P = 0.02, respectively) and a further reduction at 6 months, reaching levels observed in H. pylori-negative patients and controls. CONCLUSIONS: The increase thrombin generation rate and the correlation of plasma fragment 1 + 2 and tumour necrosis factor-alpha levels in H. pylori-positive patients suggest a role for inflammation in mediating the relationship between H. pylori infection and activation of the clotting system.

Diffuse febrile dermatosis in a patient with active ulcerative colitis under treatment with steroids and azathioprine: a case of Sweet's syndrome. Case report and review of literature.

Ulcerative colitis is an inflammatory bowel disease often associated with extra-intestinal manifestations, such as dermatological disorders. Of these, the most frequent are erythema nodosum and pyoderma gangrenosum, the two neutrophilic forms of dermatosis. Another is Sweet' s syndrome, which results in a sudden eruption of tender, raised erythematous or violaceous plaques/papules or nodules, less frequent vesicles, pustules or bullae, involving face, neck, arms and trunk. This skin disorder is frequently observed in patients with leukaemia or connective tissue diseases, while it is very rare in patients with inflammatory bowel disease. The present report deals with the case of a febrile diffuse skin eruption in a 53-year-old patient with moderately active ulcerative colitis after few days' treatment with steroids and azathioprine. At first, the dermatosis was addressed to an idiosyncrasy to azathioprine, which was, therefore, promptly discontinued. Histological examination of skin biopsies revealed the presence of features typical of a Sweet's syndrome. The eruption gradually improved as well as the patient's general condition, until complete regression was achieved following steroid treatment.

Azathioprine or methotrexate in the treatment of patients with steroid-dependent or steroid-resistant ulcerative colitis: results of an open-label study on efficacy and tolerability in inducing and maintaining remission.

BACKGROUND: The role of azathioprine and methotrexate in inducing and maintaining remission in patients with ulcerative colitis is still controversial. AIM: To evaluate the efficacy and tolerability of these two drugs in a series of patients with steroid-dependent or steroid-resistant active ulcerative colitis. METHODS: Forty-two patients were treated with a daily dose of azathioprine (2 mg/kg) and, if intolerant or not responding, with methotrexate (12.5 mg/week intramuscularly), and their efficacy was established by clinical, endoscopic and histological examinations at 6 months. Patients achieving clinical remission continued with treatment and were followed up. RESULTS: Of the 42 patients on azathioprine, 10 experienced early side-effects requiring withdrawal from treatment, 22 (69%) achieved complete remission, six (19%) achieved improvement and four (12%) obtained no substantial benefit. Methotrexate, administered to eight patients intolerant to and two patients resistant to azathioprine, induced complete remission in six patients (60%) and improvement in four (40%). During follow-up, a larger number of patients on azathioprine relapsed in comparison with patients on methotrexate [16/28 (57%) vs. 2/10 (20%), respectively; P < 0.05]. Only minor side-effects were observed on both treatments. CONCLUSIONS: Azathioprine is effective in patients with steroid-dependent or steroid-resistant ulcerative colitis. Methotrexate seems to be a good alternative in patients intolerant to or not responding to azathioprine.

Discrepancy between polymerase chain reaction assay and Western blot analysis in the assessment of CagA status in dyspeptic patients.

BACKGROUND: Infection with CagA-positive Helicobacter pylori may be diagnosed by detecting cagA gene by polymerase chain reaction assay (PCR) or serum antibodies against CagA by Western blot analysis. The aim of this study is to evaluate whether results of PCR and Western blot analysis are in agreement in CagA status assessment. PATIENTS AND METHODS: Thirty-six dyspeptic patients with unknown H. pylori status underwent upper gastrointestinal endoscopy to assess the presence of mucosal lesions and to collect six gastric biopsies (three from the antrum and three from the body) for evaluation of H. pylori infection (rapid urease test, histology and PCR for ureA gene) and gastritis. CagA status was assessed by PCR (cagA gene) on two biopsy specimens and by Western blot analysis of serum (CagA-antibodies) in each patient. RESULTS: At endoscopy, nine patients showed normal mucosa, 15 a duodenal ulcer and 12 antral erosions. Twenty-eight patients were found to be H. pylori-positive and eight H. pylori-negative. Of the 28 H. pylori-positive patients, 17 were CagA-positive and five were CagA-negative by both methods, five were CagA-positive by Western blot analysis but not by PCR and one was CagA-positive by PCR but not by Western blot analysis. Of the eight H. pylori-negative patients, none was CagA-positive by PCR, while six were CagA-positive by Western blot analysis. Therefore, the two tests agreed in only 24 patients (67%). In those patients in whom the PCR and Western blot analysis were not in agreement, the histological features appear to suggest that the results of the Western blot analysis should be considered false positives or false negatives. CONCLUSIONS: PCR and Western blot analysis failed to provide comparable data in many cases. Western blot analysis seems to be more likely to give misleading results than PCR. Thus, PCR seems to be the method of choice to assess CagA status.

Sulphasalazine and 5-aminosalicylic acid in long-term treatment of ulcerative colitis: report on tolerance and side-effects.

BACKGROUND: Use of sulphasalazine in ulcerative colitis patients is hampered by a variety of side-effects, including male infertility. 5-aminosalicylic acid is better tolerated and has been increasingly used to treat patients intolerant/allergic to sulphasalazine but it may also be associated with side-effects. AIM: To evaluate tolerance of long-term treatment with sulphasalazine and 5-aminosalicylic acid in ulcerative colitis. METHODS: Side-effects to sulphasalazine (2-3 g/day) and 5-aminosalicylic acid (1.2-2.4 g/day) were recorded in 685 patients: 410 patients received only sulphasalazine, 130 only 5-aminosalicylic acid, and 145 both drugs. In patients with side-effects to sulphasalazine, a desensitisation protocol (rechallenge) was attempted to improve tolerance, and patients still presenting side-effects after desensitisation were switched to 5-aminosalicylic acid. Male fertility was also assessed in 42 males on sulphasalazine and on 5-aminosalicylic acid. RESULTS: Side-effects were observed in 110/555 patients (20%) on sulphasalazine and in 18/275 patients (6.5%) on 5-aminosalicylic acid during a median period of follow-up of 7 and 5 years, respectively. Desensitisation was achieved in 40% of patients intolerant to sulphasalazine. 5-aminosalicylic acid intake induced side-effects in 2/130 patients (1.5%) who had not taken sulphasalazine before versus 4/91 patients (4%) tolerating sulphasalazine and 12/54 patients (22%) intolerant/allergic to sulphasalazine, the difference in incidence of side-effects in the two latter groups being statistically significant (4.4% vs 20.8%, p=0. 001). Fertility was found to be affected in all patients on sulphasalazine but improved when put onto 5-aminosalicylic acid. CONCLUSIONS: 5-aminosalicylic acid should be considered the drug of choice in the treatment of ulcerative colitis bearing in mind that intolerance or allergy may occur in a few patients also on this drug.