Gradual stiffness versus magnetic imaging-guided variable stiffness colonoscopes: A randomized noninferiority trial.

BACKGROUND: Colonoscopes with gradual stiffness have recently been developed to enhance cecal intubation. OBJECTIVE: We aimed to determine if the performance of gradual stiffness colonoscopes is noninferior to that of magnetic endoscopic imaging (MEI)-guided variable stiffness colonoscopes. METHODS: Consecutive patients were randomized to screening colonoscopy with Fujifilm gradual stiffness or Olympus MEI-guided variable stiffness colonoscopes. The primary endpoint was cecal intubation rate (noninferiority limit 5%). Secondary endpoints included cecal intubation time. We estimated absolute risk differences with 95% confidence intervals (CIs). RESULTS: We enrolled 475 patients: 222 randomized to the gradual stiffness instrument, and 253 to the MEI-guided variable stiffness instrument. Cecal intubation rate was 91.7% in the gradual stiffness group versus 95.6% in the variable stiffness group. The adjusted absolute risk for cecal intubation failure was 4.3% higher in the gradual stiffness group than in the variable stiffness group (upper CI border 8.1%). Median cecal intubation time was 13 minutes in the gradual stiffness group and 10 minutes in the variable stiffness group (p < 0.001). CONCLUSIONS: The study is inconclusive with regard to noninferiority because the 95% CI for the difference in cecal intubation rate between the groups crosses the noninferiority margin. (ClinicalTrials.gov identifier: NCT01895504).

Magnetic endoscopic imaging versus standard colonoscopy in a routine colonoscopy setting: a randomized, controlled trial.

BACKGROUND: Knowing the position of the endoscope within the abdomen is important for performing a high-quality, painless colonoscopy. The recently introduced magnetic endoscopic imaging (MEI) system provides a continuous, real-time image of the endoscope during the entire procedure. OBJECTIVE: To compare MEI versus standard colonoscopy with on-demand fluoroscopy on unsedated patients, as performed by experienced and inexperienced endoscopists. DESIGN: Randomized, controlled trial. SETTING: Endoscopy outpatient clinic. PATIENTS: This study involved 810 consecutive patients (391 randomized to standard group; 419 randomized to MEI) referred for colonoscopy. INTERVENTION: MEI or standard approach (involving on-demand fluoroscopy) during colonoscopy. MAIN OUTCOME MEASUREMENTS: Perceived patient pain and cecal intubation rate and time to cecum. RESULTS: For inexperienced endoscopists, the cecal intubation rate was significantly higher in the MEI group (77.8%) compared with the standard group (56.0%), P = .02 but not for experienced endoscopists (94.0% for MEI and 96.0% for standard group, P = .87). Inexperienced endoscopists had less need for assistance from a senior colleague when they used MEI (18.5%) compared with the standard technique (40.0%), P = .02. Mean (± standard deviation) time to reach the cecum was 14.0 ± 12.2 minutes in the MEI group and 15.3 ± 14.2 minutes in the standard group, P = .67. LIMITATIONS: Single center, unblinded study. CONCLUSION: Inexperienced endoscopists improved their colonoscopy performance when they used MEI, compared with the standard technique, but experienced endoscopists did not. The MEI may be advantageous to use for colonoscopy centers educating endoscopists. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT00519129.).

Results of faecal donor instillation therapy for recurrent Clostridium difficile-associated diarrhoea.

We report a success rate of 83% with faecal donor instillation therapy (FDIT) in this retrospective study of 40 patients with recurrent Clostridium difficile-associated diarrhoea (CDAD), treated at a medium sized Norwegian hospital from 1994 through 2008. The stool transplant was instilled either in the duodenum through a gastroscope or in the colon through a colonoscope with next of kin or other household member as donor. In 29 cases (73%) the first treatment was successful, with no documented recurrence of diarrhoeal disease within 80 days. Of the 11 patients failing to respond to the first instillation treatment, 6 patients received a second instillation, 4 of which were successful. A total of 33 patients (83%) were successfully treated with FDIT. Of the 7 non-responders, 5 were seriously ill due to long lasting diarrhoeal disease and co-morbidity and died within 80 days after the procedure, and 2 were believed to have inflammatory bowel disease with response to corticosteroid treatment. No adverse effects of FDIT were observed. In our experience the procedure is easy to perform, well tolerated, effective, and may be a valuable treatment option in selected cases.

Effect of oral lansoprazole on intragastric pH after endoscopic treatment for bleeding peptic ulcer.

OBJECTIVE: Intravenous proton pump inhibitors (PPIs) induce a high intragastric pH and may thereby improve haemostasis in patients with bleeding peptic ulcer. The aim of this study was to investigate whether a similar therapeutic intragastric pH level could be reached when the PPI was administered orally. MATERIAL AND METHODS: Twenty-four-hour intragastric pH was measured in patients treated endoscopically for bleeding peptic ulcer (Forrest class I or II). The patients received lansoprazole capsules (90 mg) after successful endoscopic treatment, followed by 30 mg every third hour for 72 h. The primary end-point was the percentage of the 0 to 24-h registration period with an intragastric pH of 6 or higher. Additionally, the total number of patients obtaining an intragastric pH above 6 for 80% or more of the 0 to 24-h period after start of treatment was evaluated. RESULTS: Of the 14 patients included in the study (4 F, mean age 74 years, range 50-84 years), 10 patients had duodenal ulcer and 4 had gastric ulcer; median lowest Hgb: 8.9 mg/ml (range 5.8-12.4), blood transfusions: 2.7 SAG units (range 0-7). In the 0 to 24-h period, the median time duration of pH above 6 was 55% (range 6-99). One out of 14 patients (7%) reached a pH above 6 in at least 80% of this time period. CONCLUSIONS: An increase in intragastric pH of therapeutic importance was reached with this oral medication regimen. However, there were large intra-individual differences. Treatment with oral lansoprazole may be a therapeutic alternative to intravenous administration of PPI.

High-dose ursodeoxycholic acid in primary sclerosing cholangitis: a 5-year multicenter, randomized, controlled study.

BACKGROUND & AIMS: There is no medical treatment of proven benefit for primary sclerosing cholangitis. This study aimed at studying the effect of a higher dose of ursodeoxycholic acid than previously used on survival, symptoms, biochemistry, and quality of life in this disease. METHODS: A randomized placebo-controlled study was performed in tertiary and secondary gastroenterology units. A total of 219 patients were randomized to 17 to 23 mg/kg body weight per day of ursodeoxycholic acid (n = 110) or placebo (n = 109) for 5 years. Follow-up data are available from 97 patients randomized to ursodeoxycholic acid and for 101 randomized to placebo. Quality of life was assessed by using the Medical Outcomes Study 36-item Short-Form Health Survey. RESULTS: The combined end point "death or liver transplantation" occurred in 7 of 97 (7.2%) patients in the ursodeoxycholic acid group vs 11 of 101 (10.9%) patients in the placebo group (P = .368; 95% confidence interval, -12.2% to 4.7%). The occurrence of liver transplantation as a single end point showed a similar positive trend for ursodeoxycholic acid treatment (5/97 [5.2%] vs 8/101 [7.9%]; 95% confidence interval, -10.4% to 4.6%). Three ursodeoxycholic acid and 4 placebo patients died from cholangiocarcinoma, and 1 placebo patient died from liver failure. Alkaline phosphatase and alanine aminotransferase tended to decrease during the first 6 months. There were no differences between the 2 groups in symptoms or quality of life. Analyses of serum ursodeoxycholic acid concentration gave no evidence that noncompliance may have influenced the results. CONCLUSIONS: This study found no statistically significant beneficial effect of a higher dose of ursodeoxycholic acid than previously used on survival or prevention of cholangiocarcinoma in primary sclerosing cholangitis.