A multicenter randomized trial comparing the use of touch versus no-touch guidewire technique for deep biliary cannulation: the TNT study.

BACKGROUND AND AIMS: There are 2 techniques described for selective bile duct guidewire cannulation, the touch (T) technique (engaging the papilla with a sphincterotome and then advancing the guidewire) and the no-touch (NT) technique (engaging the papilla only with the guidewire). The aim of this prospective, multicenter randomized study was to compare the outcomes of the 2 guidewire cannulation techniques. METHODS: Three hundred consecutive patients with naïve papillae were enrolled in 2 groups (150 to T group and 150 to NT group). A maximum of 15 biliary cannulation attempts, for no longer than 5 minutes, or a maximum of 5 unintentional cannulations of the pancreatic duct for each group were performed. If biliary cannulation failed, the patient was crossed over to the other technique with the same parameters. The primary outcome was the guidewire cannulation success rate using either the T or NT technique. Secondary outcomes were the number of attempts and cannulation duration, number of pancreatic duct cannulations, and adverse events. RESULTS: The primary cannulation rate was significantly higher in the T group compared with the NT group (88% vs 54%, P < .001), and the cannulation rate was significantly higher using the T technique compared with the NT technique also after crossover (77% vs 17%, P < .001). The mean number of cannulation attempts was 4.6 in the T group versus 5.5 in the NT group (P = .006), and the duration of cannulation before crossover (P < .001) and overall cannulation duration after crossover (P < .001) were significantly lower in the T group. The number of unintended pancreatic duct cannulations was statistically higher using the T technique compared with the NT technique (P = .037). The rates of adverse events did not significantly differ between the 2 groups. CONCLUSIONS: Our results clearly indicated that the T technique is superior to the NT technique for biliary cannulation. (Clinical trial registration number: NCT01954602.).

Efficacy of adalimumab as second-line therapy in a pediatric cohort of Crohn's disease patients who failed infliximab therapy: the Italian Society of Pediatric Gastroenterology, Hepatology, and Nutrition experience.

BACKGROUND: Adalimumab (Ada) treatment is an available option for pediatric Crohn's disease (CD) and the published experience as rescue therapy is limited. OBJECTIVES: We investigated Ada efficacy in a retrospective, pediatric CD cohort who had failed previous infliximab treatment, with a minimum follow-up of 6 months. METHODS: In this multicenter study, data on demographics, clinical activity, growth, laboratory values (CRP) and adverse events were collected from CD patients during follow-up. Clinical remission (CR) and response were defined with Pediatric CD Activity Index (PCDAI) score ≤10 and a decrease in PCDAI score of ≥12.5 from baseline, respectively. RESULTS: A total of 44 patients were consecutively recruited (mean age 14.8 years): 34 of 44 (77%) had active disease (mean PCDAI score 24.5) at the time of Ada administration, with a mean disease duration of 3.4 (range 0.3-11.2) years. At 6, 12, and 18 months, out of the total of the enrolled population, CR rates were 55%, 78%, and 52%, respectively, with a significant decrease in PCDAI scores (P<0.01) and mean CRP values (mean CRP 5.7 and 2.4 mL/dL, respectively; P<0.01) at the end of follow-up. Steroid-free remission rates, considered as the total number of patients in CR who were not using steroids at the end of this study, were 93%, 95%, and 96% in 44 patients at 6, 12, and 18 months, respectively. No significant differences in growth parameters were detected. In univariate analysis of variables related to Ada efficacy, we found that only a disease duration >2 years was negatively correlated with final PCDAI score (P<0.01). Two serious adverse events were recorded: 1 meningitis and 1 medulloblastoma. CONCLUSION: Our data confirm Ada efficacy in pediatric patients as second-line biological therapy after infliximab failure. Longer-term prospective data are warranted to define general effectiveness and safety in pediatric CD patients.

Primary and Secondary Stability of Implants in Postextraction and Healed Sites: A Randomized Controlled Clinical Trial.

PURPOSE: This randomized clinical trial aimed to investigate the relationships between insertion torque, implant stability quotient (ISQ), and crestal bone loss (CBL) of implants placed in fresh or 12-week healed extraction sites. MATERIALS AND METHODS: Forty patients were randomly assigned to one of two groups and had one implant placed immediately (test group, n = 20) or 12 weeks after extraction (control group, n = 20) at premolar or molar sites. For all implants, insertion torque and ISQ scores at insertion and loading were recorded. Patients were followed for up to 12 months. RESULTS: Implant success was 100% in both groups. No differences were observed concerning both ISQ at insertion and ISQ at loading. A stronger correlation was detected between ISQ at insertion and insertion torque in the postextractive group (R = 0.83), than in the delayed group (R = 0.39), while ISQ at loading and insertion torque showed no correlation. CBL at 12 months was significantly different between test (0.68 ± 0.43 mm) and control (0.40 ± 0.26 mm, P = .02) groups. CONCLUSION: Implant placement timing (immediate or delayed) may affect correlation between insertion torque and ISQ at insertion with ISQ at loading. While insertion torque influences ISQ at insertion, it does not affect ISQ at loading because of successful osseointegration. Postextraction and delayed implants seem to have similar ISQ at insertion and at loading, but different CBL after 12 months of follow-up because of postextraction bone remodeling.