Effect of Disposable Elevator Cap Duodenoscopes on Persistent Microbial Contamination and Technical Performance of Endoscopic Retrograde Cholangiopancreatography: The ICECAP Randomized Clinical Trial.

Importance: Infection transmission following endoscopic retrograde cholangiopancreatography (ERCP) can occur due to persistent contamination of duodenoscopes despite high-level disinfection to completely eliminate microorganisms on the instrument. Objective: To determine (1) contamination rates after high-level disinfection and (2) technical performance of duodenoscopes with disposable elevator caps compared with those with standard designs. Design, Setting, and Participants: In this parallel-arm multicenter randomized clinical trial at 2 tertiary ERCP centers in Canada, all patients 18 years and older and undergoing ERCP for any indication were eligible. Intervention: The intervention was use of duodenoscopes with disposable elevator caps compared with duodenoscopes with a standard design. Main Outcomes and Measures: Coprimary outcomes were persistent microbial contamination of the duodenoscope elevator or channel, defined as growth of at least 10 colony-forming units of any organism or any growth of gram-negative bacteria following high-level disinfection (superiority outcome), and technical success of ERCP according to a priori criteria (noninferiority outcome with an a priori noninferiority margin of 7%), assessed by blinded reviewers. Results: From December 2019 to February 2022, 518 patients were enrolled (259 disposable elevator cap duodenoscopes, 259 standard duodenoscopes). Patients had a mean (SD) age of 60.7 (17.0) years and 258 (49.8%) were female. No significant differences were observed between study groups, including in ERCP difficulty. Persistent microbial contamination was detected in 11.2% (24 of 214) of standard duodenoscopes and 3.8% (8 of 208) of disposable elevator cap duodenoscopes (P = .004), corresponding to a relative risk of 0.34 (95% CI, 0.16-0.75) and number needed to treat of 13.6 (95% CI, 8.1-42.7) to avoid persistent contamination. Technical success using the disposable cap scope was noninferior to that of the standard scope (94.6% vs 90.7%, P = .13). There were no differences between study groups in adverse events and other secondary outcomes. Conclusions and Relevance: In this randomized clinical trial, disposable elevator cap duodenoscopes exhibited reduced contamination following high-level disinfection compared with standard scope designs, without affecting the technical performance and safety of ERCP. Trial Registration: ClinicalTrials.gov Identifier: NCT04040504.

Diagnostic yield of small histological cores obtained with a new EUS-guided fine needle biopsy system.

BACKGROUND: As endoscopic ultrasound-guided tissue acquisition techniques evolve, there is increasing interest in obtaining optimal histological samples to improve diagnostic accuracy. In this study, we aimed to assess the tissue acquisition success rate and test performance characteristics of a novel endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) system. METHODS: We performed a retrospective review of consecutive patients undergoing EUS-guided tissue sampling of solid lesions using the SharkCore fine needle system in a tertiary referral facility. At least two passes were submitted for histology and diagnostic accuracy was evaluated. Comparison standard was based on final surgical pathology or minimum six-month clinical follow-up. RESULTS: Seventy-nine patients underwent 85 EUS-FNB procedures. Of the 85 histology specimens, 78 (91.7%) were adequate for diagnostic examination (includes six atypical/suspicious for adenocarcinoma). The sensitivity, specificity, and accuracy for diagnosis of malignancy with FNB were 87.1, 100, and 90.6%, respectively. Cytology was simultaneously sent in 43 cases with the same needle in addition to histology. Out of the 14 cases that were atypical/suspicious for adenocarcinoma or non-diagnostic on cytology, 11 cases (78.6%) achieved definite diagnoses on histology. The overall sensitivity, specificity, and accuracy for diagnosis of malignancy combining histology and cytology were 90.3, 100, and 92.9%, respectively. No complications were reported after the procedures. CONCLUSION: In this initial experience with a new EUS-guided FNB system, obtaining small cores to submit for histological analysis was safe, technically feasible, and highly accurate. Most of the histological cores obtained via FNB yielded a definite diagnosis including in cases with equivocal cytomorphology. Further study is required to confirm these findings.

Prevalence of vitamin D deficiency and response to oral vitamin D supplementation in patients receiving home parenteral nutrition.

UNLABELLED: The purpose of this study was to document vitamin D status in home parenteral nutrition (HPN) patients and determine if oral vitamin D supplementation has a substantial effect. METHODS: A retrospective chart review of eligible adults enrolled in the Southern Alberta Home Parenteral Nutrition program (n = 15) for a minimum of 6 months was conducted. Serum measurements of 25OHD were recorded and patients were categorized by vitamin D status as follows: sufficient; insufficient; deficient with respective levels of 25OHD ≥75 nmol/L, 27.5-75 nmol/L, and ≤27.5 nmol/L; and mixed. RESULTS: Five of 15 patients had insufficient vitamin D status throughout the study period; all had short bowel syndrome. Nine were in the mixed category; 1 was consistently sufficient, and no one was consistently deficient. Patient demographics were similar between the insufficient and mixed groups. There were no significant differences in health outcomes between the insufficient and mixed vitamin D status groups. The median (interquartile range) dose and duration of vitamin D3 supplementation for the insufficient group was 5000 IU/d (4,000-7,143) for 1,175 (1,145-1,578) total days compared to 3,000 IU/d (1,000-7,143) for 1,529 (111-1,980) days for the mixed group. CONCLUSIONS: Most patients receiving HPN had insufficient vitamin D status. When prescribed high doses of oral vitamin D, patients did not consistently achieve appropriate 25OHD levels. Alternate routes of vitamin D supplementation in patients receiving HPN should be considered. Large multicenter prospective studies are needed to best characterize the relationship between vitamin D dosing for HPN patients and vitamin D status.