Clinical Trial
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Diagnosis of pancreatic cysts: EUS-guided, through-the-needle confocal laser-induced endomicroscopy and cystoscopy trial: DETECT study.

BACKGROUND: The diagnosis of pancreatic cystic neoplasms (PCNs), which now depends on morphology, cytology, and fluid analysis, is still challenging. A novel confocal laser endomicroscopy probe that can be inserted through a 19-gauge FNA needle allows needle-based confocal laser endomicroscopy (nCLE), and the feasibility of nCLE has been reported in PCNs. The combination of cystoscopy by using a through-the-needle fiberoptic probe in combination with nCLE under EUS guidance may improve the diagnosis of PCNs.

OBJECTIVE: To assess the feasibility, safety, and diagnostic yield of the combination of cystoscopy and nCLE in the clinical diagnosis of PCNs.

DESIGN: A prospective feasibility study.

SETTING: An academic tertiary referral center.

PATIENTS: Thirty patients with PCNs.

INTERVENTIONS: EUS-guided dual through-the-needle imaging (cystoscopy and nCLE) for PCNs.

MAIN OUTCOME MEASUREMENTS: Technical feasibility and safety. Associations of cystoscopy and nCLE findings with clinical diagnosis of PCNs.

RESULTS: The procedure was technically successful with the exception of 1 probe exchange failure. In 2 patients (7%), postprocedure pancreatitis developed. Specific features associated with the clinical diagnosis of mucinous cysts were identified: mucin on cystoscopy and papillary projections and dark rings on nCLE. The sensitivity of cystoscopy was 90% (9/10), and that of nCLE was 80% (8/10), and the combination was 100% (10/10) in 18 high-certainty patients.

LIMITATIONS: A single-center study and lack of complete pathologic correlation.

CONCLUSION: The combination of dual through-the-needle imaging (cystoscopy and nCLE) of pancreatic cysts appears to have strong concordance with the clinical diagnosis of PCN. (

CLINICAL TRIAL REGISTRATION NUMBER: NCT01447238.).

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