Clinical Trial Summary
Since its introduction more than 40 years ago, endoscopic retrograde cholangiopancreatography
(ERCP) has fundamentally changed the treatment of biliopancreatic diseases. Since late 1970s
there have been sporadic reports of nosocomial infections linked to endoscopic procedures,
the majority caused by inadequate reprocessing of endoscopes. Infections due to
multidrug-resistant organisms (MDROs) however have increasingly become a concern in health
care, including in gastrointestinal (GI) endoscopy. Since 2010, reports of individual cases
and serial outbreaks of MDRO infections associated with ERCP have been published worldwide.
This is because, unlike a gastroscope or colonoscope, the duodenoscope is a complex
instrument with unique mechanical features incorporated at the distal tip. This includes a
recessed space containing an elevator, a wire cable that moves the elevator, working channel,
and most recently, a seal that prevents contamination of the elevator wire channel. This
complex design creates hard-to-reach areas that make optimal mechanical cleaning and
disinfection difficult. With the aim of overcoming these issues, a single-use duodenoscope
(EXALT Model D, Boston Scientific Corporation, Marlborough, Massachusetts, USA) has been
developed in the United States of America (USA) and approved by the United States Food and
Drug Administration (FDA) for clinical use in December 2019. Different studies evaluating
this new device, including randomized clinical trials (RCTs), have already been published,
which have confirmed that single-use duodenoscopes represent an alternative to reusable
duodenoscopes for performing low-complexity ERCP procedures in experienced hands.
Digital Single Operator Cholangioscopy (D-SOC) using the single use Spyglass DS II (Boston
Scientific Corporation, Marlborough, Massachusetts, USA) is a diagnostic and therapeutic
modality which allows for direct endoscopic visualization of the biliopancreatic ductal
system.
The principal diagnostic indication of D-SOC are bile duct or pancreatic strictures and
unclear filling defects, adding direct endoscopic appearance data to biopsy sampling or brush
cytology in order to improve the diagnostic yield.
The major therapeutic indication for D-SOC is lithotripsy for difficult biliary and
pancreatic stones.
However, cholangioscopy increased the risk of post ERCP cholangitis. Bacteremia was suggested
to be specifically related to cholangioscopy in 13.9% of 72 patients, based on serial blood
samplings, and to be associated with biopsy sampling and strictures.
For this reason, the recent European Society of Gastrointestinal Endoscopy (ESGE) guideline
suggests that patients should be considered to be at high risk for post-ERCP cholangitis when
cholangioscopy is performed.
Presently, there are very few clinical reports about technical and clinical outcome of ERCPs
performed with single use duodenoscope and there is complete lack of data about efficacy,
safety and adverse events of the combination of the new single-use duodenoscope and the
Spyglass DS II.
The aim of this multicentric retrospective study was to evaluate the technical success,
clinical outcome and rate of adverse events of this procedure.
