Prospective randomized trial of a new multibending versus conventional ultra-slim endoscope for peroral cholangioscopy without device or endoscope assistance (with video)

Published:August 20, 2019DOI:https://doi.org/10.1016/j.gie.2019.08.007

      Background and Aims

      Currently available peroral cholangioscopy (POC) is a duodenoscopy-assisted procedure that does not involve directly inserting an endoscope into the biliary tree. A prototype multibending (MB) ultra-slim endoscope has been developed as a dedicated cholangioscope to overcome the technical difficulties of direct POC. In this study, we evaluated the efficacy of the new MB ultra-slim endoscope compared with a conventional ultra-slim endoscope for free-hand insertion of an endoscope into the bile duct for direct POC without the assistance of accessories.

      Methods

      Ninety-two patients with biliary disease requiring diagnostic and/or therapeutic direct POC were assigned randomly to groups examined using an MB ultra-slim endoscope (MB group, n=46) versus a conventional ultra-slim endoscope (conventional group, n=46). The primary outcome was the technical success of free-hand insertion of the endoscope during direct POC, defined as successful insertion of the endoscope through the ampulla of Vater and advancement of the endoscope up to the bifurcation or to the obstructed segment of the biliary tree without any accessories within 15 minutes.

      Results

      Free-hand biliary insertion of the endoscope for direct POC was technically successful in 41 patients (89.1%) in the MB group, which was significantly higher than the rate (14 patients, 30.4%) in the conventional group (P < .001). The procedure time (mean ± standard deviation) of direct POC using free-hand biliary insertion of the endoscope was significantly shorter in the MB group than in the conventional group (3.2 ± 1.8 vs 6.0 ± 3.0 minutes, P = .004). Adverse events were observed in 3 patients (6.5%) in the MB group and 2 patients (4.3%) in the conventional group (P = .500), all of whom were treated conservatively. The technical success rates of the diagnostic or therapeutic intervention were not significantly different between the 2 groups in patients undergoing successful direct POC.

      Conclusions

      Free-hand biliary insertion of the MB ultra-slim endoscope showed a high technical success rate without severe adverse events and effectively decreased procedure time compared with a conventional ultra-slim endoscope. Direct POC using the MB ultra-slim endoscope can be used for novel diagnostic and therapeutic procedures of the biliary tree without the assistance of another endoscope or accessory. (Clinical trial registration number: NCT02189421.)

      Graphical abstract

      Abbreviations:

      AOV (ampulla of Vater), CBD (common bile duct), MB (multibending), POC (peroral cholangioscopy)
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      References

        • Moon J.H.
        • Terheggen G.
        • Choi H.J.
        • et al.
        Peroral cholangioscopy: diagnostic and therapeutic applications.
        Gastroenterology. 2013; 144: 276-282
        • Committee A.T.
        • Komanduri S.
        • Thosani N.
        • et al.
        Cholangiopancreatoscopy.
        Gastrointest Endosc. 2016; 84: 209-221
        • Lee Y.N.
        • Moon J.H.
        • Choi H.J.
        • et al.
        Direct peroral cholangioscopy for diagnosis of bile duct lesions using an I-SCAN ultraslim endoscope: a pilot study.
        Endoscopy. 2017; 49: 675-681
        • Moon J.H.
        • Ko B.M.
        • Choi H.J.
        • et al.
        Intraductal balloon-guided direct peroral cholangioscopy with an ultraslim upper endoscope (with videos).
        Gastrointest Endosc. 2009; 70: 297-302
        • Ishida Y.
        • Itoi T.
        • Okabe Y.
        Types of peroral cholangioscopy: how to choose the most suitable type of cholangioscopy.
        Curr Treat Options Gastroenterol. 2016; 14: 210-219
        • Choi H.J.
        • Moon J.H.
        • Ko B.M.
        • et al.
        Overtube-balloon-assisted direct peroral cholangioscopy by using an ultra-slim upper endoscope (with videos).
        Gastrointest Endosc. 2009; 69: 935-940
        • Cotton P.B.
        • Eisen G.M.
        • Aabakken L.
        • et al.
        A lexicon for endoscopic adverse events: report of an ASGE workshop.
        Gastrointest Endosc. 2010; 71: 446-454
        • Navaneethan U.
        • Hasan M.K.
        • Kommaraju K.
        • et al.
        Digital, single-operator cholangiopancreatoscopy in the diagnosis and management of pancreatobiliary disorders: a multicenter clinical experience (with video).
        Gastrointest Endosc. 2016; 84: 649-655
        • Lee Y.N.
        • Moon J.H.
        • Choi H.J.
        • et al.
        A newly modified access balloon catheter for direct peroral cholangioscopy by using an ultraslim upper endoscope (with videos).
        Gastrointest Endosc. 2016; 83: 240-247
        • Sun X.
        • Zhou Z.
        • Tian J.
        • et al.
        Is single-operator peroral cholangioscopy a useful tool for the diagnosis of indeterminate biliary lesion? A systematic review and meta-analysis.
        Gastrointest Endosc. 2015; 82: 79-87
        • Mounzer R.
        • Austin G.L.
        • Wani S.
        • et al.
        Per-oral video cholangiopancreatoscopy with narrow-band imaging for the evaluation of indeterminate pancreaticobiliary disease.
        Gastrointest Endosc. 2017; 85: 509-517
        • Tringali A.
        • Lemmers A.
        • Meves V.
        • et al.
        Intraductal biliopancreatic imaging: European Society of Gastrointestinal Endoscopy (ESGE) technology review.
        Endoscopy. 2015; 47: 739-753
        • Buxbaum J.
        • Sahakian A.
        • Ko C.
        • et al.
        Randomized trial of cholangioscopy-guided laser lithotripsy versus conventional therapy for large bile duct stones (with videos).
        Gastrointest Endosc. 2018; 87: 1050-1060
        • Lee Y.N.
        • Moon J.H.
        • Choi H.J.
        • et al.
        Direct peroral cholangioscopy using an ultraslim upper endoscope for management of residual stones after mechanical lithotripsy for retained common bile duct stones.
        Endoscopy. 2012; 44: 819-824
        • Pohl J.
        • Ell C.
        Direct transnasal cholangioscopy with ultraslim endoscopes: a one-step intraductal balloon-guided approach.
        Gastrointest Endosc. 2011; 74: 309-316
        • Meves V.
        • Ell C.
        • Pohl J.
        Efficacy and safety of direct transnasal cholangioscopy with standard ultraslim endoscopes: results of a large cohort study.
        Gastrointest Endosc. 2014; 79: 88-94
        • Pohl J.
        • Meves V.C.
        • Mayer G.
        • et al.
        Prospective randomized comparison of short-access mother-baby cholangioscopy versus direct cholangioscopy with ultraslim gastroscopes.
        Gastrointest Endosc. 2013; 78: 609-616
        • Itoi T.
        • Nageshwar Reddy D.
        • Sofuni A.
        • et al.
        Clinical evaluation of a prototype multi-bending peroral direct cholangioscope.
        Dig Endosc. 2014; 26: 100-107
        • Beyna T.
        • Farnik H.
        • Sarrazin C.
        • et al.
        Direct retrograde cholangioscopy with a new prototype double-bending cholangioscope.
        Endoscopy. 2016; 48: 929-933
        • Choi H.J.
        • Moon J.H.
        • Ko B.M.
        • et al.
        Clinical feasibility of direct peroral cholangioscopy-guided photodynamic therapy for inoperable cholangiocarcinoma performed by using an ultra-slim upper endoscope (with videos).
        Gastrointest Endosc. 2011; 73: 808-813
        • Ghersi S.
        • Fuccio L.
        • Bassi M.
        • et al.
        Current status of peroral cholangioscopy in biliary tract diseases.
        World J Gastrointest Endosc. 2015; 7: 510-517
        • Efthymiou M.
        • Raftopoulos S.
        • Antonio Chirinos J.
        • et al.
        Air embolism complicated by left hemiparesis after direct cholangioscopy with an intraductal balloon anchoring system.
        Gastrointest Endosc. 2012; 75: 221-223
        • Kondo H.
        • Naitoh I.
        • Nakazawa T.
        • et al.
        Development of fatal systemic gas embolism during direct peroral cholangioscopy under carbon dioxide insufflation.
        Endoscopy. 2016; 48: E215-E216

      Linked Article

      • A new era in direct peroral cholangioscopy: bending over backward to overcome limitations of the past
        Gastrointestinal EndoscopyVol. 91Issue 1
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          Cholangioscopy is increasingly used as an adjunct procedure for the diagnosis and treatment of bile duct disorders, including benign and malignant strictures and choledocholithiasis.1-3 Cholangioscopy can be performed with mother-baby cholangioscope systems or with direct peroral cholangioscopes (DPCs). Early iterations of mother-baby cholangioscopes were cumbersome, were technically challenging, required 2 operators, and have now largely been supplanted by disposable digital single-operator cholangioscopes (DSOCs) (SpyGlass Direct Visualization System, Boston Scientific, Marlborough, Mass, USA).
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