RSS-Feed abonnieren
DOI: 10.1055/a-0835-5900
Comparison between a rotatable sphincterotome and a conventional sphincterotome for selective bile duct cannulation
TRIAL REGISTRATION: Single-center, randomized, prospective study UMIN000018032 at http://www.umin.ac.jpPublikationsverlauf
submitted 16. März 2018
accepted after revision 22. Dezember 2018
Publikationsdatum:
13. Februar 2019 (online)
Abstract
Background Selective biliary cannulation (SBC) is the first challenge of endoscopic retrograde cholangiopancreatography (ERCP), especially for trainees, and a rotatable sphincterotome may be useful to guide the directional axis of the scope and SBC.
Methods We performed a prospective randomized single-center trial, enrolling 200 patients with a native papilla who required therapeutic biliary ERCP. Patients were randomly assigned to the rotatable sphincterotome group (n = 100) or the conventional sphincterotome group (n = 100). The primary endpoint was successful SBC by the trainees within 10 minutes.
Results The early and late cannulation success rates did not differ significantly between the groups (P = 0.46 and P > 0.99, respectively). For the patients in whom trainees failed to achieve SBC, the rotatable sphincterotome was used as a rescue cannulation technique in four patients from the conventional group; in no patients in the rotatable group was the conventional sphincterotome used for SBC. Post-ERCP pancreatitis (PEP) occurred in 11 patients (5.5 %; 6 mild, 5 moderate); the incidence did not differ significantly between the two groups (rotatable group 3 %, conventional group 8 %; P = 0.21). The two groups were thus combined for evaluation of the factors relating to cannulation difficulty for trainees, which revealed that orientation of the papilla was a significant factor (P < 0.001).
Conclusions The type of sphincterotome used did not affect the success of SBC by trainees. However, orientation of the papilla was revealed to be a significant factor relating to cannulation difficulty for trainees overall.
-
References
- 1 Cotton PB. Endoscopic Retrograde Cholangiopancreatography: Maximizing Benefits and Minimizing Risks. Gastrointest Endosc Clin N Am 2012; 22: 587-599
- 2 Andriulli A, Loperfido S, Napolitano G. et al. Incidence rates of post-ERCP complications: A systematic survey of prospective studies. Am J Gastroenterol 2007; 102: 1781-1788
- 3 Anderson MA, Fisher L. ASGE Standards of Practice Committee. et al. Complications of ERCP. Gastrointest Endosc 2012; 75: 467-473
- 4 Chandrasekhara V, Khashab MA, Muthusamy VR. et al. Adverse events associated with ERCP. Gastrointest Endosc 2017; 85: 32-47
- 5 Lim BS, Leung JW, Lee J. et al. Effect of ERCP mechanical simulator (EMS) practice on trainees ERCP performance in the early learning period: US multicenter randomized controlled trial. Am J Gastroenterol 2011; 106: 300-306
- 6 Liao WC, Leung J, Wang HP. et al. Coached practice using ERCP mechanical simulator improves trainees’ ERCP performance: A randomized controlled trial. Endoscopy 2013; 45: 799-805
- 7 Kim GH, Kang DH, Song GA. et al. Endoscopic removal of bile-duct stones by using a rotatable papillotome and a large-balloon dilator in patients with a Billroth II gastrectomy (with video). Gastrointest Endosc 2008; 67: 1134-1138
- 8 Maluf-Filho F, Kumar A, De Souza TF. et al. Rotatable sphincterotome facilitates bile duct cannulation in patients with altered ampullary anatomy. Gastroenterol Hepatol 2008; 4: 59-62
- 9 Jorgensen J, Kubiliun N, Law JK. et al. Endoscopic retrograde cholangiopancreatography (ERCP): Core curriculum. Gastrointest Endosc 2016; 83: 279-289
- 10 Testoni PA, Mariani A, Aabakken L. et al. Papillary cannulation and sphincterotomy techniques at ERCP: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy 2016; 48: 657-683
- 11 Pan Y, Zhao L, Leung J. et al. Appropriate time for selective biliary cannulation by trainees during ERCP - A randomized trial. Endoscopy 2015; 47: 688-695
- 12 Cotton PB, Eisen GM, Aabakken L. et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 2010; 71: 446-454
- 13 Baillie J, Testoni PA. Erratum: Are we meeting the standards set for ERCP?. Gut 2007; 56: 744-746
- 14 Adler DG, Lieb JG, Cohen J. et al. Quality indicators for ERCP. Gastrointest Endosc 2015; 81: 54-66