Efficacy of an Endoscopic Device Integrating a Sphincterotome and a Dilation Balloon Catheter for the Treatment of Choledocholithiasis (with Video)
<b>Background/Objectives:</b> The combined techniques of endoscopic sphincterotomy followed by endoscopic papillary balloon dilation (ESBD) and endoscopic sphincterotomy followed by endoscopic papillary large balloon dilation (ESLBD) have gained popularity for the endoscopic treatment of choledocholithiasis. However, the conventional approach to these procedures requires two separate devices, a sphincterotome and a balloon catheter, which can complicate and prolong the procedure. We herein evaluated a novel integrated device combining a sphincterotome and balloon catheter developed to improve the efficiency of ESBD and ESLBD. <b>Methods:</b> This retrospective study compared the clinical outcomes of patients with choledocholithiasis who were treated using conventional sphincterotome and balloon catheters (<i>n</i> = 106) and those who were treated using the integrated device (<i>n</i> = 54). <b>Results:</b> Overall complete stone removal rates (99.1% vs. 100%) and adverse event incidence (12.3% vs. 13.0%) were comparable between the two groups. However, the integrated device significantly reduced total procedure time (40 vs. 27 min, <i>p</i> = 0.01), use of mechanical lithotripter (50.0% vs. 22.2%, <i>p</i> < 0.01), total number of procedures required. <b>Conclusions:</b> Complete stone removal rates and safety were comparable between the two groups. However, the novel integrated device may enhance the efficiency of common bile duct stone removal through ESBD and ESLBD because it eliminates the need to prepare and exchange separate devices.
Authors
- Junichi Hanatani (ORCID: https://orcid.org/0009-0001-9174-2477)
- Hitoshi Yoshiji (ORCID: https://orcid.org/0000-0002-5243-8544)
- Koh Kitagawa (ORCID: https://orcid.org/0000-0001-5794-1512)
- Tadashi Namisaki (ORCID: https://orcid.org/0000-0002-3158-5318)
- Shohei Asada (ORCID: https://orcid.org/0000-0001-5997-4799)
- Yui Osaki (ORCID: https://orcid.org/0009-0009-7147-9278)
- Akira Mitoro (ORCID: https://orcid.org/0000-0002-6666-5633)
- Norihisa Nishimura (ORCID: https://orcid.org/0000-0002-6295-3283)
- Kosuke Kaji (ORCID: https://orcid.org/0000-0002-1822-6759)
- Yukihisa Fujinaga (ORCID: https://orcid.org/0000-0003-2402-574X)
- Yuki Motokawa (ORCID: https://orcid.org/0000-0003-2214-9685)
- Shinya Sato (ORCID: https://orcid.org/0000-0003-3049-3443)
- Tomihiro Iwata (ORCID: https://orcid.org/0009-0007-5644-4435)
Institutions
- Nara Medical University Hospital (JP)
- Nara Medical University (JP)
Publication Details
- Journal
- Journal of Clinical Medicine
- Published
- 2025-08-22
- DOI
- https://doi.org/10.3390/jcm14175930
- Primary Topic
- Gallbladder and Bile Duct Disorders
- Type
- article
- Field-Weighted Citation Impact
- 0.00