Study Summary
This trial is comparing two different ways to remove large bile duct stones. One method uses a laser or EHL to break up the stones, while the other method uses dilation to remove the stones.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: 2 hours
1 week
Adverse Events
2 hours
First procedure stone clearance
Procedure Time
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Papillary Balloon dilation
1 of 2
Intraductal lithotripsy
1 of 2
Active Control
90 Total Participants · 2 Treatment Groups
Primary Treatment: Papillary Balloon dilation · No Placebo Group · N/A
Papillary Balloon dilation
Procedure
ActiveComparator Group · 1 Intervention: Initial therapy with papillary balloon dilation · Intervention Types: ProcedureIntraductal lithotripsy
Procedure
ActiveComparator Group · 1 Intervention: Initial therapy with intraductal lithotripsy · Intervention Types: ProcedureTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 hours
Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
827 Previous Clinical Trials
1,419,925 Total Patients Enrolled
James Buxbaum, MDPrincipal InvestigatorUniversity of Southern California
6 Previous Clinical Trials
1,020 Total Patients Enrolled
Ara Sahakian, MDPrincipal InvestigatorUniversity of Southern California
Eligibility Criteria
Age 18 - 115 · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Lee, John G.. 2009. “Diagnosis and Management of Acute Cholangitis”. Nature Reviews Gastroenterology & Hepatology. Springer Science and Business Media LLC. doi:10.1038/nrgastro.2009.126.
- Kiriyama, Seiki, Tadahiro Takada, Steven M. Strasberg, Joseph S. Solomkin, Toshihiko Mayumi, Henry A. Pitt, Dirk J. Gouma, et al.. 2013. “TG13 Guidelines for Diagnosis and Severity Grading of Acute Cholangitis (with Videos)”. Journal of Hepato-biliary-pancreatic Sciences. Wiley. doi:10.1007/s00534-012-0561-3.
- Chang, Wen-Hsiung. 2004. “Outcome of Simple Use of Mechanical Lithotripsy of Difficult Common Bile Duct Stones”. World Journal of Gastroenterology. Baishideng Publishing Group Inc.. doi:10.3748/wjg.v11.i4.593.
- Kim, Hoon Il, Jong Ho Moon, Hyun Jong Choi, Jong Chan Lee, Hyung Su Ahn, A. Ri Song, Tae Hoon Lee, Young Deok Cho, Sang-Heum Park, and Sun-Joo Kim. 2011. “Holmium Laser Lithotripsy Under Direct Peroral Cholangioscopy by Using an Ultra-slim Upper Endoscope for Patients with Retained Bile Duct Stones (with Video)”. Gastrointestinal Endoscopy. Elsevier BV. doi:10.1016/j.gie.2011.07.027.
- Moon, Jong Ho, Bong Min Ko, Hyun Jong Choi, Su Jin Hong, Young Koog Cheon, Young Deok Cho, Joon Seong Lee, Moon Sung Lee, and Chan Sup Shim. 2009. “Intraductal Balloon-guided Direct Peroral Cholangioscopy with an Ultraslim Upper Endoscope (with Videos)”. Gastrointestinal Endoscopy. Elsevier BV. doi:10.1016/j.gie.2008.11.019.
- Chen, Yang K., Mansour A. Parsi, Kenneth F. Binmoeller, Robert H. Hawes, Douglas K. Pleskow, Adam Slivka, Oleh Haluszka, et al.. 2011. “Single-operator Cholangioscopy in Patients Requiring Evaluation of Bile Duct Disease or Therapy of Biliary Stones (with Videos)”. Gastrointestinal Endoscopy. Elsevier BV. doi:10.1016/j.gie.2011.04.016.
- Itoi, Takao, Atsushi Sofuni, Fumihide Itokawa, Toshio Kurihara, Takayoshi Tsuchiya, Kentaro Ishii, Shujiro Tsuji, Nobuhito Ikeuchi, Junko Umeda, and Fuminori Moriyasu. 2010. “New Large-diameter Balloon-equipped Sphincterotome for Removal of Large Bile Duct Stones (with Videos)”. Gastrointestinal Endoscopy. Elsevier BV. doi:10.1016/j.gie.2010.06.018.
- Stefanidis, G, N Viazis, D Pleskow, S Manolakopoulos, L Theocharis, C Christodoulou, N Kotsikoros, et al.. 2011. “Large Balloon Dilation Vs. Mechanical Lithotripsy for the Management of Large Bile Duct Stones: A Prospective Randomized Study”. American Journal of Gastroenterology. Ovid Technologies (Wolters Kluwer Health). doi:10.1038/ajg.2010.421.
- Itoi, Takao, Fumihide Itokawa, Atsushi Sofuni, Toshio Kurihara, Takayoshi Tsuchiya, Kentaro Ishii, Shujiro Tsuji, Nobuhito Ikeuchi, and Fuminori Moriyasu. 2009. “Endoscopic Sphincterotomy Combined with Large Balloon Dilation Can Reduce the Procedure Time and Fluoroscopy Time for Removal of Large Bile Duct Stones”. The American Journal of Gastroenterology. Ovid Technologies (Wolters Kluwer Health). doi:10.1038/ajg.2008.67.
- Kiriyama, Seiki, Tadahiro Takada, Steven M. Strasberg, Joseph S. Solomkin, Toshihiko Mayumi, Henry A. Pitt, Dirk J. Gouma, et al.. 2013. “TG13 Guidelines for Diagnosis and Severity Grading of Acute Cholangitis (with Videos)”. Journal of Hepato-biliary-pancreatic Sciences. Wiley. doi:10.1007/s00534-012-0561-3.
- Moon, Jong Ho, Bong Min Ko, Hyun Jong Choi, Su Jin Hong, Young Koog Cheon, Young Deok Cho, Joon Seong Lee, Moon Sung Lee, and Chan Sup Shim. 2009. “Intraductal Balloon-guided Direct Peroral Cholangioscopy with an Ultraslim Upper Endoscope (with Videos)”. Gastrointestinal Endoscopy. Elsevier BV. doi:10.1016/j.gie.2008.11.019.
- Chen, Yang K., Mansour A. Parsi, Kenneth F. Binmoeller, Robert H. Hawes, Douglas K. Pleskow, Adam Slivka, Oleh Haluszka, et al.. 2011. “Single-operator Cholangioscopy in Patients Requiring Evaluation of Bile Duct Disease or Therapy of Biliary Stones (with Videos)”. Gastrointestinal Endoscopy. Elsevier BV. doi:10.1016/j.gie.2011.04.016.
- Lee JG. Diagnosis and management of acute cholangitis. Nat Rev Gastroenterol Hepatol. 2009 Sep;6(9):533-41. doi: 10.1038/nrgastro.2009.126. Epub 2009 Aug 4.
- Kiriyama S, Takada T, Strasberg SM, Solomkin JS, Mayumi T, Pitt HA, Gouma DJ, Garden OJ, Buchler MW, Yokoe M, Kimura Y, Tsuyuguchi T, Itoi T, Yoshida M, Miura F, Yamashita Y, Okamoto K, Gabata T, Hata J, Higuchi R, Windsor JA, Bornman PC, Fan ST, Singh H, de Santibanes E, Gomi H, Kusachi S, Murata A, Chen XP, Jagannath P, Lee S, Padbury R, Chen MF, Dervenis C, Chan AC, Supe AN, Liau KH, Kim MH, Kim SW; Tokyo Guidelines Revision Committee. TG13 guidelines for diagnosis and severity grading of acute cholangitis (with videos). J Hepatobiliary Pancreat Sci. 2013 Jan;20(1):24-34. doi: 10.1007/s00534-012-0561-3.
- Chen YK, Parsi MA, Binmoeller KF, Hawes RH, Pleskow DK, Slivka A, Haluszka O, Petersen BT, Sherman S, Deviere J, Meisner S, Stevens PD, Costamagna G, Ponchon T, Peetermans JA, Neuhaus H. Single-operator cholangioscopy in patients requiring evaluation of bile duct disease or therapy of biliary stones (with videos). Gastrointest Endosc. 2011 Oct;74(4):805-14. doi: 10.1016/j.gie.2011.04.016. Epub 2011 Jul 18.
- Chang WH, Chu CH, Wang TE, Chen MJ, Lin CC. Outcome of simple use of mechanical lithotripsy of difficult common bile duct stones. World J Gastroenterol. 2005 Jan 28;11(4):593-6. doi: 10.3748/wjg.v11.i4.593.
- Ara Sahakian 2018. "Papillary Balloon Dilation Versus Intraductal Lithotripsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03536247.
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