Papillary Balloon Dilation Versus Intraductal Lithotripsy

NCT03536247 | Unknown DMC

• 1 other identifier: HS-17-00448
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

Our aim is to compare the efficacy, safety, procedural time required, and costs of a strategy initially employing cholangioscopy guided intraductal lithotripsy (laser/electrohydraulic lithtripsy (EHL)) versus a strategy initially using papillary dilation for removal of large bile duct stones.

Conditions

Choledocholithiasis

Keywords

bile duct stones; choledocholithiasis; ERCP; endoscopic retrograde cholangiopancreatograhy

Outcome Measures

Primary Outcomes (1)

• First procedure stone clearance

  Entire stone\[s\] removed in first procedure

  2 hours

Secondary Outcomes (2)

• Adverse Events

  1 week

• Procedure Time

  2 hours

Study Arms (2)

Intraductal lithotripsy

ACTIVE COMPARATOR

Cholangioscopy enables therapeutic intervention including intracorporeal electro-hydraulic and laser lithotripsy for biliary stone disease with favorable efficacy and safety.

Procedure: Initial therapy with intraductal lithotripsy

Papillary Balloon dilation

ACTIVE COMPARATOR

Balloon dilation of the Ampulla of Vater after a small sphincterotomy is an alternative technique that allows for removal of large bile duct stones in a safe and effective manner.

Procedure: Initial therapy with papillary balloon dilation

Interventions

Initial therapy with papillary balloon dilation PROCEDURE

patients will first undergo papillary dilation

Also known as: papillary dilation

Papillary Balloon dilation

Initial therapy with intraductal lithotripsy PROCEDURE

patients will first undergo intraductal laser or electrohydraulic lithrotripsy

Intraductal lithotripsy

Eligibility Criteria

• Age: 18 Years - 115 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years and older
• Undergoing ERCP at LAC+Medical Center or Keck Hospital of USC for the standard indication of bile duct stones with evidence of a large stone (\>1cm) demonstrated either on Ultrasound, computed tomography, prior ERCP, or magnetic resonance imaging.

You may not qualify if:

• Patients Under the age of 18
• Patients with biliary malignancy
• Prior biliary diversion surgery
• Prior gastric bypass surgery
• Patients who are incarcerated
• Patients who are unable to give consent
• Patients who pregnant

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (2)

Keck Hospital of USC

Los Angeles, California, 90033, United States

RECRUITING

Los Angeles County + USC Medical Center

Los Angeles, California, 90033, United States

RECRUITING

Related Publications (9)

• 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.

  PMID: 15641153 BACKGROUND

• Moon JH, Ko BM, Choi HJ, Hong SJ, Cheon YK, Cho YD, Lee JS, Lee MS, Shim CS. Intraductal balloon-guided direct peroral cholangioscopy with an ultraslim upper endoscope (with videos). Gastrointest Endosc. 2009 Aug;70(2):297-302. doi: 10.1016/j.gie.2008.11.019. Epub 2009 Apr 25.

  PMID: 19394010 BACKGROUND

• 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.

  PMID: 19652653 BACKGROUND

• Kim HI, Moon JH, Choi HJ, Lee JC, Ahn HS, Song AR, Lee TH, Cho YD, Park SH, Kim SJ. Holmium laser lithotripsy under direct peroral cholangioscopy by using an ultra-slim upper endoscope for patients with retained bile duct stones (with video). Gastrointest Endosc. 2011 Nov;74(5):1127-32. doi: 10.1016/j.gie.2011.07.027. Epub 2011 Sep 29.

  PMID: 21963070 BACKGROUND

• 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.

  PMID: 21762903 BACKGROUND

• Stefanidis G, Viazis N, Pleskow D, Manolakopoulos S, Theocharis L, Christodoulou C, Kotsikoros N, Giannousis J, Sgouros S, Rodias M, Katsikani A, Chuttani R. Large balloon dilation vs. mechanical lithotripsy for the management of large bile duct stones: a prospective randomized study. Am J Gastroenterol. 2011 Feb;106(2):278-85. doi: 10.1038/ajg.2010.421. Epub 2010 Nov 2.

  PMID: 21045816 BACKGROUND

• Itoi T, Itokawa F, Sofuni A, Kurihara T, Tsuchiya T, Ishii K, Tsuji S, Ikeuchi N, Moriyasu F. Endoscopic sphincterotomy combined with large balloon dilation can reduce the procedure time and fluoroscopy time for removal of large bile duct stones. Am J Gastroenterol. 2009 Mar;104(3):560-5. doi: 10.1038/ajg.2008.67. Epub 2009 Jan 27.

  PMID: 19174779 BACKGROUND

• Itoi T, Sofuni A, Itokawa F, Kurihara T, Tsuchiya T, Ishii K, Tsuji S, Ikeuchi N, Umeda J, Moriyasu F. New large-diameter balloon-equipped sphincterotome for removal of large bile duct stones (with videos). Gastrointest Endosc. 2010 Oct;72(4):825-30. doi: 10.1016/j.gie.2010.06.018.

  PMID: 20883862 BACKGROUND

• 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.

  PMID: 23307001 BACKGROUND

MeSH Terms

Conditions

Choledocholithiasis; Cholecystolithiasis

Condition Hierarchy (Ancestors)

Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis; Gallbladder Diseases

Study Officials

• Ara Sahakian, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

• James Buxbaum, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Serna

CONTACT

323-409-6939; Jessica.Serna@med.usc.edu

James Buxbaum, MD

CONTACT

323-409-6939; James.Buxbaum@med.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants in the study will be blinded to treatment arm. Care providers and Investigators will be unblinded to treated arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: Patients will be randomized using a pre-generated randomization schedule with concealed allocation in a 1:1 assignment to initial cholangioscopy guided lithotrispy or papillary dilation. Randomization will be blocked in groups of 12.

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: May 24, 2018
• Study Start: September 7, 2018
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 15, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)