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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04145843
Other study ID # 1504680
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 6, 2019
Est. completion date April 5, 2022

Study information

Verified date July 2023
Source AdventHealth
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This registry is to evaluate the procedural and clinical outcomes in patients undergoing endoscopic treatment of bile duct stones when utilizing an algorithmic management approach.


Description:

Gallstone diseases are common, affecting 20 million patients in the United States with associated costs of over US $6 billion. Common bile duct (CBD) stones in turn occur in 15-20% patients with gallstone disease and require treatment due to risk of infection and pancreatitis. Endoscopic treatment via endoscopic retrograde cholangiopancreatography (ERCP) is the treatment modality of choice in CBD stones. The most simple treatment techniques include biliary sphincterotomy and stone extraction via the use of standard devices such as a stone retrieval balloons or stone retrieval baskets. However, patients with difficult bile duct stones require advanced maneuvers namely mechanical lithotripsy, large balloon sphincteroplasty (LBS) of the major duodenal papilla and single operator cholangioscopy-guided lithotripsy (SOC-LL). Currently, there are no standardized treatment approaches in the management of CBD stones, especially in the management of difficult CBD stones. Therefore, ERCP in patients with difficult CBD stones can be inefficient and prolonged with use of multiple devices and techniques. In an effort to standardize the management of bile duct stones, we have devised an algorithm for the treatment of bile duct stones using current standard of care methods, taking into account the size of bile duct stones, size of bile duct and availability of endoscopic expertise. The objective of this registry is to evaluate the procedural and clinical outcomes in patients undergoing endoscopic treatment of bile duct stones when utilizing an algorithmic management approach.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date April 5, 2022
Est. primary completion date April 5, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. All patients with confirmed or suspected bile duct stones undergoing endoscopic therapy for treatment of bile duct stones 2. Patients 18 years or over Exclusion Criteria: 1. Patients not undergoing endoscopic therapy for bile duct stones 2. Patients < 18 years of age

Study Design


Intervention

Procedure:
endoscopic retrograde cholangiopancreatography
ERCP is a procedure that enables the physician to examine the pancreatic and bile ducts and remove gallstones.

Locations

Country Name City State
United States Center for Interventional Endoscopy Orlando Florida

Sponsors (1)

Lead Sponsor Collaborator
AdventHealth

Country where clinical trial is conducted

United States, 

References & Publications (10)

Aburajab M, Dua K. Endoscopic Management of Difficult Bile Duct Stones. Curr Gastroenterol Rep. 2018 Mar 23;20(2):8. doi: 10.1007/s11894-018-0613-1. — View Citation

ASGE Standards of Practice Committee; Buxbaum JL, Abbas Fehmi SM, Sultan S, Fishman DS, Qumseya BJ, Cortessis VK, Schilperoort H, Kysh L, Matsuoka L, Yachimski P, Agrawal D, Gurudu SR, Jamil LH, Jue TL, Khashab MA, Law JK, Lee JK, Naveed M, Sawhney MS, Thosani N, Yang J, Wani SB. ASGE guideline on the role of endoscopy in the evaluation and management of choledocholithiasis. Gastrointest Endosc. 2019 Jun;89(6):1075-1105.e15. doi: 10.1016/j.gie.2018.10.001. Epub 2019 Apr 9. — View Citation

Brewer Gutierrez OI, Bekkali NLH, Raijman I, Sturgess R, Sejpal DV, Aridi HD, Sherman S, Shah RJ, Kwon RS, Buxbaum JL, Zulli C, Wassef W, Adler DG, Kushnir V, Wang AY, Krishnan K, Kaul V, Tzimas D, DiMaio CJ, Ho S, Petersen B, Moon JH, Elmunzer BJ, Webster GJM, Chen YI, Dwyer LK, Inamdar S, Patrick VB, Attwell A, Hosmer A, Ko C, Maurano A, Sarkar A, Taylor LJ, Gregory MH, Strand DS, Raza A, Kothari S, Harris JP, Kumta NA, Manvar A, Topazian MD, Lee YN, Spiceland CM, Trindade AJ, Bukhari MA, Sanaei O, Ngamruengphong S, Khashab MA. Efficacy and Safety of Digital Single-Operator Cholangioscopy for Difficult Biliary Stones. Clin Gastroenterol Hepatol. 2018 Jun;16(6):918-926.e1. doi: 10.1016/j.cgh.2017.10.017. Epub 2017 Oct 24. — View Citation

Buxbaum J, Sahakian A, Ko C, Jayaram P, Lane C, Yu CY, Kankotia R, Laine L. Randomized trial of cholangioscopy-guided laser lithotripsy versus conventional therapy for large bile duct stones (with videos). Gastrointest Endosc. 2018 Apr;87(4):1050-1060. doi: 10.1016/j.gie.2017.08.021. Epub 2017 Sep 1. — View Citation

Cote GA, Singh S, Bucksot LG, Lazzell-Pannell L, Schmidt SE, Fogel E, McHenry L, Watkins J, Lehman G, Sherman S. Association between volume of endoscopic retrograde cholangiopancreatography at an academic medical center and use of pancreatobiliary therapy. Clin Gastroenterol Hepatol. 2012 Aug;10(8):920-4. doi: 10.1016/j.cgh.2012.02.019. Epub 2012 Mar 2. — View Citation

Franzini T, Moura RN, Bonifacio P, Luz GO, de Souza TF, Dos Santos MEL, Rodela GL, Ide E, Herman P, Montagnini AL, D'Albuquerque LAC, Sakai P, de Moura EGH. Complex biliary stones management: cholangioscopy versus papillary large balloon dilation - a randomized controlled trial. Endosc Int Open. 2018 Feb;6(2):E131-E138. doi: 10.1055/s-0043-122493. Epub 2018 Feb 1. — View Citation

Karsenti D, Coron E, Vanbiervliet G, Privat J, Kull E, Bichard P, Perrot B, Quentin V, Duriez A, Cholet F, Subtil C, Duchmann JC, Lefort C, Hudziak H, Koch S, Granval P, Lecleire S, Charachon A, Barange K, Cesbron EM, De Widerspach A, Le Baleur Y, Barthet M, Poincloux L. Complete endoscopic sphincterotomy with vs. without large-balloon dilation for the removal of large bile duct stones: randomized multicenter study. Endoscopy. 2017 Oct;49(10):968-976. doi: 10.1055/s-0043-114411. Epub 2017 Jul 28. — View Citation

Ozawa N, Yasuda I, Doi S, Iwashita T, Shimizu M, Mukai T, Nakashima M, Ban T, Kojima I, Matsuda K, Matsuda M, Ishida Y, Okabe Y, Ando N, Iwata K. Prospective randomized study of endoscopic biliary stone extraction using either a basket or a balloon catheter: the BasketBall study. J Gastroenterol. 2017 May;52(5):623-630. doi: 10.1007/s00535-016-1257-2. Epub 2016 Sep 8. — View Citation

Rosenkranz L, Patel SN. Endoscopic retrograde cholangiopancreatography for stone burden in the bile and pancreatic ducts. Gastrointest Endosc Clin N Am. 2012 Jul;22(3):435-50. doi: 10.1016/j.giec.2012.05.007. Epub 2012 Jun 12. — View Citation

Varadarajulu S, Kilgore ML, Wilcox CM, Eloubeidi MA. Relationship among hospital ERCP volume, length of stay, and technical outcomes. Gastrointest Endosc. 2006 Sep;64(3):338-47. doi: 10.1016/j.gie.2005.05.016. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of ductal clearance at index endoscopic intervention. Percent of patients that achieve ductal clearance at the index intervention 6 months
Secondary Total number of needed interventions Total number of endoscopic interventions required for ductal clearance 6 months
Secondary Procedure duration Length of procedure in minutes Index procedure
Secondary Technical success Success of the procedures as documented by a yes or no. Index procedure
Secondary Adverse Events Total number of adverse events that occurred 6 months
Secondary Crossover to other therapeutic intervention Need for interventional radiology or surgical intervention for bile duct stone removal as documented by yes or no. 6 months
Secondary Procedural costs Total costs measured in US dollars for the procedure 6 months
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