Treatment Outcomes in Bile Duct Stones

NCT04145843 | Completed

• 1 other identifier: 1504680
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gallstone; Bile Duct Obstruction; Bile Duct Diseases

Outcome Measures

Primary Outcomes (1)

• Rate of ductal clearance at index endoscopic intervention.

  Percent of patients that achieve ductal clearance at the index intervention

  6 months

Secondary Outcomes (6)

• Total number of needed interventions

  6 months

• Procedure duration

  Index procedure

• Technical success

  Index procedure

• Adverse Events

  6 months

• Crossover to other therapeutic intervention

  6 months

Interventions

endoscopic retrograde cholangiopancreatography PROCEDURE

ERCP is a procedure that enables the physician to examine the pancreatic and bile ducts and remove gallstones.

Also known as: ERCP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participants will be selected from the patient population at the Center for interventional Endoscopy who have presented for treatment of bile duct stones.

You may qualify if:

• All patients with confirmed or suspected bile duct stones undergoing endoscopic therapy for treatment of bile duct stones
• Patients 18 years or over

You may not qualify if:

• Patients not undergoing endoscopic therapy for bile duct stones
• Patients \< 18 years of age

Sponsors & Collaborators

• AdventHealth: lead

Study Sites (1)

Center for Interventional Endoscopy

Orlando, Florida, 32803, United States

Location

Related Publications (10)

• 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.

  PMID: 30979521 BACKGROUND

• 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.

  PMID: 27631594 BACKGROUND

• 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.

  PMID: 29399609 BACKGROUND

• 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.

  PMID: 29074446 BACKGROUND

• 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.

  PMID: 29572696 BACKGROUND

• 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.

  PMID: 22387254 BACKGROUND

• 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.

  PMID: 22748241 BACKGROUND

• 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.

  PMID: 28753698 BACKGROUND

• 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.

  PMID: 28866457 BACKGROUND

• 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.

  PMID: 16923479 BACKGROUND

MeSH Terms

Conditions

Gallstones; Cholestasis; Bile Duct Diseases

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Muhammad Hasan, MD

  AdventHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: October 31, 2019
• Study Start: November 6, 2019
• Primary Completion: April 5, 2022
• Study Completion: April 5, 2022
• Last Updated: July 12, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)