AzTrials
AzTrials

GallstoneNCT04145843

Treatment Outcomes in Bile Duct Stones

An observational study of Gallstone and Bile Duct Obstruction, run by AdventHealth at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
endoscopic retrograde cholangiopancreatography
Type of treatment
Surgery or procedure
How many people
42 participants
Where
1 siteUnited States
Study dates
6 Nov 2019to 5 Apr 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Center for Interventional Endoscopy

    Orlando, Florida, 32803

Other trials in United States

About this study

Official title: Registry to Evaluate the Outcomes Following Algorithmic Approach in the Endoscopic Treatment of Bile Duct Stones

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.

Read the detailed 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.

Being tested
endoscopic retrograde cholangiopancreatography
Medical subject headings
Gallstones, Cholestasis, Bile Duct Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • endoscopic retrograde cholangiopancreatographyProcedure or surgery

    Also called ERCP

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of ductal clearance at index endoscopic intervention.

    Percent of patients that achieve ductal clearance at the index intervention

    Measured: 6 months

Secondary outcomes (6)

  1. Total number of needed interventions

    Total number of endoscopic interventions required for ductal clearance

    Measured: 6 months

  2. Procedure duration

    Length of procedure in minutes

    Measured: Index procedure

  3. Technical success

    Success of the procedures as documented by a yes or no.

    Measured: Index procedure

  4. Adverse Events

    Total number of adverse events that occurred

    Measured: 6 months

  5. Crossover to other therapeutic intervention

    Need for interventional radiology or surgical intervention for bile duct stone removal as documented by yes or no.

    Measured: 6 months

  6. Procedural costs

    Total costs measured in US dollars for the procedure

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2019
  2. Study start6 Nov 2019
  3. Primary completion5 Apr 2022
  4. Study completion5 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04145843
Sponsor's protocol ID
1504680
Status last verified
Jul 2023
First submitted
29 Oct 2019
Last updated
12 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30979521

  • 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.

    PubMed 27631594

  • 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.

    PubMed 29399609

  • 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.

    PubMed 29074446

  • 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.

    PubMed 29572696

  • 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.

    PubMed 22387254

  • 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.

    PubMed 22748241

  • 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.

    PubMed 28753698

  • 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.

    PubMed 28866457

  • 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.

    PubMed 16923479

Questions about this trial

What is this clinical trial studying?

An observational study of Gallstone and Bile Duct Obstruction, run by AdventHealth at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of ductal clearance at index endoscopic intervention. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04145843, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.

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