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OpenTrials
Completed

NCT Number: NCT04145843

Treatment Outcomes in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for Interventional Endoscopy

Orlando, Florida, 32803, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Endoscopic retrograde cholangiopancreatography

Procedure

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

Other names: ERCP

Primary outcomes

  1. Rate of ductal clearance at index endoscopic intervention.

    Time frame: 6 months

    Percent of patients that achieve ductal clearance at the index intervention

Secondary outcomes

  1. Total number of needed interventions

    Time frame: 6 months

    Total number of endoscopic interventions required for ductal clearance

  2. Procedure duration

    Time frame: Index procedure

    Length of procedure in minutes

  3. Technical success

    Time frame: Index procedure

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

  4. Adverse Events

    Time frame: 6 months

    Total number of adverse events that occurred

  5. Crossover to other therapeutic intervention

    Time frame: 6 months

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

  6. Procedural costs

    Time frame: 6 months

    Total costs measured in US dollars for the procedure

Sponsors and collaborators

Lead sponsor

AdventHealth

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 31, 2019
Registry last updated
Jul 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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