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Clinical Trials/NCT04145843
NCT04145843
Completed
Not Applicable

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

AdventHealth1 site in 1 country42 target enrollmentNovember 6, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gallstone
Sponsor
AdventHealth
Enrollment
42
Locations
1
Primary Endpoint
Rate of ductal clearance at index endoscopic intervention.
Status
Completed
Last Updated
2 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
November 6, 2019
End Date
April 5, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Procedure duration(Index procedure)
  • Technical success(Index procedure)
  • Adverse Events(6 months)
  • Crossover to other therapeutic intervention(6 months)
  • Procedural costs(6 months)
  • Total number of needed interventions(6 months)

Study Sites (1)

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