Treatment Outcomes in Bile Duct Stones

Completed

• Conditions: Gallstone; Bile Duct Obstruction; Bile Duct Diseases

• Registration Number: NCT04145843
• Lead Sponsor: AdventHealth

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.

Study Timeline

• Study First Submitted: 2019-10-29
• Study First Submitted QC: 2019-10-29
• Study First Posted: 2019-10-31
• Study Start: 2019-11-06
• Primary Completion: 2022-04-05
• Study Completion: 2022-04-05
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-11
• Last Update Posted: 2023-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of ductal clearance at index endoscopic intervention.	6 months	Percent of patients that achieve ductal clearance at the index intervention

Secondary Outcome Measures

Name	Time	Method
Procedure duration	Index procedure	Length of procedure in minutes
Technical success	Index procedure	Success of the procedures as documented by a yes or no.
Adverse Events	6 months	Total number of adverse events that occurred
Crossover to other therapeutic intervention	6 months	Need for interventional radiology or surgical intervention for bile duct stone removal as documented by yes or no.
Procedural costs	6 months	Total costs measured in US dollars for the procedure
Total number of needed interventions	6 months	Total number of endoscopic interventions required for ductal clearance

Trial Locations

Locations (1)

Center for Interventional Endoscopy; 🇺🇸 Orlando, Florida, United States