Clinical trial NCT04145843: Treatment Outcomes in Bile Duct Stones
Official title: Registry to Evaluate the Outcomes Following Algorithmic Approach in the Endoscopic Treatment of Bile Duct Stones
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gallstone
Bile Duct Obstruction
Bile Duct Diseases
Lead sponsor: AdventHealth
Sponsor class: OTHER
First posted: 2019-10-31
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of ductal clearance at index endoscopic intervention.
timeFrame: 6 months
Secondary outcomes:
measure: Total number of needed interventions
timeFrame: 6 months
measure: Procedure duration
timeFrame: Index procedure
measure: Technical success
timeFrame: Index procedure
measure: Adverse Events
timeFrame: 6 months
measure: Crossover to other therapeutic intervention
timeFrame: 6 months
measure: Procedural costs
timeFrame: 6 months
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Center for Interventional Endoscopy
state: Florida
Study officials:
affiliation: AdventHealth
name: Muhammad Hasan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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