Center for Interventional Endoscopy
Orlando, Florida, 32803, United States
NCT Number: NCT04145843
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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Notify Me18 year and older
All sexes
Observational
Orlando, Florida, 32803, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ERCP is a procedure that enables the physician to examine the pancreatic and bile ducts and remove gallstones.
Other names: ERCP
Time frame: 6 months
Percent of patients that achieve ductal clearance at the index intervention
Time frame: 6 months
Total number of endoscopic interventions required for ductal clearance
Time frame: Index procedure
Length of procedure in minutes
Time frame: Index procedure
Success of the procedures as documented by a yes or no.
Time frame: 6 months
Total number of adverse events that occurred
Time frame: 6 months
Need for interventional radiology or surgical intervention for bile duct stone removal as documented by yes or no.
Time frame: 6 months
Total costs measured in US dollars for the procedure
AdventHealth
Other
Registry to Evaluate the Outcomes Following Algorithmic Approach in the Endoscopic Treatment of Bile Duct Stones
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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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