Treatment Outcomes in Bile Duct Stones

Study 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.

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

Conditions
-----------------
Gallstone, Bile Duct Obstruction, Bile Duct Diseases

Intervention / Treatment
-----------------
* Procedure: endoscopic retrograde cholangiopancreatography


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: endoscopic retrograde cholangiopancreatography|ERCP is a procedure that enables the physician to examine the pancreatic and bile ducts and remove gallstones.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of ductal clearance at index endoscopic intervention. | Percent of patients that achieve ductal clearance at the index intervention | 6 months | 

Secondary Outcome Measures

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