Treatment Outcomes in Bile Duct Stones

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04145843
Study type	Observational
Source	AdventHealth
Contact
Status	Completed
Phase
Start date	November 6, 2019
Completion date	April 5, 2022

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT05475964` - The Role of Endoscopic Ultrasound in Evaluation of Patients With Indefinite Cause of Bile Duct Dilatation	N/A
Recruiting	`NCT06010576` - Endoscopic Ultrasound-guided Rendezvous Versus Precut Papillotomy	N/A
Completed	`NCT02917408` - Retrospective Study About Primary Biliary Cholangitis During January 2001 to July 2016 at West China Hospital
Completed	`NCT00930410` - Intra-ductal Confocal Endomicroscopy for Characterization of Pancreas and Bile Duct Tumor	N/A
Completed	`NCT05600270` - Angled-tip vs. Straight-tip Guidewire in Biliary Cannulation	N/A
Completed	`NCT05263752` - Evaluation of Safety and Efficacy of NvisionVLE® Imaging Low Profile System in Patients With Bile Duct Disease
Recruiting	`NCT04929821` - UNITY-B A Prospective, Multicentric, Single-arm Study to Evaluate the Safety and Efficacy of the UNITY-B Biodegradable Balloon-Expandable Biliary Stent System in Subjects With Biliary Strictures	N/A
Recruiting	`NCT06115655` - A Single-center, Prospective Cohort Study on the Differentiation of Benign and Malignant Bile Duct Stenosis Based on Bile and Peripheral Blood cfDNA Methylation Profiles
Active, not recruiting	`NCT00270868` - Efficacy of Double Wire Technique in Difficult Cases of Common Bile Duct Cannulation in ERCP (UDOGUIA-04)	N/A
Enrolling by invitation	`NCT03951324` - Volumetric Laser Endomicroscopy's (VLE) Diagnostic Accuracy Validation Study: Impact on Clinical Management Study
Recruiting	`NCT06340620` - EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope	N/A
Not yet recruiting	`NCT06170632` - Flare Type Self-expandable Metal Stents (SEMS) vs Plastic Stent for the Treatment of Difficult Common Bile Duct Stone	N/A
Withdrawn	`NCT03678480` - A Study of HTD1801 in Adolescents With Primary Sclerosing Cholangitis (PSC)	Phase 2
Enrolling by invitation	`NCT06364865` - AE05ML Device for ML Hem-o-lok Polymer Clip Delivery in Laparoscopic Surgical Procedures Observational Registery Study
Completed	`NCT01493076` - Safety and Efficacy of a Newly Developed Baby-sphincterotome for Bile Duct Cannulation	N/A
Active, not recruiting	`NCT05014347` - Patient Reported Experience in Endoscopic Ultrasound
Completed	`NCT04580940` - SpyGlass™ Discover Percutaneous
Recruiting	`NCT02882451` - Impact of Pinaverium Bromide on Bile Duct and Pancreatic Duct Cannulation During Endoscopic Retrograde Cholangiopancreatography	N/A
Recruiting	`NCT05457101` - Validation of an AI-based Biliopancreatic EUS Navigation System for Real-time Quality Improvement: A Prospective, Single-center, Randomized Controlled Trial	N/A
Recruiting	`NCT04556019` - Results of Surgical Treatment of the Hepatobiliopancreatic Surgical Unit