Choledocholithiasis Clinical Trial
Official title:
Prospective Study of Bacteremia and Infection Rates Following Cholangioscopy With the Spyglass Cholangioscope
The aim of this study is to prospectively evaluate the frequency of bacteremia after ERCP/cholangioscopy using the Spyglass Direct Visualization System. In addition, the frequency of cholangitis/sepsis despite use of post procedural antibiotics will be studied.
Rates of bacteremia (bacterial seeding of the blood) following ERCP's range from 6.4% to
18.0%. However, infectious complications of cholangitis/sepsis occur in only 0.5%- 3.0% of
patients undergoing this procedure. The Spyglass Direct Visualization System allows
cholangioscopy with direct visualization of the bile duct during ERCP by using a specialized
small caliber endoscope. During the Spyglass portion of the procedure, saline is introduced
into the bile duct to to irrigate the biliary system, in order to distend the biliary ducts
and to improve visualization by clearing contrast, pus and stone debris. Saline irrigation
may increase intrabiliary pressures and may therefore theoretically increase the risk for
bacteremia and infection.
The effect of Spyglass cholangioscopy and biliary irrigation on the frequency of
bacteremia/post cholangioscopy infections is unknown and has not previously been studied.
The aim of this study is to prospectively evaluate the frequency of bacteremia after
ERCP/cholangioscopy using the Spyglass system.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03536247 -
Papillary Balloon Dilation Versus Intraductal Lithotripsy
|
N/A | |
Recruiting |
NCT05035433 -
Effect of the Sequence of Dilatation and Lithotripsy on the Treatment of Choledocholithiasis With ERCP
|
N/A | |
Not yet recruiting |
NCT06060002 -
Role of Prophylactic Biliary Stent in Reducing the Recurrence of Choledocholithiasis
|
N/A | |
Recruiting |
NCT06041113 -
Recurrent Extrahepatic Bile Duct Stones as a Late Complication of ERCP in Patients With Coexisting Intra- and Extrahepatic Bile Duct Stones
|
||
Completed |
NCT02461147 -
Prospective Validation of "Cholecystectomy First" Strategy for Gallstone Migration
|
||
Recruiting |
NCT00416234 -
Laparoendoscopic Rendez Vous Versus Standard Two Stage Approach for the Management of Cholelithiasis/Choledocholithiasis
|
N/A | |
Active, not recruiting |
NCT05592795 -
Explore the Effects and Mechanisms of ERCP and EST on Biliary Microecology
|
||
Recruiting |
NCT05056506 -
EPLBD With Limited EST vs. EPLBD for Choledocholithiasis
|
N/A | |
Completed |
NCT02515474 -
Comparison of LCBDE vs ERCP + LC for Choledocholithiasis
|
N/A | |
Recruiting |
NCT05429203 -
Comparison of Duodenoscope With Single-use Distal Cover and the Conventional Reusable Duodenoscope
|
N/A | |
Completed |
NCT01824186 -
Trial Comparing Pain in Single-incision Laparoscopic Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy
|
N/A | |
Completed |
NCT02647593 -
The Clinical Characteristics of the Patients With Choledocholithiasis Without Cholangitis
|
||
Not yet recruiting |
NCT06066372 -
Application of Machine Learning Models to Reduce Need for Diagnostic EUS or MRCP in Patients With Intermediate Likelihood of Choledocholithiasis
|
||
Completed |
NCT04716166 -
Incentive Spirometry and Upper Abdominal Laparoscopic Surgery
|
N/A | |
Completed |
NCT03074201 -
Prospective Evaluation of the Ability of Spyglass Cholangioscopy to Facilitate Radiation Free ERCP
|
N/A | |
Withdrawn |
NCT01475864 -
Prospective Evaluation of the Covered Self-expandable Metal Stents (CSEMS) for Incomplete Biliary Stone Clearance
|
N/A | |
Recruiting |
NCT06265311 -
IDUS in CBD Stone Recurrence High Risk Patients
|
N/A | |
Completed |
NCT02870686 -
EUS Guided ERCP in Bile Duct Stone Removal
|
N/A | |
Recruiting |
NCT05611840 -
RCT on Robotic vs. Endo-laparoscopic Approach for Difficult Choledocholithiasis
|
N/A | |
Recruiting |
NCT03102281 -
Microbiomes in Patients of Recurrent Common Bile Duct Stones
|
N/A |