Clinical Trials Logo

Clinical Trial Summary

An Endoscopic retrograde cholangio pancreatography (ERCP) with cholangioscopy (endoscope to directly visualize the bile duct ) is a procedure (a small flexible tube that is inserted into the participants mouth to the participants stomach and into the participants liver to visualize the bile duct) that is usually performed in patients for the following purposes : 1. The removal of all stones from the participants bile duct (if present). 2. Acquiring a tissue sample biopsy from any common bile mass to examine (if present). 3. Acquiring tissue sample biopsy from common bile duct narrowing (if present). However this procedure is associated with an increase risk of infection compared with the standard ERCP (ERCP without cholangioscopy). Previous studies have shown that despite the administration of antibiotics prior to these procedures, infection still occurs. This leads to a suspicion that other factors may be the cause in these infections. Factors such as age, race, gender and ethnicity have not been fully explored yet. This study aims to examine these factors in addition to others in patients who are undergoing ERCP with cholangioscopy as part of their routine medical care. This examination will allow us to bring out if any of the above mentioned factors may be involved in the development of an infection after ERCP with cholangioscopy.


Clinical Trial Description

ERCP with cholangioscopy is becoming a widespread technique to treat complicated choledocholithiasis, document CBD clearance after stone extraction and to assess biliary duct strictures. During the procedure, a large amount of water is used to irrigate the common bile duct in order to improve visualization. This can result in CBD distension and may increase the possibility of bacterial translocation and subsequent bacteremia or septicemia. According to the ASGE guidelines, antibiotic prophylaxis prior to ERCP is indicated when biliary duct obstruction is suspected prior to ERCP procedures . There are no current guidelines addressing antibiotics prophylaxis prior to ERCP with cholangioscopy. The investigators recent ACG funded prospective trial examining the risk of bacteremia in ERCP with cholangioscopy have shown the presence of bacteremia in 8.8% of patients undergoing ERCP with cholangioscopy, thus prompting the use of prophylactic antibiotics in patients undergoing these procedures. However the study was not powered to examine factors associated with increased bacteremia and infectious complications. In spite of the use of pre-procedural antibiotics in some of the published series, infectious complications such as cholangitis and sepsis were still reported after the procedure. In the landmark study by Chen et al, in which 297 patients prospectively underwent single-operator cholangioscopy in 15 referral centers across the US and Europe, nine patients developed cholangitis. Antibiotics administration prior to the procedures was left to the standard of practice at each participating institution and was not reported in this study. In a retrospective study by Kalaitzakis et al, nine out of 179 patients who underwent cholangioscopy for CBD stricture or treatment of CBD stones developed cholangitis. Cholangitis was fatal in one case and required prolonged hospitalization in the other case. All patients in this study had antibiotics prophylaxis prior to the procedure. Manta et al had one case of cholangitis in their series of 52 patients who underwent cholangioscopy for CBD stricture. Two patients out of 87 patients had cholangitis in the study by Osania et al., which prospectively included patients who underwent cholangioscopy for CBD stricture. The cholangitis rate in the previously mentioned studies ranged from 2% to 5%. This high rate of post procedure cholangitis in spite of the use of pre-procedural antibiotics suggest that post procedure antibiotics are of value in subsets of patients who will undergo ERCP with cholangioscopy. In the investigators preliminary data, bacteremia rate was significantly higher in patients with CBD strictures who had cholangioscopy with biopsies. It is possible that strictures could lead to colonization of biliary epithelium with bacteria. Obtaining biopsies may cause disruption of the endothelial barrier allowing bacterial translocation. In addition, cholangitis was seen in one patient in the investigators cohort who underwent laser lithotripsy for large stone. Choledocholithiasis is another source of bacterial colonization which could increase the risk of cholangitis after ERCP and cholangioscopy. The investigators protocol objective is to examine the factors that are potentially associated with increased frequency of bacteremia and subsequent infectious complication after ERCP with cholangioscopy in a setting of uniform pre-procedure antibiotics. The investigators hypothesize that biopsy of CBD strictures and Laser Lithotripsy are risk factors for increased rate of bacteremia and infectious complications after ERCP with cholangioscopy. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02543957
Study type Observational
Source Baylor College of Medicine
Contact
Status Withdrawn
Phase
Start date September 2015
Completion date December 2020

See also
  Status Clinical Trial Phase
Completed NCT03894046 - Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex Phase 3
Active, not recruiting NCT03354338 - Amoxicillin to Prevent Bacteria and Inflammatory Biomarkers After Intensive Periodontal Therapy Phase 2
Completed NCT02210169 - RCT of Continuous Versus Intermittent Infusion of Vancomycin in Neonates N/A
Completed NCT01410578 - The Value of sTREM-1, PCT, and CRP as Markers for the Detection of Sepsis and Bacteremia Among Patients With a FUO N/A
Terminated NCT00428051 - Colombia Epidemiologic Surveillance Study N/A
Completed NCT00609375 - Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen Phase 4
Completed NCT00177736 - Pharmacodynamic Parameters of Two Different Doses of Cefepime Phase 4
Terminated NCT00108433 - Linezolid in the Treatment of Hemodialysis Patients With Catheter-Related Gram-Positive Bloodstream Infections Phase 3
Completed NCT00571259 - Prophylactic Antimicrobial Catheter Lock Phase 4
Completed NCT00027248 - Safety and Efficacy of MBI 226 for the Prevention of Central Venous Catheter-Related Bloodstream Infections Phase 3
Completed NCT05585463 - Safety of Acupuncture and Intracutaneous Needles in Pediatric Cancer Patients: a Retrospective Study (ACUSAFE2021)
Recruiting NCT05950984 - Medical Device (MD) Derived Pharmacokinetic (PK) Parameters for Vancomycin (MD-PK)
Completed NCT03148769 - Spanish Bacteriemia Cohort 2016: Epidemiology, Clinical Management and Prognosis Factors
Completed NCT02536352 - Effect of Supplementation of Fluoride on Maternal Periodontal Health, Preterm Delivery, and Perinatal Well-Being Early Phase 1
Completed NCT02869191 - Blood Cultures's Profitability in Intensive Care Unit
Terminated NCT01734694 - Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients Phase 4
Completed NCT01179022 - Incidence of Bacteremia Following Argon Plasma Coagulation in Patients With Endobronchial Lesions N/A
Recruiting NCT00404625 - Infections Caused by ESbL-Producing Enterobacteriaceae in Italy N/A
Completed NCT00398411 - Moxifloxacin in the Prevention of Bacteremia After High-dose Chemotherapy and Transplantation of Peripheral Stem Cells Phase 3
Recruiting NCT00901602 - Lebanese Interhospital Pneumococcal Surveillance Program