Factors Associated With Increased Risk of Bacteremia and Cholangitis in ERCP With Cholangioscopy
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease, Gastrointestinal, Hematology |
| Therapuetic Areas: | Gastroenterology, Hematology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 1/18/2019 |
| Start Date: | September 2015 |
| End Date: | December 2019 |
| Contact: | Mohamed O. Othman, MD |
| Email: | Mohamed.Othman@bcm.edu |
| Phone: | 713-798-0950 |
A Prospective Study of the Factors Associated With Increased Risk of Bacteremia and Cholangitis in ERCP With Cholangioscopy
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.
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.
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.
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.
Inclusion Criteria:
1. Adult patients (18-80) who are undergoing ERCP with cholangioscopy to ensure the
clearance of the CBD from stones.
2. Adult patients (18-80) who are undergoing ERCP with cholangioscopy for CBD stone
removal using laser lithotripsy.
3. Adult patients (18-80) who are undergoing ERCP with cholangioscopy for CBD mass.
4. Adult patients (18-80) who are undergoing ERCP with cholangioscopy for tissue
acquisition from CBD strictures with biopsies.
Exclusion Criteria:
1. Patients younger than 18 yrs old or older than 80 yrs.
2. Pregnant patients.
3. Patient with ascending cholangitis, pneumonia or urinary tract infection
We found this trial at
1
site
1200 Moursund Street
Houston, Texas 77030
Houston, Texas 77030
(713) 798-4951
Phone: 713-798-0950
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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