Cholangitis
Conditions
Keywords
Cholangitis; Cholangiopancreatography, Endoscopic Retrograde; stents; cholestasis
Brief summary
Cholangitis is the most prevalent infectious complication of ERCP. Stenting of biliary strictures and stenosis is one of important risk factors for post-ERCP cholangitis. Adding antibiotics to contrast media has proposed in some studies for prevention of cholangitis but remains controversial. In this study we compare effect of adding gentamicin versus placebo in preventing cholangitis in patients who undergone endoscopic stenting for non-calculus strictures and stenosis.
Interventions
DRUGgentamicin
10mg per 10ml of contrast media
DRUGPlacebo
Distilled water
Sponsors
Tehran University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with non-calculus biliary obstruction who need palliative treatment
Exclusion criteria
* Fever (\> 37.8 Celsius) * Leukocytosis (WBC \> 10,000 /mm3) * Not candidate for surgical cure of obstruction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Cholangitis | 72 hours | After Endoscopic Retrograde CholangioPancreatography (ERCP) in 3 following days we check all participants for syptoms of cholangitis (fever, chills, right upper qudrant (RUQ) pain, leukocytosis) and ruling out other diagnoses than cholangitis |
Countries
Iran
Participant flow
Recruitment details
Between December 2009 and October 2010 all patients with non-calculus biliary obstructions including cholangiocarcinoma, pancreatic cancer, sclerosing cholangitis, postsurgical benign biliary strictures and biliary stenosis due to metastatic cancers to biliary tree who were candidate for palliative stenting, were included in this study.
Pre-assignment details
Exclusion criteria were patients with biliary stones, patients who were candidate for surgical cure, and patients who were already febrile.
Participants by arm
| Arm | Count |
|---|---|
| Gentamicin participitants for whom gentamicin with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography | 70 |
| Placebo participitants for whom identical placebo with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography | 67 |
| Total | 137 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Attempts for cannulation were failed | 13 | 10 |
Baseline characteristics
| Characteristic | Placebo | Gentamicin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 28 Participants | 30 Participants | 58 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants | 40 Participants | 79 Participants |
| Age Continuous | 66.74 years STANDARD_DEVIATION 14.145 | 62.59 years STANDARD_DEVIATION 15.082 | 64.62 years STANDARD_DEVIATION 14.533 |
| Region of Enrollment Iran, Islamic Republic of | 67 participants | 70 participants | 137 participants |
| Sex: Female, Male Female | 20 Participants | 28 Participants | 48 Participants |
| Sex: Female, Male Male | 47 Participants | 42 Participants | 89 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 57 | 0 / 57 |
| serious Total, serious adverse events | 0 / 57 | 0 / 57 |
Outcome results
Primary
Number of Participants With Cholangitis
After Endoscopic Retrograde CholangioPancreatography (ERCP) in 3 following days we check all participants for syptoms of cholangitis (fever, chills, right upper qudrant (RUQ) pain, leukocytosis) and ruling out other diagnoses than cholangitis
Time frame: 72 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gentamicin | Number of Participants With Cholangitis | 5 participants |
| Placebo | Number of Participants With Cholangitis | 5 participants |
Comparison: Null hypothesis: Adding gentamicin to contrast medium during ERCP has no relation with postERCP cholangitis Power calculation: 80%p-value: <0.05Fisher Exact