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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gentamicin | Active Comparator | adding 10mg gentamicin to every 10 ml of contrast media |
|
| Placebo | Placebo Comparator | Identical placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gentamicin | Drug | 10mg per 10ml of contrast media |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rasoul Sotudemanesh, MD | Tehran Medical University of Medical Science associate professor | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TUMS Digestive Disease Research Center | Tehran | Tehran Province | 1411713135 | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23081843 | Derived | Norouzi A, Khatibian M, Afroogh R, Chaharmahali M, Sotoudehmanesh R. The effect of adding gentamicin to contrast media for prevention of cholangitis after biliary stenting for non-calculous biliary obstruction, a randomized controlled trial. Indian J Gastroenterol. 2013 Jan;32(1):18-21. doi: 10.1007/s12664-012-0208-y. Epub 2012 Oct 19. |
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Exclusion criteria were patients with biliary stones, patients who were candidate for surgical cure, and patients who were already febrile.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gentamicin | participitants for whom gentamicin with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography |
| FG001 | Placebo | participitants for whom identical placebo with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gentamicin | participitants for whom gentamicin with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography |
| BG001 | Placebo | participitants for whom identical placebo with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | participants | 72 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gentamicin | participitants for whom gentamicin with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography |
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No limitation other than small sample size
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rasoul sotoudehmanesh | Tehran medical university of science | (+98 21) 82414000 | 82415000 | r.sotudemanesh@gmail.com |
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| ID | Term |
|---|---|
| D002761 | Cholangitis |
| D002779 | Cholestasis |
| ID | Term |
|---|---|
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D005839 | Gentamicins |
| ID | Term |
|---|---|
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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| Placebo | Drug | Distilled water |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|
| Participants |
|
|
|
| 0 |
| 57 |
| 0 |
| 57 |
| EG001 | Placebo | participitants for whom identical placebo with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography | 0 | 57 | 0 | 57 |
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