CholangitisNCT01148693
Gentamicin in Preventing Post Endoscopic Retrograde Cholangiopancreatography (ERCP) Cholangitis in Non-calculus Stenting
A study testing gentamicin in people with Cholangitis, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cholangitis
- What is being tested?
- gentamicin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteIran
- Study dates
- Dec 2009to Dec 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with non-calculus biliary obstruction who need palliative treatment
Who cannot join
- Fever (> 37.8 Celsius)
- Leukocytosis (WBC > 10,000 /mm3)
- Not candidate for surgical cure of obstruction
Trial locations and contacts
1 site in 1 country.
Iran1 site
TUMS Digestive Disease Research Center
Tehran, Tehran Province, 1411713135
About this study
Official title: Comparing Addition of Gentamicin vs. Placebo in Preventing Post ERCP Cholangitis in Non-calculus Stenting
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.
- Conditions
- Cholangitis
- Being tested
- gentamicin, Placebo
- Keywords
- Cholangitis; Cholangiopancreatography, Endoscopic Retrograde; stents; cholestasis
- Medical subject headings
- Cholangitis, Cholestasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gentamicinDrug
Also called Brand name: Gentamicin
10mg per 10ml of contrast media
PlaceboDrug
Distilled water
| Study group | Role | What they receive |
|---|---|---|
| gentamicin | Active comparator | adding 10mg gentamicin to every 10 ml of contrast media Receives: Drug: gentamicin |
| Placebo | Placebo comparator | Identical placebo Receives: Drug: gentamicin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startDec 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CholangitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alireza Norouzi, Tehran University of Medical Sciences
- Investigators
- Rasoul Sotudemanesh, MD, Study chair, Tehran Medical University of Medical Science associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01148693
- Sponsor's protocol ID
- DDRC-88/19
- Status last verified
- Jul 2011
- First submitted
- 19 Jun 2010
- Last updated
- 20 Sep 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 23081843
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Addition of Gentamicin vs. Placebo in Preventing Post ERCP Cholangitis in Non-calculus Stenting
- ClinicalTrials.gov ID
- NCT01148693
- Acronym / sponsor ID
- DDRC-88/19
- Conditions
- Cholangitis
- Keywords
- Cholangitis; Cholangiopancreatography, Endoscopic Retrograde; stents; cholestasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Posted 22 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gentamicin | Active comparator | Drug: gentamicinadding 10mg gentamicin to every 10 ml of contrast media |
| Placebo | Placebo comparator | Drug: gentamicin, Drug: PlaceboIdentical placebo |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with non-calculus biliary obstruction who need palliative treatment
Key exclusion criteria (3 listed)
- Fever (> 37.8 Celsius)
- Leukocytosis (WBC > 10,000 /mm3)
- Not candidate for surgical cure of obstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gentamicinAlso: Brand name: Gentamicin10mg per 10ml of contrast media | Drug | Placebo, gentamicin |
| PlaceboDistilled water | Drug | Placebo |
Primary outcome
Number of Participants With Cholangitis
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23081843Norouzi 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rasoul Sotudemanesh, MD study chair
Tehran Medical University of Medical Science associate professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gentamicin in people with Cholangitis, run by Tehran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Cholangitis (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01148693, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2011.