NCT01148693

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 22, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
9 months until next milestone

Results Posted

Study results publicly available

August 22, 2011

Completed
Last Updated

September 20, 2011

Status Verified

July 1, 2011

Enrollment Period

1 year

First QC Date

June 19, 2010

Results QC Date

February 18, 2011

Last Update Submit

September 18, 2011

Conditions

Cholangitis

Keywords

Cholangitis; Cholangiopancreatography, Endoscopic Retrograde; stents; cholestasis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

gentamicin

ACTIVE COMPARATOR

adding 10mg gentamicin to every 10 ml of contrast media

Drug: gentamicin

Placebo

PLACEBO COMPARATOR

Identical placebo

Drug: gentamicinDrug: Placebo

Interventions

gentamicinDRUG

10mg per 10ml of contrast media

Also known as: Brand name: Gentamicin
Placebogentamicin
PlaceboDRUG

Distilled water

Placebo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with non-calculus biliary obstruction who need palliative treatment

You may not qualify if:

  • Fever (\> 37.8 Celsius)
  • Leukocytosis (WBC \> 10,000 /mm3)
  • Not candidate for surgical cure of obstruction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TUMS Digestive Disease Research Center

Tehran, Tehran Province, 1411713135, Iran

Location

Related Publications (1)

  • 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.

    PMID: 23081843DERIVED

MeSH Terms

Conditions

CholangitisCholestasis

Interventions

Gentamicins

Condition Hierarchy (Ancestors)

Bile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

AminoglycosidesGlycosidesCarbohydrates

Limitations and Caveats

No limitation other than small sample size

Results Point of Contact

Title
Dr. Rasoul sotoudehmanesh
Organization
Tehran medical university of science
r.sotudemanesh@gmail.com
(+98 21) 82414000

Study Officials

  • Rasoul Sotudemanesh, MD

    Tehran Medical University of Medical Science associate professor

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
gastroenterology fellow in DDRC

Study Record Dates

First Submitted

June 19, 2010

First Posted

June 22, 2010

Study Start

December 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

September 20, 2011

Results First Posted

August 22, 2011

Record last verified: 2011-07

Locations

IR(1)