Trial Outcomes & Findings for Gentamicin in Preventing Post Endoscopic Retrograde Cholangiopancreatography (ERCP) Cholangitis in Non-calculus Stenting (NCT NCT01148693)

Last Updated: 2011-09-20

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

114 participants

Primary outcome timeframe

72 hours

Results posted on

2011-09-20

Participant Flow

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.

Exclusion criteria were patients with biliary stones, patients who were candidate for surgical cure, and patients who were already febrile.

Participant milestones

Participant milestones
Measure	Gentamicin participitants for whom gentamicin with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography	Placebo participitants for whom identical placebo with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography
Overall Study STARTED	70	67
Overall Study COMPLETED	57	57
Overall Study NOT COMPLETED	13	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Gentamicin participitants for whom gentamicin with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography	Placebo participitants for whom identical placebo with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography
Overall Study Attempts for cannulation were failed	13	10

Baseline Characteristics

Gentamicin in Preventing Post Endoscopic Retrograde Cholangiopancreatography (ERCP) Cholangitis in Non-calculus Stenting

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gentamicin n=70 Participants participitants for whom gentamicin with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography	Placebo n=67 Participants participitants for whom identical placebo with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography	Total n=137 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants	39 Participants n=7 Participants	79 Participants n=5 Participants
Age, Categorical >=65 years	30 Participants n=5 Participants	28 Participants n=7 Participants	58 Participants n=5 Participants
Age Continuous	62.59 years STANDARD_DEVIATION 15.082 • n=5 Participants	66.74 years STANDARD_DEVIATION 14.145 • n=7 Participants	64.62 years STANDARD_DEVIATION 14.533 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	20 Participants n=7 Participants	48 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	47 Participants n=7 Participants	89 Participants n=5 Participants
Region of Enrollment Iran, Islamic Republic of	70 participants n=5 Participants	67 participants n=7 Participants	137 participants n=5 Participants

PRIMARY outcome

Timeframe: 72 hours

Outcome measures

Outcome measures
Measure	Gentamicin n=57 Participants patients for whom 10m/10cc of gentamicin is added to contrast during ERCP	Placebo n=57 Participants patients for whom distilled water is added to contrast during ERCP
Number of Participants With Cholangitis	5 participants	5 participants

Adverse Events

Gentamicin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Rasoul sotoudehmanesh

Tehran medical university of science

Phone: (+98 21) 82414000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place