Trial Outcomes & Findings for Elastography of the Liver in Cystic Fibrosis Patients. Diagnostic and Prognostic Aspects (NCT NCT02603666)

Results Overview

Elastographic values given in kPa by Fibroscan. All patients undergo elastographic measurement of the liver and ultrasound of the liver. The grade of fibrosis is to be established by setting the cut-off for cystic fibrosis patients.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

130 participants

Primary outcome timeframe

Within 28 days in connection with their annual evaluation at a single point of time

Results posted on

2016-12-30

Participant Flow

Outpatient department, between 04/Feb/2012 and 04/Apr/2014

Participant milestones

Participant milestones
Measure	Elastography Fibroscan elastography device for evaluation of liver disease in CF patients. Fibroscan: Ultrasound by specific wavelength developed for elastography, repeated measures according to the manufacturer's instructions.
Overall Study STARTED	130
Overall Study COMPLETED	130
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Elastography of the Liver in Cystic Fibrosis Patients. Diagnostic and Prognostic Aspects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Elastography n=130 Participants Fibroscan elastography device for evaluation of liver disease in CF patients. Fibroscan: Ultrasound by specific wavelength developed for elastography, repeated measures according to the manufacturer's instructions.
Age, Categorical <=18 years	57 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	71 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Gender Female	73 Participants n=5 Participants
Gender Male	57 Participants n=5 Participants
Region of Enrollment Sweden	130 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 28 days in connection with their annual evaluation at a single point of time

Elastographic values given in kPa by Fibroscan. All patients undergo elastographic measurement of the liver and ultrasound of the liver. The grade of fibrosis is to be established by setting the cut-off for cystic fibrosis patients.

Outcome measures

Outcome measures
Measure	Elastography n=130 Participants Fibroscan elastography device for evaluation of liver disease in CF patients. Fibroscan: Ultrasound by specific wavelength developed for elastography, repeated measures according to the manufacturer's instructions.
Elastographic Value in kPa Measured by Fibroscan	4.7 kPa Interval 4.3 to 5.0

Adverse Events

Elastography

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

Ferenc Karpati M.D., Ph.D., Senior Consultant

Karolinska University Hospital, Huddinge, 141 86 Stockholm

Phone: +46858580000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place