Trial Outcomes & Findings for Assessing Portal Hypertension With Methacetin Breath Test (NCT NCT02143778)

Last Updated: 2022-12-20

Results Overview

Clinically significant portal hypertension is defined as Hepatic Venous Pressure Gradient (HVPG)\>=10mmHg, whereby the portal pressure leaving the liver is measured by using a balloon catheter before and after a wedge. The difference of the pressure between the wedge and the free is the hepatic venous pressure gradient. Methacetin breath test is hypothesized to also identify CSPH and the agreement to the reference standard (HVPG) will be assessed in this study.

Recruitment status

COMPLETED

Study phase

Target enrollment

246 participants

Primary outcome timeframe

1 hour

Results posted on

2022-12-20

Participant Flow

Participant milestones

Participant milestones
Measure	Compensated Cirrhotic Patients A methacetin breath test will be performed on patients who are undergoing the HVPG procedure due to their clinical indication of compensated cirrhosis. Methacetin Breath Test: 13C labelled methacetin solution for breath test monitoring
Overall Study STARTED	246
Overall Study COMPLETED	243
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Compensated Cirrhotic Patients A methacetin breath test will be performed on patients who are undergoing the HVPG procedure due to their clinical indication of compensated cirrhosis. Methacetin Breath Test: 13C labelled methacetin solution for breath test monitoring
Overall Study Withdrawal by Subject	2
Overall Study Device malfunction	1

Baseline Characteristics

Assessing Portal Hypertension With Methacetin Breath Test

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Compensated Cirrhotic Patients n=246 Participants A methacetin breath test will be performed on patients who are undergoing the HVPG procedure due to their clinical indication of compensated cirrhosis. Methacetin Breath Test: 13C labelled methacetin solution for breath test monitoring
Age, Continuous	60.6 years STANDARD_DEVIATION 9.27 • n=5 Participants
Sex: Female, Male Female	93 Participants n=5 Participants
Sex: Female, Male Male	153 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	242 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants
Region of Enrollment France	40 participants n=5 Participants
Region of Enrollment Switzerland	9 participants n=5 Participants
Region of Enrollment Spain	158 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 hour

Population: Compensated cirrhotic patients with CSPH based on breath test compared to CSPH from HVPG (reference standard)

Outcome measures

Outcome measures
Measure	Compensated Cirrhotic Patients With CSPH n=246 Participants A methacetin breath test will be performed on patients who are undergoing the HVPG procedure due to their clinical indication of compensated cirrhosis. Methacetin Breath Test: 13C labelled methacetin solution for breath test monitoring
CSPH (Clinically Significant Portal Hypertension)	81.82 percentage of agreement Interval 74.22 to 89.42

SECONDARY outcome

Timeframe: 1 hour

Population: Compensated cirrhotic Patients with Severe Portal Hypertension based on MBT compared to HVPG (reference standard)

Hepatic Venous Pressure Gradient greater than 12 (SPH) is an indicator of bleeding varices. whereby the portal pressure leaving the liver is measured by using a balloon catheter before and after a wedge. The difference of the pressure between the wedge and the free is the hepatic venous pressure gradient. Methacetin breath test is hypothesized to also identify SPH and the agreement to the reference standard (HVPG) will be assessed in this study.

Outcome measures

Outcome measures
Measure	Compensated Cirrhotic Patients With CSPH n=246 Participants A methacetin breath test will be performed on patients who are undergoing the HVPG procedure due to their clinical indication of compensated cirrhosis. Methacetin Breath Test: 13C labelled methacetin solution for breath test monitoring
Hepatic Venous Pressure Gradient (HVPG)>=12; Severe Portal Hypertension (SPH)	76.39 percentage of agreement Interval 66.58 to 86.2

Adverse Events

Compensated Cirrhotic Patients

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Compensated Cirrhotic Patients n=246 participants at risk A methacetin breath test will be performed on patients who are undergoing the HVPG procedure due to their clinical indication of compensated cirrhosis. Methacetin Breath Test: 13C labelled methacetin solution for breath test monitoring
Gastrointestinal disorders Severe Diarrhea	0.41% 1/246 • Number of events 1 • The Methacetin used in the breath test has a high extraction rate and is removed after less than 48 hours. Follow up was done for 48 hours after breath test. After 30 days another follow up phone call was made.

Other adverse events

Other adverse events
Measure	Compensated Cirrhotic Patients n=246 participants at risk A methacetin breath test will be performed on patients who are undergoing the HVPG procedure due to their clinical indication of compensated cirrhosis. Methacetin Breath Test: 13C labelled methacetin solution for breath test monitoring
Infections and infestations UTI	0.81% 2/246 • Number of events 2 • The Methacetin used in the breath test has a high extraction rate and is removed after less than 48 hours. Follow up was done for 48 hours after breath test. After 30 days another follow up phone call was made.

Additional Information

Clinical Trial Manager

Exalenz Bisocience

Phone: 97289737500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place