Investigate whether *T1-mapping of the liver with the liver specific MRI contrast agent Gd-EOB-DTPA allows measurement of the change in liver function after ERCP treatment of a dominant stricture in PSC patients.
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Quantitative MRI: *T1
- MRCP/ERCP: location and degree of bile duct obstruction
Secondary outcome
- Laboratory values: e.g. AP, gGT, billirubin (as measure of cholestasis)
- Liver fat percentages (MR fat mapping)
- Bile composition (using in vitro, high-field MR Spectroscopy)
Background summary
Primary sclerosing cholangitis (PSC) is a disease of unknown origin that
presents with inflammation of the intra- and extrahepatic bile ducts, which
eventually become sclerotic and obstructed. Often, the acute obstruction caused
by 'dominant strictures' results in accumulation of bile fluids that cause
jaundice and pruritus (itch). In the course of time the ongoing inflammatory
processes damage the liver parenchyma and cause fibrosis and eventually liver
cirrhosis, culminating in end-stage liver disease, for which the only remaining
treatment option is a liver transplant.
Current methods and techniques (laboratory values, qualitative imaging methods,
ERCP) are lacking in terms of their ability to accurately monitor (PSC) disease
activity and liver parenchyma function. Recent studies employing the liver
specific MRI contrast agent Gd-EOB-DTPA have shown promising results. MRI with
Gd-EOD-DTPA may be able to quantitatively and non-invasively (without liver
biopsy) measure liver parenchyma function.
As mentioned, PSC patients often present with an acute dominant stricture and
complain of severe pruritus and jaundice. In these patients an urgent MRI with
MRCP (dedicated type of MRI-scan to image the bile ducts) is indicated. If a
stricture is visible on MRCP, an ERCP will follow to treat the dominant
stricture with balloon dilatation. The majority of patients improve rapidly
after ERCP.
The hypothesis behind this study is that the function of the liver parenchyma
drained by the obstructed bile duct is temporarily reduced during the acute
moment and that this function improves after ERCP treatment. By applying new,
quantitative MRI-techniques such as *T1-mapping before and after ERCP-treatment
we will investigate this hypothesis and try to correlate clinical (and
laboratory) improvement with changes in the results of these quantitative
MRI-scans.
Study objective
Investigate whether *T1-mapping of the liver with the liver specific MRI
contrast agent Gd-EOB-DTPA allows measurement of the change in liver function
after ERCP treatment of a dominant stricture in PSC patients.
Study design
Mono-centric observational study
Study burden and risks
Participating in this study leads to no immediate advantage for the individual
participant, though treating physicians will be notified of liver function
(*T1) which they potentially can use to tailor individual treatment plans. It
is especially important to evaluate whether *T1-mapping of the liver using
Gd-EOB-DTPA can be used to derive functional information of the liver
parenchyma by comparing MRI results before and after ERCP treatment to clinical
improvement (or deterioration) of PSC patients presenting with acute dominant
stricture. If this is possible, *T1-mapping could be used as a tool to monitor
disease activity of PSC (and other liver diseases) and liver patients in
general and PSC patients in particular could profit notably of this and future
research.
The additional burden for subjects consists of 2 x 5 minutes of extra MRI
scan-time (added to regular clinical MRI-scans of 30 minutes).
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- 18 years or older
- Proven prior diagnosis of Primary Sclerosing Cholangitis (based on laboratory and clinical findings and biopsy and/or ERCP and/or MRCP results)
- Clinically suspected dominant stricture causing acute pruritus and jaundice with indication for urgent MRCP and ERCP
- Written, informed consent
Exclusion criteria
- Contraindications for MRI
- Known haemochromatosis
- Chronic renal insufficiency or eGFR < 30 ml/min/1.73 m2
- Known or family history of congenital prolonged QT-syndrome
- Prior history of arrhythmia after the use of cardiac repolarisation time prolonging drugs
- Current use of cardiac repolarisation time prolonging drugs (such as class 3 anti-arrhythmic drugs (such as amiodaron or sotalol)
- Prior history of allergic reaction to gadolinium-containing compounds
- Prior history of asthma bronchiale
- Current use of beta blockers
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL50329.018.14 |