With this trial we want to compare both somatostatin analogues, octreotide and lanreotide, in one trial, so we can see whether there is a difference in effect on liver volume in patients with polycystic livers. Furthermore, we want to find the…
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in liver volume from baseline to 24 weeks.
Secondary outcome
Change in kidney volume from baseline to 24 weeks, change in symptoms from
baseline to 24 weeks, change in quality of life from baseline to 24 weeks,
proportion of patients that have any reduction of liver volume at 24 weeks, and
adverse events during the 24 weeks.
Background summary
Polycystic liver disease is a disorder in which at least 20 liver cysts are
present. It can occur in isolated autosomal dominant polycystic liver disease
(PCLD) and in autosomal dominant polycystic kidney disease (ADPKD). De symptoms
are due to the mass effect of the liver and include abdominal pain and
distension, nauseau, vomiting, and early satiety. Until recent, no medical
treatment was available for polycystic livers, but a few trials showed that the
somatostatin analogues octreotide and lanreotide reduced liver volume in
patients with a polycystic liver. However, there seems to be a difference in
the effect on liver volume between octreotide and lanreotide. The liver volume
of the patients who received octreotide 40 mg every 28 days during one year
reduced with 4.9%, while the liver volume of the patients who received
lanreotide 120 mg every 28 days during a half year reduced with 2.9%.
Study objective
With this trial we want to compare both somatostatin analogues, octreotide and
lanreotide, in one trial, so we can see whether there is a difference in effect
on liver volume in patients with polycystic livers. Furthermore, we want to
find the optimal dosage of both octreotide and lanreotide.
Study design
This will be a randomized, open, parallel, clinical trial.
Intervention
The patients will be randomized to either the octreotide or the lanreotide
group and will receive every 28 days for 24 weeks octreotide 60 mg or
lanreotide 120 mg, respectively.
Study burden and risks
The treatment and CT scans go with certain risks, but in earlier trials with
these drugs, the side effects were relatively mild and the patients had a
subjectively reduction of their complaints. In conclusion, treatment with
somatostatin analogues looks like an elegant alternative to surgical procedures
that go with considerable morbidity.
Geert Grooteplein-Zuid 10
6525 GA Nijmegen
NL
Geert Grooteplein-Zuid 10
6525 GA Nijmegen
NL
Listed location countries
Age
Inclusion criteria
- patients with polycystic liver disease
- at least 18 years of age
- Informed consent, patients are willing and able to comply with the study drug regimen and all other study requirements
Exclusion criteria
- kidney transplantation
- renal failure requiring hemodialysis
- use of oral contraceptives or estrogen suppletion
- women who are pregnant or breastfeeding
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2009-017849-57-NL |
| CCMO | NL30902.091.09 |