Evidence map›Paper›PMID 35216547›Full record

ArticleBMC gastroenterology2022

Protocol for a randomized controlled multicenter trial assessing the efficacy of leuprorelin for severe polycystic liver disease: the AGAINST-PLD study.

S E Aapkes, L H P Bernts, A P van den Berg, M van den Berg, H Blokzijl, A E P Cantineau, M D A van Gastel, R J de Haas, P Kappert, R U Müller and 5 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC gastroenterology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.9field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 6 institutions in 4 countries.

S E AapkesDepartment of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
L H P BerntsDepartment of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands.
A P van den BergDepartment of Gastroenterology and Hepatology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
M van den BergDepartment of Obstetrics and Gynecology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
H BlokzijlDepartment of Gastroenterology and Hepatology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
A E P CantineauDepartment of Obstetrics and Gynecology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
M D A van GastelDepartment of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
R J de HaasDepartment of Radiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
P KappertDepartment of Radiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
R U MüllerDepartment II of Internal Medicine and Center for Molecular Medicine Cologne, Faculty of Medicine, University Hospital Cologne, University of Cologne, Kerpener Straße 62, 50937, Cologne, Germany.
F NevensDepartment of Gastroenterology and Hepatology, Universiteitsziekenhuis Leuven, Leuven, Belgium.
R TorraDepartment of Nephrology, Fundacio Puigvert, Barcelona, Spain.
A VisserDepartment of Applied Health Sciences, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
J P H DrenthDepartment of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands.
R T GansevoortDepartment of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. r.t.gansevoort@umcg.nl.
University of Groningen · NLUniversity Medical Center Groningen · NLRadboud University Nijmegen · NLPuigvert Foundation · ESUniversitair Ziekenhuis Leuven · BEUniversity of Cologne · DE

Funding

AbbVie SA-003047 (ACA-NETH-20-01)ZonMw 10140261910001
6 · The paper itself

Abstract

backgroundIn patients with severe polycystic liver disease (PLD), there is a need for new treatments. Estrogens and possibly other female sex hormones stimulate growth in PLD. In some patients, liver volume decreases after menopause. Female sex hormones could therefore be a target for therapy. The AGAINST-PLD study will examine the efficacy of the GnRH agonist leuprorelin, which blocks the production of estrogen and other sex hormones, to reduce liver growth in PLD.

methodsThe AGAINST-PLD study is an investigator-driven, multicenter, randomized controlled trial. Institutional review board (IRB) approval was received at the University Medical Center of Groningen and will be collected in other sites before opening these sites. Thirty-six female, pre-menopausal patients, with a very large liver volume for age (upper 10% of the PLD population) and ongoing liver growth despite current treatment options will be randomized to direct start of leuprorelin or to 18 months standard of care and delayed start of leuprorelin. Leuprorelin is given as 3.75 mg subcutaneously (s.c.) monthly for the first 3 months followed by 3-monthly depots of 11.25 mg s.c. The trial duration is 36 months. MRI scans to measure liver volume will be performed at screening, 6 months, 18 months, 24 months and 36 months. In addition, blood will be drawn, DEXA-scans will be performed and questionnaires will be collected. This design enables comparison between patients on study treatment and standard of care (first 18 months) and within patients before and during treatment (whole trial). Main outcome is annualized liver growth rate compared between standard of care and study treatment. Secondary outcomes are PLD disease severity, change in liver growth within individuals and (serious) adverse events. The study is designed as a prospective open-label study with blinded endpoint assessment (PROBE). DISCUSSION: In this trial, we combined the expertise of hepatologist, nephrologists and gynecologists to study the effect of leuprorelin on liver growth in PLD. In this way, we hope to stop liver growth, reduce symptoms and reduce the need for liver transplantation in severe PLD. Trial registration Eudra CT number 2020-005949-16, registered at 15 Dec 2020. https://www.clinicaltrialsregister.eu/ctr-search/search?query=2020-005949-16 .

Indexed as

LeuprolideLiver DiseasesCystsFemaleHumansMulticenter Studies as TopicProspective StudiesRandomized Controlled Trials as TopicLeuprolideEstrogenGnRHaPolycystic liver disease

Identifiers

PMID35216547
PMCPMC8876117
OpenAlexW4214611895

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.