Evidence map›Paper›PMID 37408814›Full record

ArticleJournal of clinical and translational hepatology2023

Randomized Trial of Ciclosporin with 2-h Monitoring vs. Tacrolimus with Trough Monitoring in Liver Transplantation: DELTA Study.

Bastian N Ruijter, Akin Inderson, Aad P van den Berg, Herold J Metselaar, Jeroen Dubbeld, Maarten E Tushuizen, Robert J Porte, Wojciech Polak, Danny van der Helm, Marjolein van Reeven and 2 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of clinical and translational hepatology, 2023. 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
–field-weighted citation impact
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.

  1. Article
  2. Article
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

12 authors.

Bastian N RuijterDepartment of Gastroenterology and Hepatology, LUMC Transplantation Center, Leiden University Medical Center, Leiden, The Netherlands.
Akin IndersonDepartment of Gastroenterology and Hepatology, LUMC Transplantation Center, Leiden University Medical Center, Leiden, The Netherlands.
Aad P van den BergDepartment of Gastroenterology and Hepatology, University Medical Center Groningen, Groningen, The Netherlands.
Herold J MetselaarDepartment of Gastroenterology and Hepatology, Erasmus MC Transplant Institute, Erasmus Medical Center, Rotterdam, The Netherlands.
Jeroen DubbeldDepartment of Surgery, LUMC Transplantation Center, Leiden University Medical Center, Leiden, The Netherlands.
Maarten E TushuizenDepartment of Gastroenterology and Hepatology, LUMC Transplantation Center, Leiden University Medical Center, Leiden, The Netherlands.
Robert J PorteDepartment of Surgery, Section HPB Surgery and Liver Transplantation, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Wojciech PolakDepartment of Surgery, Division of HPB and Transplant Surgery, Erasmus MC Transplant Institute, Erasmus Medical Center, Rotterdam, The Netherlands.
Danny van der HelmDepartment of Gastroenterology and Hepatology, LUMC Transplantation Center, Leiden University Medical Center, Leiden, The Netherlands.
Marjolein van ReevenDepartment of Surgery, Division of HPB and Transplant Surgery, Erasmus MC Transplant Institute, Erasmus Medical Center, Rotterdam, The Netherlands.
Mar Rodriguez-GirondoDepartment of Biomedical Data Sciences, Leiden University Medical Center, Leiden, The Netherlands.
Bart van HoekDepartment of Gastroenterology and Hepatology, LUMC Transplantation Center, Leiden University Medical Center, Leiden, The Netherlands.ORCID https://orcid.org/0000-0001-6527-764X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background and Aims: Previous trials comparing cyclosporine and tacrolimus after liver transplantation (LT) showed conflicting results. Most used trough monitoring for cyclosporine (C0), leading to less accurate dosing than with 2-h monitoring (C2). Only one larger trial compared C2 with tacrolimus based on trough level (T0) after LT, with similar treated biopsy-proven acute rejection (tBPAR) and graft loss, while a smaller trial had less tBPAR with C2 compared to T0. Therefore, it is still unclear which calcineurin inhibitor is preferred after LT. We aimed to demonstrate superior efficacy (tBPAR), tolerability, and safety of C2 or T0 after first LT. Methods: Patients after first LT were randomized to C2 or T0. tBPAR, patient- and graft survival, safety and tolerability were the main endpoints, with analysis by Fisher test, Kaplan-Meier survival analysis and log-rank test. Results: In intention-to-treat analysis 84 patients on C2 and 85 on T0 were included. Cumulative incidence of tBPAR C2 vs. T0 was 17.7% vs. 8.4% at 3 months ( Conclusions: In the first year after LT immunosuppression with T0 leads to less tBPAR and better patient-/re-transplant-free survival as compared to C2.

Indexed as

Adverse effectsCiclosporinLiver transplantationOutcomeRandomized controlled trialRejectionRenal functionSurvivalTacrolimus

Identifiers

PMID37408814
PMCPMC10318291

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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.