Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

The ARISE Trial Compares Whether Giving Routine Steroid Replacement or Using Targeted Blood Tests to Guide Replacement Better Protects Certain Patients From Adrenal Insufficiency After the Removal of a Diseased Adrenal Gland. (ARISE)

23. april 2026 opdateret af: King's College Hospital NHS Trust

Adrenalectomy Recovery and Sustained Insufficiency After Steroid Exposure (ARISE): A Randomised Controlled Trial

Adrenalectomy is an operation to remove one of the adrenal glands. It is commonly performed to treat adrenal tumours or conditions that cause excess hormone production. The adrenal glands produce important hormones, including cortisol and aldosterone, which help regulate blood pressure, metabolism and the body's response to stress.

After adrenalectomy, some patients may develop adrenal insufficiency, a condition in which the body does not produce enough of these essential hormones. In severe cases, this can lead to an Addisonian (adrenal) crisis, a life-threatening emergency that can cause shock, organ failure and death if not treated promptly.

The risk of adrenal insufficiency after surgery depends largely on cortisol levels before the operation. In patients with Cushing's syndrome, where there is excessive cortisol production, the risk of adrenal insufficiency after adrenalectomy is almost 100%. For this reason, these patients routinely receive steroid replacement treatment after surgery to replace missing hormones and prevent adrenal crisis.

For other patients undergoing adrenalectomy, the best management approach is less clear. Patients with mild autonomous cortisol secretion (MACS) have a moderate risk of adrenal insufficiency - around 50-65%. Patients with normal cortisol secretion (NCS) may also develop adrenal insufficiency because one adrenal gland has been removed, occurring in around 20-37% of cases.

International medical guidelines currently disagree on how best to manage these patients after surgery. Some recommend measuring cortisol levels the morning after surgery and treating only if levels are low, while others recommend giving steroid treatment to all patients with mild cortisol excess. There is currently no clear guidance for patients with normal cortisol secretion.

This study will compare these management strategies to determine which approach best reduces the risk of adrenal insufficiency after adrenalectomy. The study will be conducted at King's College Hospital and will run for approximately two years.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

96

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Recommended for adrenalectomy following adrenal multidisciplinary discussion
  • ≥18 years old
  • Ability to consent

Exclusion Criteria:

  • Overt Cushing's syndrome
  • Pregnancy
  • Pre-existing confirmed adrenal insufficiency
  • Pre-existing steroid therapy (including high dose steroid inhalers)
  • History of adrenalectomy
  • Bilateral disease as assessed radiologically and clinically

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Empirical Steroid Replacement (Standard Care)
Participants receive routine, empirical steroid replacement therapy following adrenalectomy regardless of post-operative cortisol levels. This follows the current King's College Hospital standard of care and European Society of Endocrinology / ENSAT guidance.
Routine administration of Hydrocortisone (e.g., 50mg-100mg IV followed by oral tapering doses) starting immediately post-adrenalectomy even in presence of normal >300nmol/L cortisol reading on post-operative day 1.
Eksperimentel: Targeted Replacement (Intervention)
Participants receive targeted steroid replacement based on biochemical assessment (Post-Operative Day 1 cortisol levels). Participants with normal cortisol levels do not receive steroid replacement. This follows American Association of Endocrine Surgeons guidelines.
Administration of Hydrocortisone is withheld and the patient is monitored if Post-Operative Day 1 (POD1) serum cortisol level is >300nmol/L and patient is asymptomatic.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Sustained Adrenal Insufficiency at 3 Months
Tidsramme: 3 months post-adrenalectomy
The proportion of patients who fail a biochemical assessment of adrenal function. Adrenal insufficiency is defined as a peak cortisol level <420 nmol/L following a 250 µg Short Synacthen Test (SST)
3 months post-adrenalectomy

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. september 2028

Studieafslutning (Anslået)

1. december 2028

Datoer for studieregistrering

Først indsendt

23. april 2026

Først indsendt, der opfyldte QC-kriterier

23. april 2026

Først opslået (Faktiske)

30. april 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. april 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRAS 368153

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Binyresygdom

Kliniske forsøg med Empirical Hydrocortisone Protocol

Abonner