Veilig gebruik van contrastmiddelen

Initiatief: NVvR Aantal modules: 48

Veilig gebruik van contrastmiddelen bij patiënten met een feochromocytoom of paraganglioom

Uitgangsvraag

Wat voor strategie wordt aanbevolen om contrastmiddel veilig toe te dienen bij patiënten met een feochromocytoom of paraganglioom?

 

Deze klinische vraag bevat de volgende subvraag:

  • Hoe zou intra-arterieel en intraveneus contrast moeten worden toegediend bij patiënten met een feochromocytoom of paraganglioom?

Aanbeveling

Profylactische therapie met een adrenerge α-receptorblokker (± adrenerge ß-receptorblokker) is niet geïndiceerd bij intraveneuze toediening van jodiumhoudend CM bij patiënten met een feochromocytoom of paraganglioom.

 

Profylactische therapie met een adrenerge α-receptorblokker (± adrenerge ß-receptorblokker) is niet geïndiceerd bij intra-arteriële toediening van jodiumhoudend CM bij patiënten met een feochromocytoom of paraganglioom.

 

Gadoliniumhoudend CM en CM voor echografisch onderzoek kunnen veilig worden gebruikt bij patiënten met een feochromocytoom of paraganglioom.

Overwegingen

Pheochromocytomas and paragangliomas (PPGL) are rare neuroendocrine tumours derived from chromaffin tissue of the adrenal medulla and the extra-adrenal sympathetic paraganglia in the thorax and abdomen, respectively (Nölting, 2022). The annual incidence of PPGL in The Netherlands is approximately 100 new cases, with about 80 cases presenting as a pheochromocytoma (Berends, 2018). PPGL have the capacity to produce and release excessive amounts of catecholamines into the circulation. Uncontrolled release of catecholamines can be provoked by several mechanical and pharmacological stimuli (e.g., intubation, tumour manipulation, various drugs), which may result in acute blood pressure elevation, tachyarrhythmias and life-threatening cardiovascular events (so-called pheochromocytoma crisis). To prevent these complications, pre-treatment with antihypertensive agents is usually started prior to surgery. Administration of a-adrenergic receptor blockers is recommended as treatment of first choice. Tachycardia is treated with ß-adrenergic receptor blockers but should only be given to a patient who is already receiving an α-adrenergic receptor blocker for several days. Neglect of this basic treatment principle may result in a pheochromocytoma crisis with serious cardiovascular complications due to unopposed stimulation of α-adrenergic receptors with ensuing severe peripheral vasoconstriction (Sibal, 2006).

 

There is only one small non-randomised prospective study (n=22) comparing the effect of treatment with adrenoreceptor blocking agents prior to intravenous administration of low- osmolar CT contrast in patients with a PPGL. In this study, 11 patients received pre- treatment with an α- and/or ß-adrenergic receptor blocker, whereas 11 patients did not receive this premedication (Baid, 2009). Adverse events were not observed in any of these patients. In addition, plasma catecholamine levels within and between groups were not significantly different before and after intravenous administration of contrast medium. The absence of a change in plasma catecholamine levels after intravenous administration of nonionic contrast media in patients with PPGL was also demonstrated in a previous study (Mukherjee, 1997). Moreover, no adverse events were recorded in a retrospective study of 25 patients with PPGL receiving nonionic IV iodine-based contrast media without premedication (Bessell-Browne, 2007).

 

Based on these observations, intravenous administration of low-osmolar CT contrast is safe in patients with a PPGL without the need of prophylactic treatment with an α- or ß- adrenergic receptor blocker.

 

Patient series on intra-arterial administration of CT contrast are not available. A survey among six centres of expertise (i.e., five centres in the Netherlands plus the National Institute of Health, Bethesda, USA) demonstrated that five out of six centres would not start prophylactic treatment with an α- or ß-adrenergic receptor blocker in case of intra-arterial administration of CT contrast (personal communication).

 

There are no data on safety issues when using gadolinium-based or ultrasound contrast agents in PPGL patients.

 

Recommendations

 

There are no randomised studies evaluating the efficacy of prophylactic treatment in case of intravenous administration of radiocontrast medium in patients with PPGL. Limited data do not suggest that administration of radiocontrast medium provokes an uncontrolled release of catecholamines into the circulation or is associated with adverse events in patients with PPGL. We therefore consider intravenous administration of low-osmolar CT contrast to be safe in patients with a PPGL without the need of prophylactic treatment with an α- or ß- adrenergic receptor blocker.

 

Prophylactic treatment with an α-adrenergic receptor blocker (± ß-adrenergic receptor blocker) is not indicated before intravenous administration of iodine-based contrast media in patients with pheochromocytoma or paraganglioma.

 

There are no randomised studies or case series evaluating the efficacy of prophylactic treatment in case of intra-arterial administration of radiocontrast medium in patients with PPGL. This suggests that this route of administration is safe, which is also in agreement with the outcome of our brief survey among several centres of expertise. We therefore consider intra-arterial administration of low-osmolar CT contrast to be safe in patients with a PPGL without the need of prophylactic treatment with an α- or ß-adrenergic receptor blocker.

 

Prophylactic treatment with an α-adrenergic receptor blocker (± ß-adrenergic receptor blocker) is not indicated before intra-arterial administration of iodine-based contrast media in patients with pheochromocytoma or paraganglioma.

 

There are no data on safety issues when using gadolinium-based or ultrasound contrast agents for imaging in PPGL patients.

 

Gadolinium-based contrast agents and ultrasound contrast agents may be safely used in patients with pheochromocytoma or paraganglioma.

Onderbouwing

It has been suggested in the past that intravascular administration of contrast media in PPGL patients may provoke a hypertensive crisis (Eisenhofer, 2007). This raises the question whether treatment with α-adrenergic receptor blockers prior to administration of radiocontrast agents is required to prevent such a crisis.

A systematic review of the literature was performed to answer the following question: Which strategies are effective in preventing a hypertensive crisis in patients with pheochromocytoma?

 

P (Patients): Patients with pheochromocytoma or sympathetic paraganglioma and an indication for examination with contrast media.

I (Intervention): Contrast administration with a-blockers, b-blockers, calcium channel blockers.

C (Comparison): Contrast administration without additional preventive strategy.

O (Outcomes): Cardiovascular complications, hypertensive crisis.

 

Relevant outcome measures

The guideline development group considered cardiovascular complications as a critical outcome measure for decision making; and hypertensive crisis as an important outcome measure for decision making.

 

A priori, the working group did not define the outcome measures listed above but used the definitions used in the studies.

 

Search and select (Methods)

The databases Medline (via OVID) and Embase (via Embase.com) were searched with relevant search terms until 22-2-2021. The detailed search strategy is depicted under the tab Methods. The systematic literature search resulted in 125 hits. Studies were selected based on the following criteria five studies were initially selected based on title and abstract screening. After reading the full text, five studies were excluded (see Table of excluded studies in ‘Appendices to modules’), and no studies were included.

 

Results

No studies were included in the analysis of the literature, and therefore, no systematic literature analysis was performed.

  1. Baid SK, Lai EW, Wesley RA, Ling A, Timmers HJ, Adams KT, Kozupa A, Pacak K. Brief communication: radiographic contrast infusion and catecholamine release in patients with pheochromocytoma. Ann Intern Med. 2009; 150: 27-32.
  2. Berends AMA, Buitenwerf E, de Krijger RR, Veeger NJGM, van der Horst-Schrivers ANA, Links TP, Kerstens MN. Incidence of pheochromocytoma and sympathetic paraganglioma in the Netherlands: A nationwide study and systematic review. Eur J Intern Med. 2018; 51: 68-73.
  3. Bessell-Browne R, O’Malley ME. CT of Pheochromocytoma and paraganglioma: risk of adverse events with IV administration of nonionic contrast material. AJR Am J Roentgenol. 2007; 188: 970-974.
  4. Eisenhofer G, Rivers G, Rosas AL, Quezado Z, Manger WM, Pacak K. Adverse drug reactions in patients with pheochromocytoma: incidence, prevention and management. Drug Saf 2007; 30(11): 1031-1062.
  5. Mukherjee JJ, Peppercorn PD, Reznek RH, Patel V, Kaltsas G, Besser M, Grossman AB. Pheochromocytoma: effect of nonionic contrast medium in CT on circulating catecholamine levels. Radiology 1997; 202: 227-31.
  6. Nölting S, Bechmann N, Taieb D, Beuschlein F, Fassnacht M, Kroiss M, Eisenhofer G, Grossman A, Pacak K. Personalized management of pheochromocytoma and paraganglioma. Endocr Rev. 2022; 43: 199-239
  7. Sibal l, Jovanovic A, Agarwal SC, Peaston RT, James RA, Lennard TWJ, Bliss R, Batchelor A, Perros P. Phaeochromocytomas presenting as acute crises after beta blockade therapy. Clin Endocrinol (Oxf). 2006; 65(2): 186-190.

Autorisatiedatum en geldigheid

Laatst beoordeeld  : 28-11-2022

Laatst geautoriseerd  : 28-11-2022

Geplande herbeoordeling  :

Validity

The Radiological Society of the Netherlands (NVvR) will determine around 2027 if this guideline (per module) is still valid and applicable. If necessary, the scientific societies will form a new guideline group to revise the guideline. The validity of a guideline can be shorter than 5 years, if new scientific or healthcare structure developments arise, that could be a reason to commence revisions. The Radiological Society of the Netherlands is the owner of this guideline and thus primarily responsible for the actuality of the guideline. Other scientific societies that have participated in the guideline development share the responsibility to inform the primarily responsible scientific society about relevant developments in their field.

Initiatief en autorisatie

Initiatief:
  • Nederlandse Vereniging voor Radiologie
Geautoriseerd door:
  • Nederlandse Internisten Vereniging
  • Nederlandse Vereniging van Maag-Darm-Leverartsen
  • Nederlandse Vereniging voor Cardiologie
  • Nederlandse Vereniging voor Heelkunde
  • Nederlandse Vereniging voor Neurologie
  • Nederlandse Vereniging voor Obstetrie en Gynaecologie
  • Nederlandse Vereniging voor Radiologie
  • Nederlandse Vereniging voor Klinische Chemie en Laboratoriumgeneeskunde
  • Patiëntenfederatie Nederland
  • Nederlandse Vereniging voor Allergologie en Klinische Immunologie
  • Nederlandse Vereniging voor Endocrinologie
  • Nederlandse Vereniging voor Vaatchirurgie

Algemene gegevens

General Information

The Kennisinstituut van de Federatie Medisch Specialisten (www.kennisinstituut.nl) assisted the guideline development group. The guideline was financed by Stichting Kwaliteitsgelden Medisch Specialisten (SKMS) which is a quality fund for medical specialists in The Netherlands.

Samenstelling werkgroep

Guideline development group (GDG)

A multidisciplinary guideline development group (GDG) was formed for the development of the guideline in 2020. The GDG consisted of representatives from all relevant medical specialization fields which were using intravascular contrast administration in their field.

 

All GDG members have been officially delegated for participation in the GDG by their scientific societies. The GDG has developed a guideline in the period from June 2020 until November 2022. The GDG is responsible for the complete text of this guideline.

 

Guideline development group

  • Dekkers I.A. (Ilona), clinical epidemiologist and radiologist, Leiden University Medical Center, Leiden
  • Geenen R.W.F. (Remy), radiologist, Noordwest Ziekenhuisgroep, Alkmaar
  • Kerstens M.N. (Michiel), internist-endocrinologist, University Medical Centre Groningen
  • Krabbe J.G. (Hans), clinical chemist-endocrinologist, Medisch Spectrum Twente, Enschede
  • Rossius M.J.P. (Mariska), radiologist, Erasmus Medical Centre, Rotterdam
  • Uyttenboogaart M. (Maarten), neurologist and neuro-interventionalist, University Medical Centre Groningen
  • van de Luijtgaarden K.M. (Koen), vascular surgeon, Maasstad Ziekenhuis, Rotterdam
  • van der Molen A.J. (Aart), chair guideline development group, radiologist, Leiden University Medical Center, Leiden
  • van der Wolk S.L. (Sabine), gynaecologist-obstetrician, Haga Ziekenhuis, Den Haag
  • van de Ven A.A.J.M. (Annick), internist-allergologist-immunologist, University Medical Centre Groningen (until 1.7.2022)
  • van der Houwen, T.B. (Tim), internist-allergologist-immunologist, Amsterdam University Medical Center (from 1.7.2022)

Invited experts

  • van Maaren M.S. (Maurits), internist-allergologist-immunologist, Erasmus MC, Rotterdam

Belangenverklaringen

Conflicts of interest

The GDG members have provided written statements about (financially supported) relations with commercial companies, organisations or institutions that were related to the subject matter of the guideline. Furthermore, inquiries have been made regarding personal financial interests, interests due to personal relationships, interests related to reputation management, interest related to externally financed research and interests related to knowledge valorisation. The statements on conflict of interest can be requested from the administrative office of Kennisinstituut van de Federatie Medisch Specialisten (secretariaat@kennisinstituut.nl) and were summarised below.

 

Last name

Function

Other positions

Personal financial

interests

Personal relations

Reputation management

Externally financed

research

Knowledge valorisation

Other interests

Signed

Actions

Dekkers IA

Radiologist, LUMC

Clinical Epidemiologist

 

Member of contrast media safety committee, European Society of Urogenital Radiology (no payment)

 

Member, Gadolinium Research and Education Committee, European Society of Magnetic Resonance in Medicine, and Biology (no

payment)

No

No

No

No

No

Received consultancy fees from Guerbet, 2019-

2022

July 24th, 2020, Reaffirmed October 12th, 2022

No restrictions: received in part 3 of the guideline speaker fees, but this guideline does not mention specific medication, not of working mechanism, nor of side effects.

Geenen RWF

Radiologist, Noordwest ziekenhuisgroep

/Medisch specialisten

Noordwest

Member of contrast media safety

committee, European

Society of Urogenital

Radiology (no payment)

No

No

No

No

No

No

April 11th, 2020, Reaffirmed October 12th,

2022

No restrictions

Houwen T, van der

Internist - Immunologist - Allergologist, Amsterdam UMC, also seconded allergologist in Huid Medisch

Centrum

None

None

None

None

None

None

None

July 11th, 2022 Reaffirmed October 12th, 2022

No restrictions

Kerstens MN

Internist- endocrinologist, UMCG

Chairman Bijniernet (no payment)

No

No

No

No

No

No

July 1st, 2020, reaffirmed October 25th,

2022

No restrictions

Krabbe JG

Clinical chemist, Medisch Spectrum Twente

No

No

No

No

No

No

No

September 1st, 2020,

Reaffirmed October 13th, 2022

No restrictions

Luijtgaarden KM, van de

Vascular surgeon, Maasland Ziekenhuis

No

No

No

No

No

No

No

August 1st, 2020,

reaffirmed October 26th, 2022

No restrictions

Molen AJ, van der

Radiologist LUMC

Member of contrast media safety committee, European Society of Urogenital Radiology (no

payment)

 

Member, Gadolinium Research and Education Committee, European Society of Magnetic Resonance in Medicine, and Biology (no

payment)

No

No

No

No

No

Received consultancy fees from Guerbet, 2019-

2022

July, 24th, 2020 Reaffirmed October 12th, 2022

No restrictions: received in part 3 of the guideline speaker fees, but this guideline does not mention

Specific medication, not

of working mechanism, nor of side effects.

Rossius MJP

Radiologist Erasmus Medical Centre

Medical coordinator (no payment)

No

No

No

No

No

No

April 7th, 2020, Reaffirmed October 13th,

2022

No restrictions

Uyttenboogaart M

Neurologist and neuro- interventionalist UMCG

Advisor International Federation of Orthopaedic Manipulative Physical Therapist / Nederlandse Vereniging Manuele Therapie

No

No

Subsidy Hart Stichting for CONTRAST

(Consortium of New Treatments in Acute Stroke): WP8 Stroke logistics and Epidemiology: financing of 2 PhD students by the Hart Stichting / PPS

Allowance

Work package leader CONTRAST

(Consortium of New Treatments in Acute Stroke): WP8 Stroke logistics and Epidemiology

No

No

June 30th, 2020, reaffirmed October 26th, 2022

No restrictions: the CONTRAST

consortium wp8 is only about organisation and treatment of stroke.

Stroke is not in this guideline.

Ven AAJM, van de

Internist- allergologist- immunologist, UMCG

Education and research related to work as internist-

allergist

No

No

No

No

No

No

April 7th, 2020, Reaffirmed October 19th, 2022

No restrictions

Wolk S, van der

Gynaecologist- obstetrician, Haga Ziekenhuis

No

No

No

No

No

No

No

June 30th, 2021, reaffirmed October 25th,

2022

No restrictions

Inbreng patiëntenperspectief

Input of patient’s perspective

The guideline does not address a specific adult patient group, but a diverse set of diagnoses. Therefore, it was decided to invite a broad spectrum of patient organisations for the stakeholder consultation. The stakeholder consultation was performed at the beginning of the process for feedbacking on the framework of subjects and clinical questions addressed in the guideline, and during the commentary phase to provide feedback on the concept guideline. The list of organisations which were invited for the stakeholder consultation can be requested from the Kennisinstituut van de Federatie Medisch Specialisten (secretariaat@kennisinstituut.nl). In addition, patient information on safe use of contrast media in pregnancy and lactation was developed for Thuisarts.nl, a platform to inform patients about health and disease.

Implementatie

Implementation

During different phases of guideline development, implementation and practical enforceability of the guideline were considered. The factors that could facilitate or hinder the introduction of the guideline in clinical practice have been explicitly considered. The implementation plan can be found in the ‘Appendices to modules’. Furthermore, quality indicators were developed to enhance the implementation of the guideline. The indicators can also be found in the ‘Appendices to modules’.

Werkwijze

Methodology

AGREE

This guideline has been developed conforming to the requirements of the report of Guidelines for Medical Specialists 2.0 by the advisory committee of the Quality Counsel (www.kwaliteitskoepel.nl). This report is based on the AGREE II instrument (Appraisal of Guidelines for Research & Evaluation II) (www.agreetrust.org), a broadly accepted instrument in the international community and based on the national quality standards for guidelines: “Guidelines for guidelines” (www.zorginstituutnederland.nl).

 

Identification of subject matter

During the initial phase of the guideline development, the GDG identified the relevant subject matter for the guideline. The framework is consisted of both new matters, which were not yet addressed in part 1 and 2 of the guideline, and an update of matters that were subject to modification (for example in case of new published literature). Furthermore, a stakeholder consultation was performed, where input on the framework was requested.

 

Clinical questions and outcomes

The outcome of the stakeholder consultation was discussed with the GDG, after which definitive clinical questions were formulated. Subsequently, the GDG formulated relevant outcome measures (both beneficial and harmful effects). The GDG rated the outcome measures as critical, important and of limited importance (GRADE method). Furthermore, where applicable, the GDG defined relevant clinical differences.

 

Search and select

For clinical questions, specific search strategies were formulated, and scientific articles published in several electronic databases were searched. First, the studies that potentially had the highest quality of research were reviewed. The GDG selected literature in pairs (independently of each other) based on the title and abstract. A second selection was performed by the methodological advisor based on full text. The databases used, selection criteria and number of included articles can be found in the modules, the search strategy in the appendix.

 

Quality assessment of individual studies

Individual studies were systematically assessed, based on methodological quality criteria that were determined prior to the search. For systematic reviews, a combination of the AMSTAR checklist and PRISMA checklist was used. For RCTs the Cochrane risk of bias tool and suggestions by the CLARITY Group at McMaster University were used, and for cohort studies/observational studies the risk of bias tool by the CLARITY Group at McMaster University was used. The risk of bias tables can be found in the separate document Appendices to modules.

 

Summary of literature

The relevant research findings of all selected articles were shown in evidence tables. The evidence tables can be found in the separate document Appendices to modules. The most important findings in literature were described in literature summaries. When there were enough similarities between studies, the study data were pooled.

 

Grading quality of evidence and strength of recommendations

The strength of the conclusions of the included studies was determined using the GRADE- method. GRADE stands for Grading Recommendations Assessment, Development and Evaluation (see http://www.gradeworkinggroup.org) (Atkins, 2004). GRADE defines four levels for the quality of scientific evidence: high, moderate, low, or very low. These levels provide information about the certainty level of the literature conclusions (http://www.guidelinedevelopment.org/handbook).

 

The evidence was summarized in the literature analysis, followed by one or more conclusions, drawn from the body of evidence. The level of evidence for the conclusions can be found above the conclusions. Aspects such as expertise of GDG members, local expertise, patient preferences, costs, availability of facilities and organisation of healthcare aspects are important to consider when formulating a recommendation. These aspects are discussed in the paragraph justifications. The recommendations provide an answer to the clinical question or help to increase awareness and were based on the available scientific evidence and the most relevant justifications.

 

Appendices

Internal (meant for use by scientific society or its members) quality indicators were developed with the guideline and can be found in the separate document Appendices to modules. In most cases, indicators were not applicable. For most questions, additional scientific research on the subject is warranted. Therefore, the GDG formulated knowledge gaps to aid in future research, which can be found in the separate document Appendices to modules.

 

Commentary and authorisation phase

The concept guideline was subjected to commentaries by the involved scientific societies. The list of parties that participated in the commentary phase can be requested from the Kennisinstituut van de Federatie Medisch Specialisten (secretariaat@kennisinstituut.nl). The commentaries were collected and discussed with the GDG. The feedback was used to improve the guideline; afterwards the GDG made the guideline definitive. The final version of the guideline was offered to the involved scientific societies for authorization and was authorized.

 

Literature

Brouwers MC, Kho ME, Browman GP, et al. AGREE Next Steps Consortium. AGREE II: advancing guideline development, reporting and evaluation in health care. CMAJ. 2010; 182(18): E839-E842.

Medisch Specialistische Richtlijnen 2.0. Adviescommissie Richtlijnen van de Raad Kwaliteit, 2012. Available at: [URL].

Schünemann H, Brożek J, Guyatt G, et al. GRADE handbook for grading quality of evidence and strength of recommendations. Updated October 2013. The GRADE Working Group, 2013. Available at: [URL].

Schünemann HJ, Oxman AD, Brozek J, et al. Grading quality of evidence and strength of recommendations for diagnostic tests and strategies. BMJ. 2008;336(7653):1106- 1110. Erratum published in: BMJ 2008;336(7654).

Ontwikkeling van Medisch Specialistische Richtlijnen: stappenplan. Kennisinstituut van Medisch Specialisten, 2020.

Volgende:
Jodiumhoudend CM en Diabetes Mellitus (DM)