RetinoblastomaNCT03559894
Severe and Transient Hypoxemia During Selective Intra-arterial Chemotherapy for Retinoblastoma in Children: Evaluation of the Right-sided Heart Function.
An observational study of Retinoblastoma, run by Christian Kern at 1 site in Switzerland.
Trial summary
Children having selective ophthalmic artery chemotherapy for retinoblastoma under general anaesthesia may experience troubles during the procedure. The troubles are transient, may be severe and include hypoxemia, hypotension and bradycardia. Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Retinoblastoma
- What is being tested?
- Trans-thoracic echocardiography
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2018to 31 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: All children 0 to 6 years old having selective ophthalmic artery chemotherapy for retinoblastoma under general anaesthesia are eligible.
Who may be able to join
- Retinoblastoma requiring selective ophthalmic artery chemotherapy under general anaesthesia
Who cannot join
- Obesity
- pre-existing significant heart or pulmonary disease.
Trial locations and contacts
1 site in 1 country.
About this study
Children having selective ophthalmic artery chemotherapy for retinoblastoma under general anaesthesia may experience troubles during the procedure. The troubles are transient, may be severe and include hypoxemia, hypotension and bradycardia. All children having such trouble always fully recovered without any sequelae or prolonged length of stay. The investigators suspect that these phenomenons are caused by transient pulmonary hypertension.The objective is to see whether transient pulmonary hypertension and right-sided heart failure is present during theses phenomenon by trans-thoracic echocardiography.
- Conditions
- Retinoblastoma
- Being tested
- Trans-thoracic echocardiography
- Medical subject headings
- Retinoblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-thoracic echocardiographyDiagnostic test
Trans-thoracic echocardiography
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of pulmonary hypertension and/or right-sided heart failure (systolic arterial pulmonary pressure and visual function of the right ventricle is measured)
Measured: Perioperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start1 Jan 2018
- Primary completion31 May 2019 (estimated)
- Study completion31 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for RetinoblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christian Kern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christian Kern, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559894
- Sponsor's protocol ID
- 2017-01539
- Other IDs
- 2017
- Status last verified
- Jun 2018
- First submitted
- 19 Oct 2017
- Last updated
- 18 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Phillips TJ, McGuirk SP, Chahal HK, Kingston J, Robertson F, Brew S, Roebuck D, Hungerford JL, Herod J. Autonomic cardio-respiratory reflex reactions and superselective ophthalmic arterial chemotherapy for retinoblastoma. Paediatr Anaesth. 2013 Oct;23(10):940-5. doi: 10.1111/pan.12162. Epub 2013 May 13.
PubMed 23668238Kato MA, Green N, O'Connell K, Till SD, Kramer DJ, Al-Khelaifi M, Han JH, Pryor KO, Gobin YP, Proekt A. A retrospective analysis of severe intraoperative respiratory compliance changes during ophthalmic arterial chemosurgery for retinoblastoma. Paediatr Anaesth. 2015 Jun;25(6):595-602. doi: 10.1111/pan.12603. Epub 2015 Jan 7.
PubMed 25565164Scharoun JH, Han JH, Gobin YP. Anesthesia for Ophthalmic Artery Chemosurgery. Anesthesiology. 2017 Jan;126(1):165-172. doi: 10.1097/ALN.0000000000001381. No abstract available.
PubMed 27748655Monroy JE, Orbach DB, VanderVeen D. Complications of intra-arterial chemotherapy for retinoblastoma. Semin Ophthalmol. 2014 Sep-Nov;29(5-6):429-33. doi: 10.3109/08820538.2014.959188.
PubMed 25325870Schaller B, Cornelius JF, Prabhakar H, Koerbel A, Gnanalingham K, Sandu N, Ottaviani G, Filis A, Buchfelder M; Trigemino-Cardiac Reflex Examination Group (TCREG). The trigemino-cardiac reflex: an update of the current knowledge. J Neurosurg Anesthesiol. 2009 Jul;21(3):187-95. doi: 10.1097/ANA.0b013e3181a2bf22.
PubMed 19542994
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severe and Transient Hypoxemia During Selective Intra-arterial Chemotherapy for Retinoblastoma in Children: Evaluation of the Right-sided Heart Function.
- ClinicalTrials.gov ID
- NCT03559894
- Acronym / sponsor ID
- 2017-01539
- Conditions
- Retinoblastoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Christian KernUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 May 2019 (estimated)
- Study completion
- 31 May 2019 (estimated)
- First posted
- 18 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Children having selective ophthalmic artery chemotherapy for retinoblastoma under general anaesthesia may experience troubles during the procedure. The troubles are transient, may be severe and include hypoxemia, hypotension and bradycardia. All children having such trouble always fully recovered without any sequelae or prolonged length of stay. The investigators suspect that these phenomenons are caused by transient pulmonary hypertension.The objective is to see whether transient pulmonary hypertension and right-sided heart failure is present during theses phenomenon by trans-thoracic echocardiography.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All children 0 to 6 years old having selective ophthalmic artery chemotherapy for retinoblastoma under general anaesthesia are eligible.
Key inclusion criteria (1 listed)
- Retinoblastoma requiring selective ophthalmic artery chemotherapy under general anaesthesia
Key exclusion criteria (2 listed)
- Obesity
- pre-existing significant heart or pulmonary disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trans-thoracic echocardiographyTrans-thoracic echocardiography | Diagnostic test | – |
Primary outcome
Identification of pulmonary hypertension and/or right-sided heart failure (systolic arterial pulmonary pressure and visual function of the right ventricle is measured)
Time frame: Perioperative.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2018.
- Results publication: PubMed 23668238Phillips TJ, McGuirk SP, Chahal HK, Kingston J, Robertson F, Brew S, Roebuck D, Hungerford JL, Herod J. Autonomic cardio-respiratory reflex reactions and superselective ophthalmic arterial chemotherapy for retinoblastoma. Paediatr Anaesth. 2013 Oct;23(10):940-5. doi: 10.1111/pan.12162. Epub 2013 May 13.
- Results publication: PubMed 25565164Kato MA, Green N, O'Connell K, Till SD, Kramer DJ, Al-Khelaifi M, Han JH, Pryor KO, Gobin YP, Proekt A. A retrospective analysis of severe intraoperative respiratory compliance changes during ophthalmic arterial chemosurgery for retinoblastoma. Paediatr Anaesth. 2015 Jun;25(6):595-602. doi: 10.1111/pan.12603. Epub 2015 Jan 7.
- Results publication: PubMed 27748655Scharoun JH, Han JH, Gobin YP. Anesthesia for Ophthalmic Artery Chemosurgery. Anesthesiology. 2017 Jan;126(1):165-172. doi: 10.1097/ALN.0000000000001381. No abstract available.
- Results publication: PubMed 25325870Monroy JE, Orbach DB, VanderVeen D. Complications of intra-arterial chemotherapy for retinoblastoma. Semin Ophthalmol. 2014 Sep-Nov;29(5-6):429-33. doi: 10.3109/08820538.2014.959188.
- Results publication: PubMed 19542994Schaller B, Cornelius JF, Prabhakar H, Koerbel A, Gnanalingham K, Sandu N, Ottaviani G, Filis A, Buchfelder M; Trigemino-Cardiac Reflex Examination Group (TCREG). The trigemino-cardiac reflex: an update of the current knowledge. J Neurosurg Anesthesiol. 2009 Jul;21(3):187-95. doi: 10.1097/ANA.0b013e3181a2bf22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinoblastoma, run by Christian Kern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of pulmonary hypertension and/or right-sided heart failure (systolic arterial pulmonary pressure and visual function of the right ventricle is measured) (time frame: Perioperative.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03559894, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2018.