PheochromocytomaNCT04566406
Pheochromocytoma and Hemodynamic Instability
An observational study of Pheochromocytoma and Hypertension, run by Jagiellonian University.
Trial summary
The aims of our study were to define perioperative HI during laparoscopic adrenalectomy for pheochromocytoma, assess the incidence of perioperative HI, and identify predictive factors of perioperative HI in our group of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pheochromocytoma, Hypertension, Surgery
- What is being tested?
- Laparoscopic adrenalectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Sep 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with histologically confirmed pheochromocytoma undergoing laparoscopic adrenalectomy
Who may be able to join
- patients with histologically confirmed pheochromocytoma undergoing laparoscopic adrenalectomy
Who cannot join
- bilateral tumour
- no histopathological result
- neoplastic spread
About this study
Official title: Risk Factors for Hemodynamic Instability During Laparoscopic Pheochromocytoma Resection - Single Centre Experience
The aims of our study were to define perioperative HI during laparoscopic adrenalectomy for pheochromocytoma, assess the incidence of perioperative HI, and identify predictive factors of perioperative HI in our group of patients.
Read the detailed description
The study was a retrospective observation of consecutive patients with histologically confirmed pheochromocytoma undergoing laparoscopic adrenalectomy between years 2003 and 2019.
- Conditions
- Pheochromocytoma, Hypertension, Surgery
- Being tested
- Laparoscopic adrenalectomy
- Keywords
- pheochromocytoma, laparoscopy, haemodynamics, surgery
- Medical subject headings
- Pheochromocytoma, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic adrenalectomyProcedure or surgery
Preoperative staging in all cases consisted of computed tomography or/and magnetic resonance imaging. Prior to surgery, a routine panel of laboratory tests was carried out. The catecholamines metabolites (metanephrine, normetanephrine, and methoxytyramine) were measured from 24-hour urine collection. All patients were preoperatively treated with phenoxybenzamine or alternative doxazosin.Additionally, beta-blockers in case of coexisting tachycardia were given. In the morning of the operation, preinduction blood pressure was measured. Pneumoperitoneum was achieved by insufflating CO2 gas to an intraperitoneal pressure of 12 mmHg. The operative method in our department was laparoscopic transperitoneal lateral total adrenalectomy. Intraoperatively SBP and diastolic blood pressure (DBP) were measured and recorded every 10 minutes. To treat hypertensive and hypotensive episodes, intravenous doses of urapidil, ephedrine, nitrates, MgSO4, norepinephrine, or ß-blockers were administered.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Hemodynamic Instability (n, %)
Hemodynamic instability was defined as an occurrence of both intraoperative episodes of systolic blood pressure above 160 mm Hg and vasoactive (vasodilators or vasoconstrictors) drugs administration. Patients were divided into two groups: one which met both above criteria, and another one without hemodynamic instability.
Measured: intraoperative
Secondary outcomes (2)
Number of Complications in Patients (n, %)
Data on morbidity were classified according to the Clavien-Dindo classification.
Measured: Within 30 days after surgery
Number of Cardiovascular Complications in Patients (n, %)
Cardiovascular morbidity was defined as postoperative morbidity related to the cardiovascular system: postoperative hypotensive or hypertensive episodes requiring pharmacologic treatment, need for blood transfusion, myocardial or digestive ischemia, stroke, and postoperative hospitalization in intensive care unit (ICU) for cardiac-related causes.
Measured: Within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study startJan 2003
- Primary completionDec 2019
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PheochromocytomaStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karolina Zawadzka, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566406
- Sponsor's protocol ID
- Pheochromocytoma&HI
- Status last verified
- Sep 2020
- First submitted
- 17 Sep 2020
- Last updated
- 28 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Hemodynamic Instability During Laparoscopic Pheochromocytoma Resection - Single Centre Experience
- ClinicalTrials.gov ID
- NCT04566406
- Acronym / sponsor ID
- Pheochromocytoma&HI
- Conditions
- Pheochromocytoma, Hypertension, Surgery
- Keywords
- pheochromocytoma, laparoscopy, haemodynamics, surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- Jan 2003 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 28 Sep 2020 (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.
The aims of our study were to define perioperative HI during laparoscopic adrenalectomy for pheochromocytoma, assess the incidence of perioperative HI, and identify predictive factors of perioperative HI in our group of patients.
Detailed description
The study was a retrospective observation of consecutive patients with histologically confirmed pheochromocytoma undergoing laparoscopic adrenalectomy between years 2003 and 2019.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with histologically confirmed pheochromocytoma undergoing laparoscopic adrenalectomy
Key inclusion criteria (1 listed)
- patients with histologically confirmed pheochromocytoma undergoing laparoscopic adrenalectomy
Key exclusion criteria (3 listed)
- bilateral tumour
- no histopathological result
- neoplastic spread
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 |
|---|---|---|
| Laparoscopic adrenalectomyPreoperative staging in all cases consisted of computed tomography or/and magnetic resonance imaging. Prior to surgery, a routine panel of laboratory tests was carried out. The catecholamines metabolites (metanephrine, normetanephrine, and methoxytyramine) were measured from 24-hour urine collection. All patients were preoperatively treated with phenoxybenzamine or alternative doxazosin.Additionally, beta-blockers in case of coexisting tachycardia were given. In the morning of the operation, preinduction blood pressure was measured. Pneumoperitoneum was achieved by insufflating CO2 gas to an intraperitoneal pressure of 12 mmHg. The operative method in our department was laparoscopic transperitoneal lateral total adrenalectomy. Intraoperatively SBP and diastolic blood pressure (DBP) were measured and recorded every 10 minutes. To treat hypertensive and hypotensive episodes, intravenous doses of urapidil, ephedrine, nitrates, MgSO4, norepinephrine, or ß-blockers were administered. | Procedure or surgery | – |
Primary outcome
Number of Participants with Hemodynamic Instability (n, %)
Time frame: intraoperative
Hemodynamic instability was defined as an occurrence of both intraoperative episodes of systolic blood pressure above 160 mm Hg and vasoactive (vasodilators or vasoconstrictors) drugs administration. Patients were divided into two groups: one which met both above criteria, and another one without hemodynamic instability.
2 secondary outcomes
Number of Complications in Patients (n, %)
Time frame: Within 30 days after surgery
Number of Cardiovascular Complications in Patients (n, %)
Time frame: Within 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2020.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pheochromocytoma and Hypertension, run by Jagiellonian University.
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 3 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: finished, as of the sponsor's last update on 28 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Participants with Hemodynamic Instability (n, %) (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2020.