adrenalDiseaseNCT06064370
Side-specific Factors for Intraoperative Hemodynamic Instability in Pheochromocytoma
An observational study of adrenalDisease, run by Zagazig University.
Trial summary
The performance of adrenalectomy for pheochromocytoma (PHEO) presents significant challenges due to the presence of elevated intraoperative hemodynamic instability (HI) and conversion risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- adrenalDisease
- What is being tested?
- laparoscopic adrenalectomy
- Type of treatment
- Surgery or procedure
- How many people
- 171 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 1 Sep 2023
- 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: A total of 271 patients (n = 271) were involved in the study and subsequently separated into two groups: LRA (n = 122) and LLA (n = 149).
Who may be able to join
- patients >18 years, both sex with unilateral PHEO of any size who underwent TLA
Who cannot join
- Patients who have undergone initial open adrenalectomy, various surgical procedures during total laparoscopic adrenalectomy (TLA), complete adrenalectomy,
- bilateral PHEOS bleeding diathesis, skeletal deformity, pregnancy, previous homolateral abdominal surgery, missing data, questionable preoperative diagnosis, inherited PHEO, or recurrent PHEO.
About this study
Official title: Side-specific Factors for Intraoperative Hemodynamic Instability in Adrenalectomy for Pheochromocytoma. A Comparative Analysis
The performance of adrenalectomy for pheochromocytoma (PHEO) presents significant challenges due to the presence of elevated intraoperative hemodynamic instability (HI) and conversion risk. The objective of this study was to conduct a comparative analysis of the occurrence and determinants of perioperative hypotension (HI) and conversion in left-sided (LLA) and right-sided (RLA) transabdominal laparoscopic adrenalectomy (TLA).
Read the detailed description
Pheochromocytoma (PHEO) is a malignancy characterized by the production of catecholamines from chromaffin cells located in the adrenomedullary system. The prevalence of PHEO in the general population ranges from 0.05% to 0.1%, however it is more prevalent among those with hypertension. The clinical presentation exhibits a spectrum that spans from asymptomatic to abrupt mortality. Minimally invasive laparoscopic adrenalectomy (LA) has emerged as a prominent technique in adrenal illness surgery due to its reduced surgical morbidity and death rates, making it the favored method in this field. The initial exploration of transperitoneal laparoscopic adrenalectomy (TLA) was conducted by Gagner et al. The LA procedure encompasses many transabdominal and retroperitoneal techniques, whereas TLA is favored by surgeons due to its well-known anatomy and expansive working area. Nevertheless, PHEO surgery remains a formidable task for surgeons and anesthesiologists due to its established correlation with hemodynamic instability (HI), resulting in symptoms such as abrupt hypertension or tachycardia, as well as severe and protracted hypotension following tumor excision. Skilled surgeons and anesthesiologists enhance the outcomes and reduce the occurrence of hypotension. The research has documented a multitude of additional risk factors associated with HI. The observed variability could perhaps be attributed to the lack of consistent anesthesiological and surgical protocols, as well as variations in the definitions of HI. Laparoscopic adrenalectomy does not have any absolute contraindications. However, it is worth noting that up to 20% of patients may need to undergo conversion to an open procedure. There has been no specific evaluation of the incidence and risk factors of perioperative hypotension (both intraoperative and postoperative) and conversion rate in a large group of patients undergoing laparoscopic right adrenalectomy (LRA) or laparoscopic left adrenalectomy (LLA) for managing pheochromocytoma resection.
- Conditions
- adrenalDisease
- Being tested
- laparoscopic adrenalectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic adrenalectomyProcedure or surgery
laparoscopic adrenalectomy for pheochromocytoma
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic right adrenalectomy | laparoscopic right adrenalectomy for pheochromocytoma Receives: Procedure: laparoscopic adrenalectomy | |
| laparoscopic left adrenalectomy | laparoscopic left adrenalectomy for pheochromocytoma Receives: Procedure: laparoscopic adrenalectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemodynamic instability
incidence of hemodynamic instability
Measured: intraoperative and immediate postoperative
Secondary outcomes (1)
conversion rate
incidence of conversion
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start1 Sep 2016
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for adrenalDiseaseStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tamer.A.A.M.Habeeb, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064370
- Sponsor's protocol ID
- adrenalectomy
- Status last verified
- Jun 2024
- First submitted
- 26 Sep 2023
- Last updated
- 11 Jun 2024
- 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 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Side-specific Factors for Intraoperative Hemodynamic Instability in Adrenalectomy for Pheochromocytoma. A Comparative Analysis
- ClinicalTrials.gov ID
- NCT06064370
- Acronym / sponsor ID
- adrenalectomy
- Conditions
- adrenalDisease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 3 Oct 2023 (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 performance of adrenalectomy for pheochromocytoma (PHEO) presents significant challenges due to the presence of elevated intraoperative hemodynamic instability (HI) and conversion risk. The objective of this study was to conduct a comparative analysis of the occurrence and determinants of perioperative hypotension (HI) and conversion in left-sided (LLA) and right-sided (RLA) transabdominal laparoscopic adrenalectomy (TLA).
Detailed description
Pheochromocytoma (PHEO) is a malignancy characterized by the production of catecholamines from chromaffin cells located in the adrenomedullary system. The prevalence of PHEO in the general population ranges from 0.05% to 0.1%, however it is more prevalent among those with hypertension. The clinical presentation exhibits a spectrum that spans from asymptomatic to abrupt mortality. Minimally invasive laparoscopic adrenalectomy (LA) has emerged as a prominent technique in adrenal illness surgery due to its reduced surgical morbidity and death rates, making it the favored method in this field. The initial exploration of transperitoneal laparoscopic adrenalectomy (TLA) was conducted by Gagner et al. The LA procedure encompasses many transabdominal and retroperitoneal techniques, whereas TLA is favored by surgeons due to its well-known anatomy and expansive working area. Nevertheless, PHEO surgery remains a formidable task for surgeons and anesthesiologists due to its established correlation with hemodynamic instability (HI), resulting in symptoms such as abrupt hypertension or tachycardia, as well as severe and protracted hypotension following tumor excision. Skilled surgeons and anesthesiologists enhance the outcomes and reduce the occurrence of hypotension. The research has documented a multitude of additional risk factors associated with HI. The observed variability could perhaps be attributed to the lack of consistent anesthesiological and surgical protocols, as well as variations in the definitions of HI. Laparoscopic adrenalectomy does not have any absolute contraindications. However, it is worth noting that up to 20% of patients may need to undergo conversion to an open procedure. There has been no specific evaluation of the incidence and risk factors of perioperative hypotension (both intraoperative and postoperative) and conversion rate in a large group of patients undergoing laparoscopic right adrenalectomy (LRA) or laparoscopic left adrenalectomy (LLA) for managing pheochromocytoma resection.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic right adrenalectomy | – | Procedure: laparoscopic adrenalectomylaparoscopic right adrenalectomy for pheochromocytoma |
| laparoscopic left adrenalectomy | – | Procedure: laparoscopic adrenalectomylaparoscopic left adrenalectomy for pheochromocytoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 271 patients (n = 271) were involved in the study and subsequently separated into two groups: LRA (n = 122) and LLA (n = 149).
Key inclusion criteria (1 listed)
- patients >18 years, both sex with unilateral PHEO of any size who underwent TLA
Key exclusion criteria (2 listed)
- Patients who have undergone initial open adrenalectomy, various surgical procedures during total laparoscopic adrenalectomy (TLA), complete adrenalectomy,
- bilateral PHEOS bleeding diathesis, skeletal deformity, pregnancy, previous homolateral abdominal surgery, missing data, questionable preoperative diagnosis, inherited PHEO, or recurrent PHEO.
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 adrenalectomylaparoscopic adrenalectomy for pheochromocytoma | Procedure or surgery | laparoscopic left adrenalectomy, laparoscopic right adrenalectomy |
Primary outcome
hemodynamic instability
Time frame: intraoperative and immediate postoperative
incidence of hemodynamic instability
1 secondary outcome
conversion rate
Time frame: intraoperative
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 11 Jun 2024.
- Individual participant dataSharing planned: No
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 adrenalDisease, run by Zagazig 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 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: finished, as of the sponsor's last update on 11 Jun 2024. 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?
hemodynamic instability (time frame: intraoperative and immediate postoperative). 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 11 Jun 2024.