Adrenal TumorNCT04071561
Prevention of Conversion in Posterior Retroperitoneal Adrenalectomy by Measuring Preoperative Anatomical Conditions
An observational study of Adrenal Tumor and Adrenal Mass, run by University of Basel at 1 site in Switzerland.
Trial summary
With our retrospective study the investigators show the limitations of the posterior retroperitoneal adrenalectomy by analyzing anatomical parameters. The investigators compared the data from one patient who underwent a conversion with 13 patients without a conversion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adrenal Tumor, Adrenal Mass, Pheochromocytoma
- What is being tested?
- Posterior retroperitoneal adrenalectomy (PRA) and Lateral transperitoneal adrenalectomy (LTA)
- How many people
- 14 participants
- Where
- 1 siteSwitzerland
- Study dates
- 19 Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent posterior retroperitoneal adrenalectomy at Kantonsspital Aarau.
Who may be able to join
- Patients whose adrenal gland was removed with retroperitoneal access
- Operation was between 01.07.2016 and 31.12.2018
- Operation was at the Kantonsspital Aarau
Who cannot join
- Patients with multivisceral resection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Conversion in Posterior Retroperitoneal Adrenalectomy by Measuring Preoperative Anatomical Conditions on Cross-sectional Imaging (CT or MRI)
With our retrospective study the investigators show the limitations of the posterior retroperitoneal adrenalectomy by analyzing anatomical parameters.
The investigators compared the data from one patient who underwent a conversion with 13 patients without a conversion. Furthermore, they explored the influence of these parameters on the operation time and excluded the patient who had a conversion from this analysis.
The investigators hypothesize that by determining anatomical characteristics on cross-sectional imaging (CT or MRI), they can show the limitations of the posterior retroperitoneal adrenalectomy to prevent patients from being converted to lateral transperitoneal adrenalectomy.
Read the detailed description
Minimally invasive adrenalectomy has become the gold standard for the surgical treatment of small, benign adrenal lesions. In addition to the common laparoscopic lateral transperitoneal adrenalectomy, the posterior retroperitoneal adrenalectomy is becoming increasingly important.
To date, there is no consensus regarding the preferred approach in the resection of benign adrenal tumors. A comprehensive adrenal tumor program should be able to offer both options, however, patient selection criteria for a given approach have not yet been defined. The choice between lateral transperitoneal adrenalectomy and posterior retroperitoneal adrenalectomy is relevant for patients with unilateral tumors < 6-7 cm and without previous abdominal surgery.
The aim of this study was to determine the limits of posterior retroperitoneal adrenalectomy using anatomical parameters to enable the preferred access to be chosen preoperatively to prevent conversion. In addition, the investigators describe the relationship between these parameters and the operation time to find a measure of the degree of technical difficulty.
- Conditions
- Adrenal Tumor, Adrenal Mass, Pheochromocytoma, Conn Adenoma, Adrenal Metastases, Adrenal Hyperplasia
- Being tested
- Posterior retroperitoneal adrenalectomy (PRA), Lateral transperitoneal adrenalectomy (LTA)
- Keywords
- Adrenalectomy, Minimally invasive surgery, Posterior Retroperitoneoscopic adrenalectomy, Retroperitoneal fat mass
- Medical subject headings
- Adrenal Gland Neoplasms, Pheochromocytoma, Adrenocortical Adenoma, Adrenal Hyperplasia, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior retroperitoneal adrenalectomy (PRA)Other
Minimally invasive adrenalectomy procedure
Lateral transperitoneal adrenalectomy (LTA)Other
During posterior retroperitoneal adrenalectomy, the failure to progress or the difficulty of creating or maintaining a pneumoperitoneum are reasons why conversion occurs.
| Study group | Role | What they receive |
|---|---|---|
| Non-conversion | In 13 patients, 14 posterior retroperitoneal adrenalectomy procedures were successfully completed and form the non-conversion group Receives: Other: Posterior retroperitoneal adrenalectomy (PRA) | |
| Conversion | Conversion to lateral transperitoneal adrenalectomy was necessary in 1 patient after starting posterior retroperitoneal adrenalectomy. Receives: Other: Posterior retroperitoneal adrenalectomy (PRA); Other: Lateral transperitoneal adrenalectomy (LTA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sagittal distance between the dorsal border of the adrenal gland and the 12th rib tip
Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Sagittal distance between the dorsal border of the adrenal gland and the 12th rib tip, mm.
Measured: The measurement was performed in the period from 19.11.2018 - 04.02.2019.
Thickness of retroperitoneal fat
Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Defined as the largest distance between the kidney parenchyma and the posterior abdominal wall at the level where the renal vein joins the vena cava inferior.
Measured: The measurement was performed in the period from 19.11.2018 - 04.02.2019.
Posterior Adiposity Index
Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Distance from skin to renal parenchyma through the 12th rib tip. The larger the distance, the larger the index. The scale ranges are open.
Measured: The measurement of the parameter from the cross-sectional image was performed in the period from 19.11.2018 - 04.02.2019.
Longitudinal distance between the upper pole of the kidney and the inferior border of the adrenal gland.
Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Longitudinal distance between the upper pole of the kidney and the inferior border of the adrenal gland, mm.
Measured: The measurement was performed in the period from 19.11.2018 - 04.02.2019.
Longitudinal distance between the superior border of the adrenal gland to the 12th rib tip.
Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Longitudinal distance between the superior border of the adrenal gland to the 12th rib tip, mm.
Measured: The measurement was performed in the period from 19.11.2018 - 04.02.2019.
Longitudinal distance between the 12th rib and the iliac crest
Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Longitudinal distance between the 12th rib and the iliac crest, mm.
Measured: The measurement was performed in the period from 19.11.2018 - 04.02.2019.
Sagittal thickness of the subcutaneous layer above the 12th rib tip
Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Sagittal thickness of the subcutaneous layer above the 12th rib tip, mm.
Measured: The measurement was performed in the period from 19.11.2018 - 04.02.2019.
Sagittal thickness of the subcutaneous layer above the iliac crest
Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Sagittal thickness of the subcutaneous layer above the iliac crest, mm.
Measured: The measurement was performed in the period from 19.11.2018 - 04.02.2019.
Thickness of the subcutaneous layer above the 12th rib tip
Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Thickness of the subcutaneous layer above the 12th rib tip, measured on the straight line to the center of gravity, mm.
Measured: The measurement was performed in the period from 19.11.2018 - 04.02.2019.
Sagittal thickness of the subcutaneous layer between the center of gravity and the lateral border of the body
Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Sagittal thickness of the subcutaneous layer between the center of gravity and the lateral border of the body, measured at the level of the 12th rib tip, mm.
Measured: The measurement was performed in the period from 19.11.2018 - 04.02.2019.
Tumor size
Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Tumor size, cm.
Measured: The measurement was performed in the period from 19.11.2018 - 04.02.2019.
Operative time
Duration of adrenalectomy. Data were extracted and analyzed from the hospital information system.
Measured: The data were collected between 19.11.2018 and 04.02.2019.
Secondary outcomes (7)
Body-Mass-Index
Value derived from the mass (weight) and height of a person. Data were extracted and analyzed from the hospital information system.
Measured: The data were collected between 19.11.2018 and 04.02.2019.
The side of the adrenal gland that was removed
Side of the removed adrenal gland (left, right, bilateral). Data were extracted and analyzed from the hospital information system.
Measured: The data were collected between 19.11.2018 and 04.02.2019.
Previously performed abdominal surgeries taken from the hospital information system
Previous abdominal operations with opening of the abdominal cavity which give an indication of adhesions.Data were extracted and analyzed from the hospital information system.
Measured: The data were collected between 19.11.2018 and 04.02.2019.
Age
Age at adrenalectomy. Data were extracted and analyzed from the hospital information system.
Measured: The data were collected between 19.11.2018 and 04.02.2019.
Sex
Female or Male
Measured: The data were collected between 19.11.2018 and 04.02.2019.
Histological diagnosis of the sample from the adrenalectomy
Histological evaluation. Data were extracted and analyzed from the hospital information system.
Measured: The data were collected between 19.11.2018 and 04.02.2019.
Imaging
CT or MRI
Measured: The data were collected between 19.11.2018 and 04.02.2019.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start19 Nov 2018
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenal TumorStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Basel
- Sponsor type
- University, hospital or other
- Collaborators
- Kantonsspital Aarau
- Responsible party
- Principal investigator, Simone Eichelberger, University of Basel
- Investigators
- Christian A Nebiker, PD Dr. med., Principal investigator, Kantonsspital Aarau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04071561
- Sponsor's protocol ID
- 201901147
- Status last verified
- Aug 2019
- First submitted
- 22 Aug 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Conversion in Posterior Retroperitoneal Adrenalectomy by Measuring Preoperative Anatomical Conditions on Cross-sectional Imaging (CT or MRI)
- ClinicalTrials.gov ID
- NCT04071561
- Acronym / sponsor ID
- 201901147
- Conditions
- Adrenal Tumor, Adrenal Mass, Pheochromocytoma, Conn Adenoma, Adrenal Metastases, Adrenal Hyperplasia
- Keywords
- Adrenalectomy, Minimally invasive surgery, Posterior Retroperitoneoscopic adrenalectomy, Retroperitoneal fat mass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of BaselUniversity, hospital or other
- Collaborators
- Kantonsspital Aarau
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 28 Aug 2019 (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.
With our retrospective study the investigators show the limitations of the posterior retroperitoneal adrenalectomy by analyzing anatomical parameters.
The investigators compared the data from one patient who underwent a conversion with 13 patients without a conversion. Furthermore, they explored the influence of these parameters on the operation time and excluded the patient who had a conversion from this analysis.
The investigators hypothesize that by determining anatomical characteristics on cross-sectional imaging (CT or MRI), they can show the limitations of the posterior retroperitoneal adrenalectomy to prevent patients from being converted to lateral transperitoneal adrenalectomy.
Detailed description
Minimally invasive adrenalectomy has become the gold standard for the surgical treatment of small, benign adrenal lesions. In addition to the common laparoscopic lateral transperitoneal adrenalectomy, the posterior retroperitoneal adrenalectomy is becoming increasingly important.
To date, there is no consensus regarding the preferred approach in the resection of benign adrenal tumors. A comprehensive adrenal tumor program should be able to offer both options, however, patient selection criteria for a given approach have not yet been defined. The choice between lateral transperitoneal adrenalectomy and posterior retroperitoneal adrenalectomy is relevant for patients with unilateral tumors < 6-7 cm and without previous abdominal surgery.
The aim of this study was to determine the limits of posterior retroperitoneal adrenalectomy using anatomical parameters to enable the preferred access to be chosen preoperatively to prevent conversion. In addition, the investigators describe the relationship between these parameters and the operation time to find a measure of the degree of technical difficulty.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-conversion | – | Other: Posterior retroperitoneal adrenalectomy (PRA)In 13 patients, 14 posterior retroperitoneal adrenalectomy procedures were successfully completed and form the non-conversion group |
| Conversion | – | Other: Posterior retroperitoneal adrenalectomy (PRA), Other: Lateral transperitoneal adrenalectomy (LTA)Conversion to lateral transperitoneal adrenalectomy was necessary in 1 patient after starting posterior retroperitoneal adrenalectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent posterior retroperitoneal adrenalectomy at Kantonsspital Aarau.
Key inclusion criteria (3 listed)
- Patients whose adrenal gland was removed with retroperitoneal access
- Operation was between 01.07.2016 and 31.12.2018
- Operation was at the Kantonsspital Aarau
Key exclusion criteria (1 listed)
- Patients with multivisceral resection
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 |
|---|---|---|
| Posterior retroperitoneal adrenalectomy (PRA)Minimally invasive adrenalectomy procedure | Other | Conversion, Non-conversion |
| Lateral transperitoneal adrenalectomy (LTA)During posterior retroperitoneal adrenalectomy, the failure to progress or the difficulty of creating or maintaining a pneumoperitoneum are reasons why conversion occurs. | Other | Conversion |
Primary outcome
Sagittal distance between the dorsal border of the adrenal gland and the 12th rib tip
Time frame: The measurement was performed in the period from 19.11.2018 - 04.02.2019.
Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Sagittal distance between the dorsal border of the adrenal gland and the 12th rib tip, mm.
Thickness of retroperitoneal fat
Time frame: The measurement was performed in the period from 19.11.2018 - 04.02.2019.
Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Defined as the largest distance between the kidney parenchyma and the posterior abdominal wall at the level where the renal vein joins the vena cava inferior.
Posterior Adiposity Index
Time frame: The measurement of the parameter from the cross-sectional image was performed in the period from 19.11.2018 - 04.02.2019.
Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Distance from skin to renal parenchyma through the 12th rib tip. The larger the distance, the larger the index. The scale ranges are open.
Longitudinal distance between the upper pole of the kidney and the inferior border of the adrenal gland.
Time frame: The measurement was performed in the period from 19.11.2018 - 04.02.2019.
Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Longitudinal distance between the upper pole of the kidney and the inferior border of the adrenal gland, mm.
Longitudinal distance between the superior border of the adrenal gland to the 12th rib tip.
Time frame: The measurement was performed in the period from 19.11.2018 - 04.02.2019.
Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Longitudinal distance between the superior border of the adrenal gland to the 12th rib tip, mm.
Longitudinal distance between the 12th rib and the iliac crest
Time frame: The measurement was performed in the period from 19.11.2018 - 04.02.2019.
Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Longitudinal distance between the 12th rib and the iliac crest, mm.
Sagittal thickness of the subcutaneous layer above the 12th rib tip
Time frame: The measurement was performed in the period from 19.11.2018 - 04.02.2019.
Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Sagittal thickness of the subcutaneous layer above the 12th rib tip, mm.
Sagittal thickness of the subcutaneous layer above the iliac crest
Time frame: The measurement was performed in the period from 19.11.2018 - 04.02.2019.
Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Sagittal thickness of the subcutaneous layer above the iliac crest, mm.
Thickness of the subcutaneous layer above the 12th rib tip
Time frame: The measurement was performed in the period from 19.11.2018 - 04.02.2019.
Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Thickness of the subcutaneous layer above the 12th rib tip, measured on the straight line to the center of gravity, mm.
Sagittal thickness of the subcutaneous layer between the center of gravity and the lateral border of the body
Time frame: The measurement was performed in the period from 19.11.2018 - 04.02.2019.
Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Sagittal thickness of the subcutaneous layer between the center of gravity and the lateral border of the body, measured at the level of the 12th rib tip, mm.
Tumor size
Time frame: The measurement was performed in the period from 19.11.2018 - 04.02.2019.
Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Tumor size, cm.
Operative time
Time frame: The data were collected between 19.11.2018 and 04.02.2019.
Duration of adrenalectomy. Data were extracted and analyzed from the hospital information system.
7 secondary outcomes
Body-Mass-Index
Time frame: The data were collected between 19.11.2018 and 04.02.2019.
The side of the adrenal gland that was removed
Time frame: The data were collected between 19.11.2018 and 04.02.2019.
Previously performed abdominal surgeries taken from the hospital information system
Time frame: The data were collected between 19.11.2018 and 04.02.2019.
Age
Time frame: The data were collected between 19.11.2018 and 04.02.2019.
Sex
Time frame: The data were collected between 19.11.2018 and 04.02.2019.
Histological diagnosis of the sample from the adrenalectomy
Time frame: The data were collected between 19.11.2018 and 04.02.2019.
Imaging
Time frame: The data were collected between 19.11.2018 and 04.02.2019.
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 Aug 2019.
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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.
Christian A Nebiker, PD Dr. med. principal investigator
Kantonsspital Aarau
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 Adrenal Tumor and Adrenal Mass, run by University of Basel 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 3 inclusion and 1 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 Aug 2019. 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?
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?
Sagittal distance between the dorsal border of the adrenal gland and the 12th rib tip (time frame: The measurement was performed in the period from 19.11.2018 - 04.02.2019.). The study lists 12 primary outcomes in all. 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 Aug 2019.