Adrenal TumorNCT03830593
Laparoscopic Adrenalectomy for Large Adrenal Tumors.
An observational study of Adrenal Tumor and Adrenal Adenoma, run by Samsun Liv Hospital at 2 sites in Turkey (Türkiye).
Trial summary
Laparoscopic adrenalectomy is the treatment of choice for the benign tumor of less than 6 cm. However, this is an ongoing debate that exact cut-off value of tumor size for LA. The aim of this study was to assess whether the size of the adrenal tumor affects preoperative and postoperative outcomes in patients… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Adrenal Tumor, Adrenal Adenoma
- What is being tested?
- Laparoscopic Adrenalectomy
- Type of treatment
- Surgery or procedure
- How many people
- 102 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 7 Feb 2019to 5 Jul 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From April 2010 to October 2018, preoperative and postoperative data of 107 patients who underwent laparoscopic adrenalectomy
Who may be able to join
- all hormonally active adrenal lesions,
- detection of increases in size in < 4 cm adrenal tumors on serial imaging,
- solitary adrenal metastases without evidence of local invasion,
- tumors size ≥ 4 cm,
- patients between the age of 18 and 80
- American Society of Anesthesiologists score (ASA) ≤ 3.
Who cannot join
- suspicion of malignancy on imaging such as local invasion, irregular tumor margins
- Retroperitoneoscopic adrenalectomies
- laparoscopic partial adrenalectomies
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Samsun Liv Hospital
Samsun, 55020
Ondokuz Mayıs University
Samsun, 55030
About this study
Official title: Is There Anything New in the Field of Large Adrenal Tumors ?
Laparoscopic adrenalectomy is the treatment of choice for the benign tumor of less than 6 cm. However, this is an ongoing debate that exact cut-off value of tumor size for LA. The aim of this study was to assess whether the size of the adrenal tumor affects preoperative and postoperative outcomes in patients undergoing laparoscopic transperitoneal adrenalectomy as well as to evaluate the learning curve.
Read the detailed description
From April 2010 to October 2018, preoperative and postoperative data of 107 patients who underwent LTA with adrenal mass were recorded prospectively and analyzed retrospectively.
The inclusion criteria were all hormonally active adrenal lesions, detection of increases in size in < 4 cm adrenal tumors on serial imaging, solitary adrenal metastases without evidence of local invasion, tumors size ≥ 4 cm, patients between the age of 18 and 80, and American Society of Anesthesiologists score (ASA) ≤ 3. The patients with adrenal masses that specified suspicion of malignancy on imaging such as local invasion, irregular tumor margins were evaluated as ineligible for LTA, and excluded in this study, were addressed to open surgery. Retroperitoneoscopic and laparoscopic partial adrenalectomies were also excluded from the study.
Totally 102 patients were included in the study. The patients were allocated according to adrenal tumor size as <6cm (group 1:76) and ≥ 6 cm (group 2: 26). The variables such as demographics, tumor size, and laterality, operation time, blood loss, per-operative and postoperative complications, length of hospital stay, final pathology result were compared between the two groups. In order to evaluate the learning curve, the patients were also classified into three consecutive groups including group A (1-25), group B (25-50), group C (51-75) and group D (76-102) according to the chronological order of their surgery. Variables including operation time, tumor size, blood loss, and hospital stay, and overall complications were used to investigate the learning curve.
- Conditions
- Adrenal Tumor, Adrenal Adenoma
- Being tested
- Laparoscopic Adrenalectomy
- Keywords
- endocrine surgery; laparoscopic adrenalectomy;
- Medical subject headings
- Adrenal Gland Neoplasms, ACTH Syndrome, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic AdrenalectomyProcedure or surgery
minimally invasive lateral transperitoneal adrenalectomy
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | laparoscopic adrenalectomy group 1: tumor size as < 6 (group1) Receives: Procedure: Laparoscopic Adrenalectomy | |
| Group 2 | Laparoscopic adrenalectomy group2: tumor size ≥ 6 cm (group2) Receives: Procedure: Laparoscopic Adrenalectomy | |
| Learning Curve | The patients, underwent laparoscopic adrenalectomy, were also classified into group A (1-25), B (26-50), C (51-75), and D (76-102) according to the chronological order of their surgery in order to evaluate the learning curve. Receives: Procedure: Laparoscopic Adrenalectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operation time
time from onset to complete of operation
Measured: intraoperative (minute)
Blood loss
amount of bleeding during surgery (milliliter)
Measured: intraoperative
hospitalization
duration of postoperative hospital stay
Measured: 1 day
Complication
abnormal conditions during or after surgery
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start7 Feb 2019
- Primary completion20 May 2019
- Study completion5 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun Liv Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ondokuz Mayıs University
- Responsible party
- Principal investigator, Mehmet Necmettin Mercimek, Samsun Liv Hospital
- Investigators
- Şaban Sarıkaya, Prof. MD, Study chair, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830593
- Sponsor's protocol ID
- OMU KAEK (2019/78)
- Status last verified
- Dec 2018
- First submitted
- 2 Feb 2019
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huynh KT, Lee DY, Lau BJ, Flaherty DC, Lee J, Goldfarb M. Impact of Laparoscopic Adrenalectomy on Overall Survival in Patients with Nonmetastatic Adrenocortical Carcinoma. J Am Coll Surg. 2016 Sep;223(3):485-92. doi: 10.1016/j.jamcollsurg.2016.05.015. Epub 2016 May 26.
PubMed 27238874Conzo G, Gambardella C, Candela G, Sanguinetti A, Polistena A, Clarizia G, Patrone R, Di Capua F, Offi C, Musella M, Iorio S, Bellastella G, Pasquali D, De Bellis A, Sinisi A, Avenia N. Single center experience with laparoscopic adrenalectomy on a large clinical series. BMC Surg. 2018 Jan 11;18(1):2. doi: 10.1186/s12893-017-0333-8.
PubMed 29325527
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There Anything New in the Field of Large Adrenal Tumors ?
- ClinicalTrials.gov ID
- NCT03830593
- Acronym / sponsor ID
- OMU KAEK (2019/78)
- Conditions
- Adrenal Tumor, Adrenal Adenoma
- Keywords
- endocrine surgery; laparoscopic adrenalectomy;
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Samsun Liv HospitalUniversity, hospital or other
- Collaborators
- Ondokuz Mayıs University
- Study start
- 7 Feb 2019 (actual)
- Primary completion
- 20 May 2019 (actual)
- Study completion
- 5 Jul 2019 (actual)
- First posted
- 5 Feb 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.
Laparoscopic adrenalectomy is the treatment of choice for the benign tumor of less than 6 cm. However, this is an ongoing debate that exact cut-off value of tumor size for LA. The aim of this study was to assess whether the size of the adrenal tumor affects preoperative and postoperative outcomes in patients undergoing laparoscopic transperitoneal adrenalectomy as well as to evaluate the learning curve.
Detailed description
From April 2010 to October 2018, preoperative and postoperative data of 107 patients who underwent LTA with adrenal mass were recorded prospectively and analyzed retrospectively.
The inclusion criteria were all hormonally active adrenal lesions, detection of increases in size in < 4 cm adrenal tumors on serial imaging, solitary adrenal metastases without evidence of local invasion, tumors size ≥ 4 cm, patients between the age of 18 and 80, and American Society of Anesthesiologists score (ASA) ≤ 3. The patients with adrenal masses that specified suspicion of malignancy on imaging such as local invasion, irregular tumor margins were evaluated as ineligible for LTA, and excluded in this study, were addressed to open surgery. Retroperitoneoscopic and laparoscopic partial adrenalectomies were also excluded from the study.
Totally 102 patients were included in the study. The patients were allocated according to adrenal tumor size as <6cm (group 1:76) and ≥ 6 cm (group 2: 26). The variables such as demographics, tumor size, and laterality, operation time, blood loss, per-operative and postoperative complications, length of hospital stay, final pathology result were compared between the two groups. In order to evaluate the learning curve, the patients were also classified into three consecutive groups including group A (1-25), group B (25-50), group C (51-75) and group D (76-102) according to the chronological order of their surgery. Variables including operation time, tumor size, blood loss, and hospital stay, and overall complications were used to investigate the learning curve.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Laparoscopic Adrenalectomylaparoscopic adrenalectomy group 1: tumor size as < 6 (group1) |
| Group 2 | – | Procedure: Laparoscopic AdrenalectomyLaparoscopic adrenalectomy group2: tumor size ≥ 6 cm (group2) |
| Learning Curve | – | Procedure: Laparoscopic AdrenalectomyThe patients, underwent laparoscopic adrenalectomy, were also classified into group A (1-25), B (26-50), C (51-75), and D (76-102) according to the chronological order of their surgery in order to evaluate the learning curve. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From April 2010 to October 2018, preoperative and postoperative data of 107 patients who underwent laparoscopic adrenalectomy
Key inclusion criteria (6 listed)
- all hormonally active adrenal lesions,
- detection of increases in size in < 4 cm adrenal tumors on serial imaging,
- solitary adrenal metastases without evidence of local invasion,
- tumors size ≥ 4 cm,
- patients between the age of 18 and 80
Key exclusion criteria (3 listed)
- suspicion of malignancy on imaging such as local invasion, irregular tumor margins
- Retroperitoneoscopic adrenalectomies
- laparoscopic partial adrenalectomies
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 Adrenalectomyminimally invasive lateral transperitoneal adrenalectomy | Procedure or surgery | Group 1, Group 2, Learning Curve |
Primary outcome
Operation time
Time frame: intraoperative (minute)
time from onset to complete of operation
Blood loss
Time frame: intraoperative
amount of bleeding during surgery (milliliter)
hospitalization
Time frame: 1 day
duration of postoperative hospital stay
Complication
Time frame: 1 day
abnormal conditions during or 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 10 Oct 2019.
- Background: PubMed 27238874Huynh KT, Lee DY, Lau BJ, Flaherty DC, Lee J, Goldfarb M. Impact of Laparoscopic Adrenalectomy on Overall Survival in Patients with Nonmetastatic Adrenocortical Carcinoma. J Am Coll Surg. 2016 Sep;223(3):485-92. doi: 10.1016/j.jamcollsurg.2016.05.015. Epub 2016 May 26.
- Results publication: PubMed 29325527Conzo G, Gambardella C, Candela G, Sanguinetti A, Polistena A, Clarizia G, Patrone R, Di Capua F, Offi C, Musella M, Iorio S, Bellastella G, Pasquali D, De Bellis A, Sinisi A, Avenia N. Single center experience with laparoscopic adrenalectomy on a large clinical series. BMC Surg. 2018 Jan 11;18(1):2. doi: 10.1186/s12893-017-0333-8.
- 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.
Şaban Sarıkaya, Prof. MD study chair
Ondokuz Mayıs University
2 sites 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 Adenoma, run by Samsun Liv Hospital at 2 sites in Turkey (Türkiye).
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 6 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 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
Operation time (time frame: intraoperative (minute)). The study lists 4 primary outcomes in all. 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 NCT03830593, which also lists 2 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 10 Oct 2019.