Image-guide SurgeryN16LNDNCT05867095
Navigated Abdominal Lymph Node Dissections
A study testing Surgical navigation and Conventional in people with Image-guide Surgery and Lymph Node Metastasis, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
Image-guided navigation surgery allows for full utilization of pre-operative imaging during surgery, and has the potential of reducing both irradical resections and morbidity. In this study we will randomize patients which will undergo an abdominal lymph node dissection in order to evaluate the actual technical and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Image-guide Surgery, Lymph Node Metastasis
- What is being tested?
- Surgical navigation and Conventional
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteNetherlands
- Study dates
- 24 Jan 2017to 14 Oct 2021
- Phase
- Interventional
- 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
Who may be able to join
- Scheduled for open abdominal surgery in which targeted removal of one or more pathological lymph nodes is part of the surgical plan
Who cannot join
- Metal implants in the pelvic area
- Contra-indication for contrast enhanced CT scanning
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Netherlands Cancer Institute
Amsterdam, North Holland, 1066 CX
About this study
Official title: Targeted Abdominal Lymph nodE Dissections Randomized for Surgical NavigaTion (TALENT)
Image-guided navigation surgery allows for full utilization of pre-operative imaging during surgery, and has the potential of reducing both irradical resections and morbidity. In this study we will randomize patients which will undergo an abdominal lymph node dissection in order to evaluate the actual technical and clinical benefit of navigation
Read the detailed description
In the study patients will be randomized between the use of a surgical navigation system or not. The operation itself will be performed according to current clinical practice, and the navigation system will be used for better localization and orientation during the procedure.
- Conditions
- Image-guide Surgery, Lymph Node Metastasis
- Being tested
- Surgical navigation, Conventional
- Medical subject headings
- Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical navigationProcedure or surgery
Patients will be operated with assistance of a navigation system
ConventionalProcedure or surgery
Patients will be operated using the conventional technique
| Study group | Role | What they receive |
|---|---|---|
| Navigation | Experimental | Patients will get the standard of care in the Netherlands with the addition of surgical navigation Receives: Procedure: Surgical navigation |
| Conventional | Other | Patients will get the standard of care in the Netherlands Receives: Procedure: Conventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of failed procedures
Failed procedure is defined as: presence of any residual target lymph node on follow-up imaging
Measured: 3 months
Secondary outcomes (2)
Surgical time to remove lymph node
time from having the surgical field prepared for lymph node localization to actual removal of the lymph node, overall surgical time,
Measured: After surgery
LN success
individual LN retrieval rate
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start24 Jan 2017
- Primary completion14 Oct 2021
- Study completion14 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Image-guide SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867095
- Sponsor's protocol ID
- N16LND
- Acronym
- N16LND
- Status last verified
- May 2023
- First submitted
- 9 Nov 2022
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Groen HC, Wit EMK, Heerink WJ, Kuhlmann KFD, Nijkamp JA, van Veen R, Schoots IG, Balduzzi S, Zijlmans HJMAA, van Leeuwen PJ, van der Poel HG, Ruers TJM. Surgical navigation for targeted retroperitoneal lymph-node removal: a randomised, controlled, phase 3 trial. EClinicalMedicine. 2024 Jul 26;74:102754. doi: 10.1016/j.eclinm.2024.102754. eCollection 2024 Aug.
PubMed 39737148
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Abdominal Lymph nodE Dissections Randomized for Surgical NavigaTion (TALENT)
- ClinicalTrials.gov ID
- NCT05867095
- Acronym / sponsor ID
- N16LND / N16LND
- Conditions
- Image-guide Surgery, Lymph Node Metastasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 24 Jan 2017 (actual)
- Primary completion
- 14 Oct 2021 (actual)
- Study completion
- 14 Oct 2021 (actual)
- First posted
- 19 May 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.
Image-guided navigation surgery allows for full utilization of pre-operative imaging during surgery, and has the potential of reducing both irradical resections and morbidity. In this study we will randomize patients which will undergo an abdominal lymph node dissection in order to evaluate the actual technical and clinical benefit of navigation
Detailed description
In the study patients will be randomized between the use of a surgical navigation system or not. The operation itself will be performed according to current clinical practice, and the navigation system will be used for better localization and orientation during the procedure.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Navigation | Experimental | Procedure: Surgical navigationPatients will get the standard of care in the Netherlands with the addition of surgical navigation |
| Conventional | Other | Procedure: ConventionalPatients will get the standard of care in the Netherlands |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled for open abdominal surgery in which targeted removal of one or more pathological lymph nodes is part of the surgical plan
Key exclusion criteria (2 listed)
- Metal implants in the pelvic area
- Contra-indication for contrast enhanced CT scanning
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 |
|---|---|---|
| Surgical navigationPatients will be operated with assistance of a navigation system | Procedure or surgery | Navigation |
| ConventionalPatients will be operated using the conventional technique | Procedure or surgery | Conventional |
Primary outcome
Number of failed procedures
Time frame: 3 months
Failed procedure is defined as: presence of any residual target lymph node on follow-up imaging
2 secondary outcomes
Surgical time to remove lymph node
Time frame: After surgery
LN success
Time frame: 3 months
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 19 May 2023.
- Derived from this study: PubMed 39737148Groen HC, Wit EMK, Heerink WJ, Kuhlmann KFD, Nijkamp JA, van Veen R, Schoots IG, Balduzzi S, Zijlmans HJMAA, van Leeuwen PJ, van der Poel HG, Ruers TJM. Surgical navigation for targeted retroperitoneal lymph-node removal: a randomised, controlled, phase 3 trial. EClinicalMedicine. 2024 Jul 26;74:102754. doi: 10.1016/j.eclinm.2024.102754. eCollection 2024 Aug.
- Individual participant dataSharing planned: No
Related trials for Image-guide Surgery
RecruitingPhase 1
The Use of Nanoparticles to Guide the Surgical Treatment of Prostate Cancer
Prostate Cancer
Recruiting
Evaluation of the Clinical and Cost-effectiveness of an Automated Mobile Hybrid Room in Vascular Surgery Compared with Current Practice
Endovascular
Recruiting
GPC3 Targeted Fluorescence Image Guided Surgery of Hepatocellular Carcinoma
Hepatocellular Carcinoma
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?
A study testing Surgical navigation and Conventional in people with Image-guide Surgery and Lymph Node Metastasis, run by The Netherlands Cancer Institute at 1 site in Netherlands.
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 19 May 2023. 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 Netherlands. 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?
Number of failed procedures (time frame: 3 months). 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 NCT05867095, which also lists 1 linked publication.
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 19 May 2023.