- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05867095
Navigated Abdominal Lymph Node Dissections (N16LND)
May 17, 2023 updated by: The Netherlands Cancer Institute
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
69
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Holland
-
Amsterdam, North Holland, Netherlands, 1066 CX
- Netherlands Cancer Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Scheduled for open abdominal surgery in which targeted removal of one or more pathological lymph nodes is part of the surgical plan
Exclusion Criteria:
- Metal implants in the pelvic area
- Contra-indication for contrast enhanced CT scanning
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Navigation
Patients will get the standard of care in the Netherlands with the addition of surgical navigation
|
Patients will be operated with assistance of a navigation system
|
Other: Conventional
Patients will get the standard of care in the Netherlands
|
Patients will be operated using the conventional technique
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of failed procedures
Time Frame: 3 months
|
Failed procedure is defined as: presence of any residual target lymph node on follow-up imaging
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Surgical time to remove lymph node
Time Frame: After surgery
|
time from having the surgical field prepared for lymph node localization to actual removal of the lymph node, overall surgical time,
|
After surgery
|
LN success
Time Frame: 3 months
|
individual LN retrieval rate
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 24, 2017
Primary Completion (Actual)
October 14, 2021
Study Completion (Actual)
October 14, 2021
Study Registration Dates
First Submitted
November 9, 2022
First Submitted That Met QC Criteria
May 17, 2023
First Posted (Actual)
May 19, 2023
Study Record Updates
Last Update Posted (Actual)
May 19, 2023
Last Update Submitted That Met QC Criteria
May 17, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N16LND
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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