Navigated Abdominal Lymph Node Dissections (N16LND)
Primary Purpose
Image-guide Surgery, Lymph Node Metastasis
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Surgical navigation
Conventional
Sponsored by
About this trial
This is an interventional other trial for Image-guide Surgery
Eligibility Criteria
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
Sites / Locations
- Netherlands Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Navigation
Conventional
Arm Description
Patients will get the standard of care in the Netherlands with the addition of surgical navigation
Patients will get the standard of care in the Netherlands
Outcomes
Primary Outcome Measures
Number of failed procedures
Failed procedure is defined as: presence of any residual target lymph node on follow-up imaging
Secondary Outcome Measures
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,
LN success
individual LN retrieval rate
Full Information
NCT ID
NCT05867095
First Posted
November 9, 2022
Last Updated
May 17, 2023
Sponsor
The Netherlands Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT05867095
Brief Title
Navigated Abdominal Lymph Node Dissections
Acronym
N16LND
Official Title
Targeted Abdominal Lymph nodE Dissections Randomized for Surgical NavigaTion (TALENT)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 24, 2017 (Actual)
Primary Completion Date
October 14, 2021 (Actual)
Study Completion Date
October 14, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Netherlands Cancer Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Image-guide Surgery, Lymph Node Metastasis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Navigation
Arm Type
Experimental
Arm Description
Patients will get the standard of care in the Netherlands with the addition of surgical navigation
Arm Title
Conventional
Arm Type
Other
Arm Description
Patients will get the standard of care in the Netherlands
Intervention Type
Procedure
Intervention Name(s)
Surgical navigation
Intervention Description
Patients will be operated with assistance of a navigation system
Intervention Type
Procedure
Intervention Name(s)
Conventional
Intervention Description
Patients will be operated using the conventional technique
Primary Outcome Measure Information:
Title
Number of failed procedures
Description
Failed procedure is defined as: presence of any residual target lymph node on follow-up imaging
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Surgical time to remove lymph node
Description
time from having the surgical field prepared for lymph node localization to actual removal of the lymph node, overall surgical time,
Time Frame
After surgery
Title
LN success
Description
individual LN retrieval rate
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Netherlands Cancer Institute
City
Amsterdam
State/Province
North Holland
ZIP/Postal Code
1066 CX
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Navigated Abdominal Lymph Node Dissections
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