Navigated Abdominal Lymph Node Dissections
N16LND
Targeted Abdominal Lymph nodE Dissections Randomized for Surgical NavigaTion (TALENT)
1 other identifier
interventional
69
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 14, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 14, 2021
CompletedFirst Submitted
Initial submission to the registry
November 9, 2022
CompletedFirst Posted
Study publicly available on registry
May 19, 2023
CompletedMay 19, 2023
May 1, 2023
4.7 years
November 9, 2022
May 17, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Number of failed procedures
Failed procedure is defined as: presence of any residual target lymph node on follow-up imaging
3 months
Secondary Outcomes (2)
Surgical time to remove lymph node
After surgery
LN success
3 months
Study Arms (2)
Navigation
EXPERIMENTALPatients will get the standard of care in the Netherlands with the addition of surgical navigation
Conventional
OTHERPatients will get the standard of care in the Netherlands
Interventions
Patients will be operated with assistance of a navigation system
Eligibility Criteria
You may qualify if:
- Scheduled for open abdominal surgery in which targeted removal of one or more pathological lymph nodes is part of the surgical plan
You may not qualify if:
- Metal implants in the pelvic area
- Contra-indication for contrast enhanced CT scanning
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Netherlands Cancer Institute
Amsterdam, North Holland, 1066 CX, Netherlands
Related Publications (1)
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.
PMID: 39737148DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2022
First Posted
May 19, 2023
Study Start
January 24, 2017
Primary Completion
October 14, 2021
Study Completion
October 14, 2021
Last Updated
May 19, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share