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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
The Netherlands Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Image-guide Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 9, 2022
Last Updated
May 17, 2023
Sponsor
The Netherlands Cancer Institute
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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

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Navigated Abdominal Lymph Node Dissections

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