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

  • Netherlands
    • 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
Procedure: Surgical navigation
Patients will be operated with assistance of a navigation system
Other: Conventional
Patients will get the standard of care in the Netherlands
Procedure: Conventional
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

The Netherlands Cancer Institute

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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