Skip to main content
OpenTrials
Completed

NCT Number: NCT05867095

Navigated Abdominal Lymph Node Dissections

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Image-guide Surgery Lymph Node Metastasis Lymphatic Metastasis Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Netherlands Cancer Institute

Amsterdam, North Holland, 1066 CX, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical navigation

Procedure

Patients will be operated with assistance of a navigation system

Conventional

Procedure

Patients will be operated using the conventional technique

Primary outcomes

  1. Number of failed procedures

    Time frame: 3 months

    Failed procedure is defined as: presence of any residual target lymph node on follow-up imaging

Secondary outcomes

  1. 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,

  2. LN success

    Time frame: 3 months

    individual LN retrieval rate

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Registry information

Official study title

Targeted Abdominal Lymph nodE Dissections Randomized for Surgical NavigaTion (TALENT)

Acronym: N16LND

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
May 19, 2023
Registry last updated
May 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.