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NCT05867095 Clinical Trial

Navigated Abdominal Lymph Node Dissections

Lymph Node Metastasis Clinical Trial

— N16LND  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05867095
Other study ID # N16LND
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 24, 2017
Est. completion date October 14, 2021

Study information
Verified date May 2023
Source The Netherlands Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 69
Est. completion date October 14, 2021
Est. primary completion date October 14, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Surgical navigation
Patients will be operated with assistance of a navigation system
• Conventional
Patients will be operated using the conventional technique

Locations
Country Name City State
Netherlands Netherlands Cancer Institute Amsterdam North Holland

Sponsors (1)
Lead Sponsor Collaborator
The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of failed procedures Failed procedure is defined as: presence of any residual target lymph node on follow-up imaging 3 months
Secondary 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, After surgery
Secondary LN success individual LN retrieval rate 3 months
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