Navigated Abdominal Lymph Node Dissections

Not Applicable

Completed

• Conditions: Image-guide Surgery; Lymph Node Metastasis
• Interventions: Procedure: Conventional; Procedure: Surgical navigation

• Registration Number: NCT05867095
• Lead Sponsor: The Netherlands Cancer Institute

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.

Study Timeline

• Study Start: 2017-01-24
• Primary Completion: 2021-10-14
• Study Completion: 2021-10-14
• Study First Submitted: 2022-11-09
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-17
• Last Update Submitted: 2023-05-17
• Study First Posted: 2023-05-19
• Last Update Posted: 2023-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional	Conventional	Patients will get the standard of care in the Netherlands
Navigation	Surgical navigation	Patients will get the standard of care in the Netherlands with the addition of surgical navigation

Primary Outcome Measures

Name	Time	Method
Number of failed procedures	3 months	Failed procedure is defined as: presence of any residual target lymph node on follow-up imaging

Secondary Outcome Measures

Name	Time	Method
Surgical time to remove lymph node	After surgery	time from having the surgical field prepared for lymph node localization to actual removal of the lymph node, overall surgical time,
LN success	3 months	individual LN retrieval rate

Trial Locations

Locations (1)

Netherlands Cancer Institute; 🇳🇱 Amsterdam, North Holland, Netherlands