Navigated Abdominal Lymph Node Dissections

NCT ID: NCT05867095

Last Updated: 2023-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-24

Study Completion Date

2021-10-14

Brief Summary

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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

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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.

Conditions

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Image-guide Surgery Lymph Node Metastasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Navigation

Patients will get the standard of care in the Netherlands with the addition of surgical navigation

Group Type EXPERIMENTAL

Surgical navigation

Intervention Type PROCEDURE

Patients will be operated with assistance of a navigation system

Conventional

Patients will get the standard of care in the Netherlands

Group Type OTHER

Conventional

Intervention Type PROCEDURE

Patients will be operated using the conventional technique

Interventions

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Surgical navigation

Patients will be operated with assistance of a navigation system

Intervention Type PROCEDURE

Conventional

Patients will be operated using the conventional technique

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Netherlands Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Netherlands Cancer Institute

Amsterdam, North Holland, Netherlands

Site Status

Countries

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Netherlands

References

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Groen HC, Wit EMK, Heerink WJ, Kuhlmann KFD, Nijkamp JA, van Veen R, Schoots IG, Balduzzi S, Zijlmans HJMAA, van Leeuwen PJ, van der Poel HG, Ruers TJM. Surgical navigation for targeted retroperitoneal lymph-node removal: a randomised, controlled, phase 3 trial. EClinicalMedicine. 2024 Jul 26;74:102754. doi: 10.1016/j.eclinm.2024.102754. eCollection 2024 Aug.

Reference Type DERIVED
PMID: 39737148 (View on PubMed)

Other Identifiers

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N16LND

Identifier Type: -

Identifier Source: org_study_id

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