Fluorescence Guided Minimally-Invasive Resection Of Abdominal Paragangliomas Using Indocyanine Green

Recruiting

• Conditions: Paraganglioma
• Interventions: Drug: Fluorescence guided identification using indocyanine green

• Registration Number: NCT06155734
• Lead Sponsor: Leiden University Medical Center

Brief Summary

This study is exploring whether it's possible to detect paragangliomas (a rare type of tumor) during minimally invasive surgery by using a technique called near-infrared fluorescence imaging, guided by a substance called indocyanine green (ICG). The goal is to see if this method can help surgeons identify and treat paragangliomas more accurately and during minimally invasive procedures.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-11
• Study First Submitted: 2023-11-16
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-01
• Last Update Submitted: 2023-12-01
• Study First Posted: 2023-12-04
• Last Update Posted: 2023-12-04
• Primary Completion: 2023-12-30
• Study Completion: 2024-02-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Diagnosed with abdominal paraganglioma and underwent minimally-invasive surgical resection

Exclusion Criteria

• Open surgical procedures

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Retrospective intervention cohort	Fluorescence guided identification using indocyanine green	-

Primary Outcome Measures

Name	Time	Method
Feasibility of real-time in-vivo identification of suspected paraganglioma's using Near-Infrared-fluorescence ICG imaging	perioperatively/periprocedurally, within 30 minutes after intravenous administration of the fluorescent dye, up until a maximum of 120 minutes after start of surgery.	The primary outcome of this retrospective study is the ability to visually detect the proportion (%) of suspected pre-operatively identified lesions (paraganglioma) in the abdomen during minimally invasive procedures using Near-Infrared-fluorescence ICG imaging

Secondary Outcome Measures

Name	Time	Method
Accuracy of the detection of suspected lesions using Near-Infrared-fluorescence ICG imaging	Postoperatively, at the moment the definitive pathology result is known, approximately five days after surgery	The secondary outcome of this retrospective study is the accuracy, measured by sensitivity and specificity to identify abdominal paragangliomas using using Near-Infrared-fluorescence ICG imaging

Trial Locations

Locations (1)

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands