Complications of the Cephalic Route in Implantable Site Placement in Children (SitePedia)

Totally implantable venous access devices (TIVADs) offer long-term central venous access for children requiring intravenous treatments. Their use is recommended in infants (31 days - 1 year old) for >31 days of non-peripherally compatible therapy, and in children and adolescents (>1 year old) for any intravenous therapy lasting more than 31 days. Indications include chemotherapy administration and chronic disease management, avoiding repeated peripheral venous punctures and causing less interference with the activities of the patients.

There are several methods for TIVAD placement, but the optimal evidence-based method remains unclear . The two main approaches for TIVAD placement are closed cannulation of a vein, followed by insertion of the catheter in Seldinger technique, and the surgical insertion of the catheter into a vein through an open cut-down technique 5-7. Different location of insertion are possible: by closed cannulation, the catheter is usually placed in subclavian vein, internal jugular vein, and brachiocephalic vein; by open cut-down it can be placed in external jugular vein, axillary vein, or cephalic vein.

Thanks to progress in medical and surgical care, children are nowadays surviving previously fatal illnesses, but with the need of long-term treatments. For this reason, it's essential to preserve their vessel health. With this objective, in the CHU of Angers, physicians prefer trying first the cephalic vein cutdown for TIVAD positioning in children, reserving the use of other venous accesses in case of failure of this procedure or the need for multiple devices implantations.

To date, few reports have been published about cephalic vein cutdown in children. It is a common opinion that this technique can't be successfully performed in patients under a certain limit of weight or age. In this context, the investigators conducted a retrospective single-centre study to analyse the results of cephalic vein cutdown in children. The primary aim was to describe the feasibility of this technique in paediatric population and identify the risks factors associated with its failure. In addition, this study describes indications, outcomes, and complications of TIVAD implantation.

Study Overview

• Status: Not yet recruiting
• Conditions: Device Safety; Surgical Complications
• Intervention / Treatment: Procedure: TIVAD implantation complications

• Study Type: Observational
• Enrollment (Estimated): 426

Contacts and Locations

• Study Contact: Name: Aurora MARIANI; Phone Number: +33 0241353637; Email: aurora.mariani@chu-angers.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients operated in the CHU of Angers

Description

Inclusion Criteria:

• All patients under 18 years who underwent TIVAD implantation between 2012 and 2022.
• Patients for whom cephalic vein cutdown was the first attempted surgical technique for device placement.

Exclusion Criteria:

• Patients who previously had a central venous access

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with TIVAD	Procedure: TIVAD implantation complications; Follow up and post operative outcome of patients with devices implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characteristics of the study group	Risk factors for cephalic vein cutdown failure for TIVAD positioning	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative complications		1 year
cephalic vein cutdown	Post-operative complications of cephalic vein cutdown	1 year
TIVAD removal		1 year

Collaborators and Investigators

• Sponsor: University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2024
• Primary Completion (Estimated): April 15, 2025
• Study Completion (Estimated): April 15, 2025

Study Registration Dates

• First Submitted: October 4, 2024
• First Submitted That Met QC Criteria: October 14, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 14, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 49RC24_0097

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No