Title Endovascular Treatment of Superior Cave Syndromes Reaching the Trifurcation: a Single-Center Case Series

NCT06680999 | Completed

• 1 other identifier: 69HCL24_0299
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Superior vena cava syndrome (SCS) is caused by obstruction of blood flow in the superior vena cava, which allows venous return from the upper half of the body to the heart. The causes are most often oncological, but can also be benign (coagulopathy, Behçet) or iatrogenic (catheterisation, PAC). The surgical management of superior vena cava syndromes (SCS) involves the use of innovative endovascular techniques, which have become the therapy of first choice for symptomatic patients, whether the occlusion occurs in a benign or malignant context. For occlusive lesions involving the trifurcation, there are several surgical approaches and strategies, but very little data on their efficacy. In particular, Y-stenting has been described in several case reports as a means of treating the SCS and keeping the two jugulo-subclavian veins (VJSC) patent. This innovative technique has been used for several years by the vascular surgery team at Hôpital Louis Pradel. The aim of our study is to assess the feasibility and medium-term efficacy of innovative endovascular treatments for SCS involving the trifurcation.

Conditions

Superior Cave Syndrome

Outcome Measures

Primary Outcomes (1)

• Technical success, immediate clinical success

  The primary endpoint will be evaluated by : \- Technical success defined by patency postoperatively and at 1 month follow-up confirmed by phleboscanner. Assessment of patency after revascularisation will be based on CT scan data (if possible) or on the results of ultrasound data (letter from the angiologist) if this is the only test performed. Re-thrombosis of the inferior vena cava (IVC) or one of the two subclavian jugular veins (SCJV) will be sufficient to establish the absence of patency in our study. * Immediate clinical success defined by an improvement in symptoms observed by the medical team, and by a Yu score of less than or equal to 1 postoperatively and at 1 month follow-up.

  The primary endpoint will be evaluated by : - Technical success defined by patency postoperatively and at 1 month follow-up confirmed by phleboscanner. Assessment of patency after revascularisation will be based on CT scan data (if possible) or on the r

Study Arms (1)

Treated patients

All patients treated by endovascular surgery (stenting) at Hospices Civils de Lyon between March 2019 and July 2023 for superior cave syndrome, with lesions reaching the trifurcation (elective involvement of the superior vena cava)

Other: Data collection

Interventions

Data collection OTHER

Preoperative, intraoperative and follow-up data collection: consultation and anesthesia reports, hospitalization reports and imaging data to evaluate the feasibility and efficacy of endovascular treatment of superior vena cava syndromes involving the trifurcation. Data collection will last 1 month and will be performed by a Vascular Surgery resident of the hospital.

Treated patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients treated by endovascular surgery (stenting) at Hospices Civils de Lyon between March 2019 and July 2023 for superior cave syndrome with lesions reaching the trifucation (elective involvement of the superior vena cava)

You may qualify if:

• All patients treated by endovascular surgery (stenting) at Hospices Civils de Lyon between March 2019 and July 2023 for superior cave syndrome

You may not qualify if:

• Minor patients
• Patients unable to give consent
• Patients unable to understand French
• Patients with lesions not reaching the trifurcation (elective involvement of the superior vena cava)

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Vascular and Endovascular Surgery Department, Hôpital Louis Pradel, Hospices Civils de Lyon

Lyon, 69677, France

Location

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: November 8, 2024
• Study Start: January 1, 2024
• Primary Completion: February 1, 2024
• Study Completion: April 1, 2024
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)