Superior Vena Cava Reconstruction in Patients on Hemodialysis

NCT04637334 | Completed

• 1 other identifier: 2013.00.642.A
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The treatment objective for patients with SVC syndrome secondary to both malignant and benign etiologies is to reduce the elevated central venous pressures.1 However, the strategies are contingent upon the underlying disease process. Thus the management of SVC syndrome ranges from medical or supportive care to surgical bypass,3 and it is important for physicians to understand the varied treatment modalities of this potentially life-threatening disease.17 Fortunately, the overwhelming majority of patients with SVC syndrome secondary to benign causes develop a physiologic compensation for the obstruction that can be treated with anticoagulation and endovascular modalities. Intervention for symptomatic relief may not be required.1 An endovascular approach is the current standard of care to relieve SVC obstruction due to malignancy to obtain prompt relief of the rapidly emerging symptoms and improve quality of life,3 keeping in mind the short life expectancy of these patients. The role of endovascular therapy in SVC syndrome of nonmalignant etiology is undecided because the long-term durability of this treatment method remains to be assessed.

Conditions

Superior Vena Cava Syndrome

Outcome Measures

Primary Outcomes (1)

• Clinical outcome and patency

  To report findings in patients with ESRD on hemodialysis who underwent SVC reconstruction

  Upto 30 days

Interventions

Superior vena cava reconstruction PROCEDURE

Endovascular therapy with percutaneous transluminal angioplasty (PTA) and, in recent years, with stenting of the SVC, has been performed with increasing frequency. An endovascular approach is the current standard of care to relieve SVC obstruction due to malignancy to obtain prompt relief of the rapidly emerging symptoms and improve quality of life,3 keeping in mind the short life expectancy of these patients. The role of endovascular therapy in SVC syndrome of nonmalignant etiology is undecided because long-term durability of this treatment method remains to be assessed.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent SVC bypass procedures from January 2010 to June 2013 at Methodist Dallas Medical Center will be screened for participation in the study.

You may qualify if:

• Age ≥ 18 years
• Presence of SVC syndrome or SVC occlusion
• Presence of ESRD on hemodialysis
• Presence of upper extremity or neck access, either catheter or surgical fistula
• Patients who have received endovenous or open bypass reconstruction of the SVC secondary to SVC syndrome or SVC occlusion

You may not qualify if:

• Patients who have not undergone endovenous or open bypass reconstruction of the SVC secondary to SVC syndrome or SVC occlusion

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Superior Vena Cava Syndrome

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Robert Feldtman, M.D.

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: November 19, 2020
• Study Start: September 13, 2014
• Primary Completion: May 6, 2022
• Study Completion: May 6, 2022
• Last Updated: March 23, 2026

Record last verified: 2022-10

Locations

US (1)