Superior Vena Cava Reconstruction in Patients on Hemodialysis

Superior Vena Cava Syndrome Clinical Trial

— Hemodialysis  

Official title:

Superior Vena Cava Reconstruction in Patients on Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04637334
• Other study ID #: 2013.00.642.A
• Status: Completed
• Start date: September 13, 2014
• Est. completion date: May 6, 2022

Study information

• Verified date: October 2022
• Source: Methodist Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This case study will retrospectively review all SVC syndrome and/or occlusion procedures since January 2009. All patients were given adequate informed consent about the procedure and its benefits and complications.

Definitions of clinical outcomes will adhere to the Subcommittee on Reporting Standards in Venous disease.27 Risk factors and outcomes of these procedures will be retrospectively analyzed. Data collected included preoperative patient demographics, clinical status, noninvasive and invasive imaging, operative procedural details, post-operative complications, post-procedural imaging surveillance, adjunctive/re-intervention procedures, clinical outcome during follow-up, and mortality. Primary endpoints will be clinical outcome and patency. Secondary endpoints will be re-intervention rate and death within 30 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 6, 2022
• Est. primary completion date: May 6, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Superior Vena Cava Syndrome

Intervention

Procedure:
• Superior vena cava reconstruction
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.

Locations

Country	Name	City	State
United States	Methodist Dallas Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical outcome and patency	To report findings in patients with ESRD on hemodialysis who underwent SVC reconstruction	Upto 30 days