Clinical trial NCT04637334: Superior Vena Cava Reconstruction in Patients on Hemodialysis
Official title: Superior Vena Cava Reconstruction in Patients on Hemodialysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Superior Vena Cava Syndrome
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical outcome and patency
timeFrame: Upto 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Robert Feldtman, M.D.
role: PRINCIPAL_INVESTIGATOR
References: