A Comparison of mNT-BBAVF and BCAVF in Hemodialysis Patients

Tongji University

Status: Completed

Conditions: Vascular Fistula

Treatments: Procedure: BCAVF; Procedure: mNT-BBAVF

Study type: Interventional

Funder types: Other

Identifiers

NCT02519933

Shanghai10

Details and patient eligibility

About

A well-functioning vascular access is essential for effective hemodialysis. The native arteriovenous fistula (AVF) is the preferred vascular access because of the lower thrombosis and infection risks compared to either synthetic arteriovenous grafts or central venous catheters. Brachiocephalic arteriovenous fistula (BCAVF) and transposed brachiobasilic arteriovenous fistula (T-BBAVF) are recommended when there is either a primary failure or no suitable vessels for the forearm fistula. However, BCAVF is frequently cannulated at the antecubital fossa, the risks of stenosis and thrombosis are high, which will compromise proper BCAVF function and survival. T-BBAVF is not only technically challenging, but also associates with severe arm swelling and pain. Thus, the investigators introduced a novel modified Non-transposed brachiobasilic arteriovenous fistula (mNT-BBAVF) for long-term hemodialysis patients. To confirm its efficacy, a prospective clinical study would be carried out.

Full description

The study aims to compare the outcomes of a novel modified Non-transposed brachiobasilic arteriovenous fistula (mNT-BBAVF) and the standard brachiocephalic arteriovenous fistula (BCAVF) for long-term hemodialysis patients. Briefly, in mNT-BBAVF, a side-to-side anastomosis between the brachial artery and non-transposed proximal basilic vein is disposed, followed by the ligation of the vein above anastomosis. All the perforating in the surgical field should be ligated. All patients will be followed up for 12 months after surgeries. The outcomes includes: hemodynamic parameters (vessels's diameters, blood flow velocities and blood volumes) detected by ultrasound in 12 months, Complications in 1-month and 12-month, primary patency and secondary patency (cumulative patency).

Enrollment: 84 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age from 18 to 75 years;
• Radial artery diameter <2.0 mm or cephalic vein diameter in the forearm <2.5 mm;
• Brachial artery diameter ≥ 2 mm

Exclusion criteria

• Stenosis or thrombosis present in the draining vein;
• A history of peripheral ischemia in upper extremities;
• Active local or systemic infections;
• Inability to consent for the procedure;
• Patients with previous dysfunctional forearm fistula.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

mNT-BBAVF

Active Comparator group

Description:

Patients in Chronic Kidney Disease (CKD) stage 4-5 without previous dysfunctional fistula access

Treatment:

Procedure: mNT-BBAVF

BCAVF

Active Comparator group

Description:

Patients in CKD stage 4-5 without previous dysfunctional fistula access

Treatment:

Procedure: BCAVF