A Comparison of mNT-BBAVF and BCAVF in Hemodialysis Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 9/15/2018 |
| Start Date: | April 2016 |
| End Date: | December 2019 |
| Contact: | Changbin Li, M.D. |
| Email: | changbin_li@brown.edu |
| Phone: | 086-21-66302524 |
A Comparison of Modified Non-transposed Brachiobasilic Arteriovenous Fistula and Brachiocephalic Arteriovenous Fistula in Hemodialysis Patients
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.
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.
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).
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).
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.
We found this trial at
2
sites
Shanghai, Shanghai 20007
Principal Investigator: Ai Peng, M.D., Ph.D.
Phone: 086-2166302524
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Providence, Rhode Island 02903
Phone: 401-444-5445
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