Clinical trial NCT02519933: A Comparison of mNT-BBAVF and BCAVF in Hemodialysis Patients
Official title: A Comparison of Modified Non-transposed Brachiobasilic Arteriovenous Fistula and Brachiocephalic Arteriovenous Fistula in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Fistula
Keywords: hemodialysis
vascular access
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2015-08-11
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Primary unassited patency
timeFrame: 12 months
Secondary outcomes:
measure: Cumulative patency
timeFrame: 12 month
measure: Short-term complications
timeFrame: 1 month
measure: Long-term complications
timeFrame: 12 months
measure: Calculated blood flow volumes of the corresponding fistula segments
timeFrame: 12 months
measure: Diameters of the veins and arteries in the corresponding arm
timeFrame: 12 months
measure: Blood flow velocities of the veins and arteries in the corresponding arm.
timeFrame: 12 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital/Brown University Medicine School
state: Rhode Island
city: Shanghai
country: China
facility: The Division of Nephrology & Rheumatology, Shanghai 10th People's Hospital
state: Shanghai
Study officials:
affiliation: The Division of Nephrology & Rheumatology, Shanghai 10th People's Hospital
name: AI Peng, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: