A Comparison of mNT-BBAVF and BCAVF in Hemodialysis Patients
Condition: Vascular Fistula
MeSH terms: Vascular Fistula; Fistula
Study type: Interventional

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).
    

Intervention name(s): mNT-BBAVF; BCAVF
Intervention type(s): Procedure; Procedure
Intervention description(s): mNT-BBAVF was performed under local anesthesia. A transverse incision of approximately 4 cm was made in the antecubital area. The basilic vein was isolated, and its side branches were ligated; followed by the isolation of brachial artery. A venotomy of 5 mm was performed, followed an arteriotomy of 5 mm. The two vessels then had a side-to-side anastomosis, followed by the ligation of the vein above anastomosis. All the perforating veins located in an area 2-4 cm down the antecubital fossa from anastomosis were separated and ligated carefully. After surgeries, all patients will be followed up for 12 months. The outcomes are patency (primary unassisted patency and secondary), complications and hemodynamic parameters (diameters, blood velocities and blood volume) detected by Ultrasound.; BCAVF was performed under local anesthesia. A transverse incision of approximately 4 cm in length was made in the medial antecubital area. The cephalic vein was isolated, followed by the isolation of brachial artery. The distal end of cephalic vein was ligated and dissected. Patency of the proximal vein was verified by the warmed saline injection. The artery was then incised after clamping, and an end-to-side anastomosis (4-0 silk suture) between the cephalic vein and the brachial artery was performed. At last the skin is sutured (1-0 silk suture). At last the skin is sutured. After surgeries, all patients will be followed up for 12 months. The outcomes are patency (primary unassisted patency and secondary), complications and hemodynamic parameters detected by Ultrasound.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hemodialysis; vascular access