Role of 2 Stages Brachiobasilic Arteriovenous Fistula in Patients Having Central Venous Stenosis with Exhausted Options of Dialysis Access

Not yet recruiting

• Conditions: Brachiobasilic Arteriovenous Fistula

• Registration Number: NCT06846580
• Lead Sponsor: Assiut University

Brief Summary

Central venous stenosis (CVS) is a common problem facing the hemodialysis patients planning to receive dialysis through arteriovenous fistula.

The causes for Central venous stenosis are Subclavian and internal jugular catheters which is related mostly to the frequency and the duration of catheters placement. (5) Also, Smaller caliber central venous catheters (such as peripherally inserted central \[PICC\] and triple-lumen catheters) can also be associated with thrombus formation and Central venous stenosis over a short term.(6) Pacemakers can be a cause which is associated with a 50% prevalence of subclavian vein stenosis.(7) Subclavian catheter placement is a particularly high risk, with the development of subclavian vein stenosis in approximately 25%-50% of patients in various studies.(8,9) The problem now is there is a hemodialysis patient with exhausted options for AVF and a patent basilic vein but the patient has ipsilateral Central venous stenosis. In previous studies, when creating an AVF over central venous stenosis , the investigators preferred to create a Radiocephalic AVF or Brachiocephalic AVF if Radiocephalic AVF is not available. (10) our study proposing the 2 stage brachiobasilic fistula for patients otherwise have no other option for arteriovenous fistula.

Staging the Brachiobasilic procedure will avoid larger incision with the need for general anesthesia until functioning fistula is ensured and central venous stenosis has been delt with.

Detailed Description

Central venous stenosis (CVS) is a common problem facing the hemodialysis patients planning to receive dialysis through arteriovenous fistula. The true incidence and prevalence of Central venous stenosis in the ESRD population is unknown because most studies of Central venous stenosis are limited to symptomatic patients. Central venous stenosis may remain asymptomatic because clinical symptoms and signs of Central venous stenosis often develop only after an AVF is placed in the ipsilateral extremity and the impediment to increased blood flow is unmasked. (1) Retrospective investigations of symptomatic HD patients with various accesses using duplex ultrasonography or angiography have reported Central venous stenosis prevalences of 19%-41%. (2-4) The causes for Central venous stenosis are Subclavian and internal jugular catheters which is related mostly to the frequency and the duration of catheters placement. (5) Also, Smaller caliber central venous catheters (such as peripherally inserted central \[PICC\] and triple-lumen catheters) can also be associated with thrombus formation and Central venous stenosis over a short term.(6) Pacemakers can be a cause which is associated with a 50% prevalence of subclavian vein stenosis.(7) Subclavian catheter placement is a particularly high risk, with the development of subclavian vein stenosis in approximately 25%-50% of patients in various studies.(8,9) The problem now is there is a hemodialysis patient with exhausted options for AVF and a patent basilic vein but the patient has ipsilateral Central venous stenosis. In previous studies, when creating an AVF over central venous stenosis , the investigators preferred to create a Radiocephalic AVF or Brachiocephalic AVF if Radiocephalic AVF is not available. (10) our study proposing the 2 stage brachiobasilic fistula for patients otherwise have no other option for arteriovenous fistula.

Staging the Brachiobasilic procedure will avoid larger incision with the need for general anesthesia until functioning fistula is ensured and central venous stenosis has been delt with.

our Aims are : Evaluates the efficacy and safety of creation of a Brachiobasilic fistula in hemodialysis patients with central venous stenosis Evaluate the outcomes of Superficialization of the basilic vein after percutaneous transluminal angioplasty of the central venous stenosis

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-13
• Study First Submitted QC: 2025-02-20
• Last Update Submitted: 2025-02-20
• Study First Posted: 2025-02-26
• Last Update Posted: 2025-02-26
• Study Start: 2025-04-01
• Primary Completion: 2027-12-01
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Haemodialysis patients with asymptomatic central venous stenosis that have only basilic vein feasible for creating AVF in one upper limb with exhausted other options for AVF
• Age > 18
• Patent brachial artery by duplex with PSV > 45 cm/s
• Patent Basilic vein with diameter > 3 mm

Exclusion Criteria

• Patient with other arteriovenous access options
• Patient not fit for surgery
• Patient with Peripheral arterial disease at Upper limb
• Patient with history of DVT in upper limb
• Hemodynamically unstable patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Procedural success of 1st stage Brachiobasilic fistula	through study completion, an average of 2 year	Palpable thrill Fistula flow rate with duplex ultrasound
Primary patency	through study completion, an average of 2 year	It is defined as the interval between initial creation of the fistula and its failing that requires endovascular or surgical intervention.
Assisted primary patency	through study completion, an average of 2 year	It is defined as the time interval of the fistula remaining patent (functional) with the aid of endovascular intervention.

Secondary Outcome Measures

Name	Time	Method
complications of the fistula	through study completion, an average of 2 year	Bleeding Infection Thrombosis aneurysm formation Distal limb ischemia Severe venous hypertension.
Fistula maturation	4 weeks after the fistula creation and every 2 weeks up to 24 weeks	It is defined as flow through the fistula greater than 600 ml/minute, vein diameter more than 6 mm and the vein less than 6 mm from the skin and adequate urea clearance with dialysis.