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NCT Number: NCT06846580

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

brachiobasilic AVF

Procedure

perform 2 stage brachiobasilic AVF in hemodialysis patients with central venous stenosis

Primary outcomes

  1. Procedural success of 1st stage Brachiobasilic fistula

    Time frame: through study completion, an average of 2 year

    Palpable thrill Fistula flow rate with duplex ultrasound

  2. Primary patency

    Time frame: 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.

  3. Assisted primary patency

    Time frame: 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 outcomes

  1. complications of the fistula

    Time frame: through study completion, an average of 2 year

    Bleeding Infection Thrombosis aneurysm formation Distal limb ischemia Severe venous hypertension.

  2. Fistula maturation

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Islam HH Ibrahim

CONTACT

[email protected]

+201016114026

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 26, 2025
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.