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

February 20, 2025 updated by: Islam Hussein Hassan Ibrahim, Assiut University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Hemodialysis patients with central venous stenosis with exhausted options of dialysis access that has only basilic vein feasible for creation of the fistula

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 2 year
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.
through study completion, an average of 2 year
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.
through study completion, an average of 2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 2 year
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.
4 weeks after the fistula creation and every 2 weeks up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

February 13, 2025

First Submitted That Met QC Criteria

February 20, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 20, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBAVF with CVS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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