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

NCT ID: NCT06846580

Last Updated: 2025-02-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2027-12-31

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

Conditions

Brachiobasilic Arteriovenous Fistula

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

brachiobasilic AVF

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Islam Hussein Hassan Ibrahim

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Islam HH Ibrahim

Role: CONTACT

eslamhussein712@gmail.com

+201016114026

References

Jennings WC, Maliska CM, Blebea J, Taubman KE. Creating arteriovenous fistulas in patients with chronic central venous obstruction. J Vasc Access. 2016 May 7;17(3):239-42. doi: 10.5301/jva.5000507. Epub 2016 Feb 5.

Reference Type: BACKGROUND

PMID: 26847733 (View on PubMed)

Agarwal AK. Central vein stenosis: current concepts. Adv Chronic Kidney Dis. 2009 Sep;16(5):360-70. doi: 10.1053/j.ackd.2009.06.003.

Reference Type: BACKGROUND

PMID: 19695504 (View on PubMed)

Barrett N, Spencer S, McIvor J, Brown EA. Subclavian stenosis: a major complication of subclavian dialysis catheters. Nephrol Dial Transplant. 1988;3(4):423-5. doi: 10.1093/oxfordjournals.ndt.a091691.

Reference Type: BACKGROUND

PMID: 3140128 (View on PubMed)

Schwab SJ, Quarles LD, Middleton JP, Cohan RH, Saeed M, Dennis VW. Hemodialysis-associated subclavian vein stenosis. Kidney Int. 1988 Jun;33(6):1156-9. doi: 10.1038/ki.1988.124.

Reference Type: BACKGROUND

PMID: 2969991 (View on PubMed)

Sticherling C, Chough SP, Baker RL, Wasmer K, Oral H, Tada H, Horwood L, Kim MH, Pelosi F, Michaud GF, Strickberger SA, Morady F, Knight BP. Prevalence of central venous occlusion in patients with chronic defibrillator leads. Am Heart J. 2001 May;141(5):813-6. doi: 10.1067/mhj.2001.114195.

Reference Type: BACKGROUND

PMID: 11320371 (View on PubMed)

Grove JR, Pevec WC. Venous thrombosis related to peripherally inserted central catheters. J Vasc Interv Radiol. 2000 Jul-Aug;11(7):837-40. doi: 10.1016/s1051-0443(07)61797-7.

Reference Type: BACKGROUND

PMID: 10928518 (View on PubMed)

Agarwal AK. Central vein stenosis. Am J Kidney Dis. 2013 Jun;61(6):1001-15. doi: 10.1053/j.ajkd.2012.10.024. Epub 2013 Jan 3.

Reference Type: BACKGROUND

PMID: 23291234 (View on PubMed)

MacRae JM, Ahmed A, Johnson N, Levin A, Kiaii M. Central vein stenosis: a common problem in patients on hemodialysis. ASAIO J. 2005 Jan-Feb;51(1):77-81. doi: 10.1097/01.mat.0000151921.95165.1e.

Reference Type: BACKGROUND

PMID: 15745139 (View on PubMed)

Clark DD, Albina JE, Chazan JA. Subclavian vein stenosis and thrombosis: a potential serious complication in chronic hemodialysis patients. Am J Kidney Dis. 1990 Mar;15(3):265-8. doi: 10.1016/s0272-6386(12)80772-4.

Reference Type: BACKGROUND

PMID: 2305766 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/26847733/

Related Info

Other Identifiers

BBAVF with CVS

Identifier Type: -

Identifier Source: org_study_id