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CompletedNCT07879027Updated Oct 16, 2026

Incidence of Venous Hypertension in Side-to-Side Versus End-to-Side Brachiobasilic Fistulae

An interventional study of Brachiobasilic arteriovenous fistula followed by basilic vein superficialization. and Brachiobasilic arteriovenous fistula in Venous Hypertension, Side-to-Side and End-to-Side, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years 3 months after the study started (first participant enrolled Jul 2021, registered Oct 2026).
Updated Oct 16, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The study aimed to compare the incidence of postoperative venous hypertension between side-to-side (STS) and end-to-side (ETS) brachiobasilic arteriovenous fistulae.

Read the detailed description

Arteriovenous fistula (AVF) is the gold standard for vascular access for hemodialysis (HD) with an overall success rate of about 84.0%, designed to improve the effectiveness of dialysis.

Brachiobasilic arteriovenous fistula (BBAVF) creation may involve either an end-to-side (ETS) or a side-to-side (STS) anastomotic configuration. The STS technique preserves the distal venous segment and may provide additional usable veins for cannulation. However, continued arterialized flow into the distal venous limb may increase forearm venous pressure, thereby predisposing patients to venous hypertension. In contrast, ETS anastomosis directs blood flow primarily toward the proximal venous outflow, thereby reducing distal venous congestion.

02

Conditions studied

  • Venous Hypertension
  • Side-to-Side
  • End-to-Side
  • Brachiobasilic Fistulae
03

In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,932 studies on the registry; 433 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients (>18 years, in pre-dialysis or dialysis status) requiring a native elbow arteriovenous VA for hemodialysis.
  • Patients with normal patency of basilic vein with minimal diameter 3 mm detected by duplex ultrasound (US).
  • Patients with intact radial pulse.
  • Patients with normal patency of brachial artery with minimal diameter 3 mm detected by Duplex US.

Exclusion criteria

Exclusion Criteria:

  • Patients with inadequate peripheral vascular system in both upper limbs. The exclusion will be done by clinical assessment and duplex study.
  • Patients with massive arm swelling due to previous operation (e.g. mastectomy) or previous radiotherapy to shoulder area.
  • Patients with sclerosed basilic vein.
  • Patients with past history of central venous catheter insertion in the ipsilateral side.
  • Heart failure patients with significant reduction in systolic function (ejection fraction lower than 30%).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    ETS group

    Patients who underwent creation of a brachiobasilic arteriovenous fistula followed by basilic vein superficialization.

    Procedure: Brachiobasilic arteriovenous fistula followed by basilic vein superficialization.

  • Experimental
    STS group

    Patients who underwent creation of a brachiobasilic arteriovenous fistula.

    Procedure: Brachiobasilic arteriovenous fistula

Interventions

  • ProcedureBrachiobasilic arteriovenous fistula followed by basilic vein superficialization.

    Patients who underwent creation of a brachiobasilic arteriovenous fistula followed by basilic vein superficialization.

  • ProcedureBrachiobasilic arteriovenous fistula

    Patients who underwent creation of a brachiobasilic arteriovenous fistula.

06

What researchers measure

Primary outcomes

  1. Incidence of postoperative venous hypertension

    Percentage of participants who develop postoperative venous hypertension in the operated upper limb following brachiobasilic arteriovenous fistula creation was recorded.

    Time frame: 6 months after surgery

07

Study locations

1 site
  • Ain Shams University
    Cairo, 11591, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Supporting information: Study protocol

Time frame: After the end of study for one year.

Access criteria: The data will be available upon a reasonable request from the corresponding author.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2021 to primary completion in Jul 2024, 36 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 10, 2026
First posted
Oct 16, 2026
StartActual
Jul 1, 2021
Primary completionActual
Jul 30, 2024
CompletionActual
Jul 30, 2024
Last update
Oct 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 16, 2026
Show all 1 update
  1. Oct 16, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07879027
Responsible party
Khaled ElBeltagy (Assistant Lecturer of Vascular Surgery, Faculty of Medicine, Ain Shams University, Cairo, Egypt., Ain Shams University) — Principal investigator
First posted
Oct 16, 2026
Start date
Jul 1, 2021
Primary completion
Jul 30, 2024
Completion
Jul 30, 2024
Last update
Oct 16, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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