Venous HypertensionNCT07879027
Incidence of Venous Hypertension in Side-to-Side Versus End-to-Side Brachiobasilic Fistulae
A study testing Brachiobasilic arteriovenous fistula followed by basilic vein superficialization. and Brachiobasilic arteriovenous fistula in people with Venous Hypertension and Side-to-Side, run by Ain Shams University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Hypertension, Side-to-Side, End-to-Side
- What is being tested?
- Brachiobasilic arteriovenous fistula followed by basilic vein superficialization. and Brachiobasilic arteriovenous fistula
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2021to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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%).
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Brachiobasilic arteriovenous fistula followed by basilic vein superficialization., Brachiobasilic arteriovenous fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brachiobasilic arteriovenous fistula followed by basilic vein superficialization.Procedure or surgery
Patients who underwent creation of a brachiobasilic arteriovenous fistula followed by basilic vein superficialization.
Brachiobasilic arteriovenous fistulaProcedure or surgery
Patients who underwent creation of a brachiobasilic arteriovenous fistula.
| Study group | Role | What they receive |
|---|---|---|
| ETS group | Experimental | Patients who underwent creation of a brachiobasilic arteriovenous fistula followed by basilic vein superficialization. Receives: Procedure: Brachiobasilic arteriovenous fistula followed by basilic vein superficialization. |
| STS group | Experimental | Patients who underwent creation of a brachiobasilic arteriovenous fistula. Receives: Procedure: Brachiobasilic arteriovenous fistula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start1 Jul 2021
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous HypertensionStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled ElBeltagy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879027
- Sponsor's protocol ID
- IRB 0003679
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Venous Hypertension in Side-to-Side Versus End-to-Side Brachiobasilic Fistulae
- ClinicalTrials.gov ID
- NCT07879027
- Acronym / sponsor ID
- IRB 0003679
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 16 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aimed to compare the incidence of postoperative venous hypertension between side-to-side (STS) and end-to-side (ETS) brachiobasilic arteriovenous fistulae.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ETS group | Experimental | Procedure: Brachiobasilic arteriovenous fistula followed by basilic vein superficialization.Patients who underwent creation of a brachiobasilic arteriovenous fistula followed by basilic vein superficialization. |
| STS group | Experimental | Procedure: Brachiobasilic arteriovenous fistulaPatients who underwent creation of a brachiobasilic arteriovenous fistula. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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%).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brachiobasilic arteriovenous fistula followed by basilic vein superficialization.Patients who underwent creation of a brachiobasilic arteriovenous fistula followed by basilic vein superficialization. | Procedure or surgery | ETS group |
| Brachiobasilic arteriovenous fistulaPatients who underwent creation of a brachiobasilic arteriovenous fistula. | Procedure or surgery | STS group |
Primary outcome
Incidence of postoperative venous hypertension
Time frame: 6 months after surgery
Percentage of participants who develop postoperative venous hypertension in the operated upper limb following brachiobasilic arteriovenous fistula creation was recorded.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brachiobasilic arteriovenous fistula followed by basilic vein superficialization. and Brachiobasilic arteriovenous fistula in people with Venous Hypertension and Side-to-Side, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative venous hypertension (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.