Arterio-venous FistulaNCT06336226
Brachio Basilic Arterio Venous Fistula One Stage vs Two Stage
A study testing Brachio basilic arterio venous fistula one stage versus two stage in people with Arterio-venous Fistula, run by Assiut University.
Trial summary
The aim of this work was to compare primary failure rates and the primary functional patency of one-stage vs two stage brachiobasilic fistulas to compare the two surgical techniques . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Arterio-venous Fistula
- What is being tested?
- Brachio basilic arterio venous fistula one stage versus two stage
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- May 2024to May 2025
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with end-stage renal disease who had their BBAVFs created either by the one-stage or two- stage technique.
- Patients with brachial artery diameter more than 3 . mm by duplex ultrasound (DUS).
- Patients with triphasic brachial artery by DUS.
- Patients with basilic vein diameter more than 3 mm by DUS.
- Patients who were able to give informed consent.
- Requirements for intervention agreement between the patient and the surgeon.
- Availability of patients for all follow-up visits.
Who cannot join
- Patients who already had a suitable cephalic vein for arteriovenous fistula creation.
- Patients whose brachial artery diameter was less than 3 mm by DUS.
- Patients with brachial artery disease proved by DUS.
- Patients whose basilic vein diameter was less than mm by DUS.
- Patients with ischemic cardiomyopathy.
- Patients with central venous stenosis or occlusion evidenced by duplex scanning.
- Patients with flexion deformity or skin lesions at the site of the fistula or over the course of the vein.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Brachio Basilic Arterio Venous Fistula One Stage Versus Two Stage as a Hemodialysis Access
The aim of this work was to compare primary failure rates and the primary functional patency of one-stage vs two stage brachiobasilic fistulas to compare the two surgical techniques .
Read the detailed description
In the last two decades, there have been concerted efforts by the National Kidney Foundation Dialysis Outcomes Quality Initiative (NKF-DOQI), and the Fistula First Breakthrough Initiative to decrease the use of prosthetic grafts and increase autogenous (native) arteriovenous fistula(AVF) creation for hemodialysis access. When considering vascular access for hemodialysis on the basis of patency, resistance to infection,and associated complications, Native AVF should be selected as the first choice whenever possible. If the cephalic vein in the upper arm is unusable for AVF construction, the basilic vein can be superficialized and anastomosed to the brachial artery at the elbow to form a brachiobasilic arteriovenous fistula (BB)AVF .
If a BB AVF is to be constructed,duplex ultrasound should be used to check the path and size of the basilic vein. It is also important to determine if an adequate length can be mobilized .
The BB fistulae can be formed in one stage or two stages. To date, limited and conflicting data exist regarding primary failure and the patency rates of one-stage and two-stage procedures. Each procedure has advantages and disadvantages Both one-stage and two-stage procedures have their advantages and disadvantages.
Which procedure results in improved outcomes remains unclear. However, the basic principle is to superficialize the basilic vein and make it amenable to needle puncture.
- Conditions
- Arterio-venous Fistula
- Being tested
- Brachio basilic arterio venous fistula one stage versus two stage
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brachio basilic arterio venous fistula one stage versus two stageProcedure or surgery
Comparative study between one stage brachio basilic arterio venous fistula versus two stage
| Study group | Role | What they receive |
|---|---|---|
| One stage group | Active comparator | The one-stage operation was performed under regional anesthesia. A 5-cm incision at the ante cubital fossa identifies the basilic vein. The incision was extended proximally, and the underlying deep fascia was opened. The basilic vein was mobilized up to its junction with the brachial vein. The median cutaneous nerve of the forearm was carefully dissected and preserved. After side branches were ligated, the basilic vein was tunnelled subcutaneously, with a Roberts' forceps maintaining its axial orientation.An end-to-side arteriovenous anastomosisto the brachial artery was performed Receives: Procedure: Brachio basilic arterio venous fistula one stage versus two stage |
| two stage group | Active comparator | he first stage of the two-stage procedure was performed under local anesthesia by formation of the arteriovenous anastomosis with minimal disturbance of the basilic vein. After 4 to 6 weeks, a flow assessment of the AVF by duplex scanning was made to determine if revision of the anastomosis was necessary at the second stage. The second stage was performed under regional anesthesia. The entire length of the basilic vein was mobilized, a"subcutaneous flap" was created, and the vein was positioned anterolaterally. Usually, a further 2 weeks was required before the AVF can be used Receives: Procedure: Brachio basilic arterio venous fistula one stage versus two stage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparative study between one stage brachio basilic arterio venous fistula versus two stage
Measures were primary fistula failure rates and patency rates at specific checkpoints.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study startMay 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Arterio-venous FistulaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelrasheed Mohamed Abdelrasheed, Assiut University
- Investigators
- Haitham A Hasan, Professor, Study chair, Assiut UniversityAhmed Kh Sayed, Lecturer, Study director, Assiut UniversityWael A Abdelgawad, Lecturer, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06336226
- Sponsor's protocol ID
- BB AVF one stage vs two stage
- Status last verified
- Apr 2024
- First submitted
- 22 Mar 2024
- Last updated
- 5 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bashar K, Healy DA, Elsheikh S, Browne LD, Walsh MT, Clarke-Moloney M, Burke PE, Kavanagh EG, Walsh SR. One-stage vs. two-stage brachio-basilic arteriovenous fistula for dialysis access: a systematic review and a meta-analysis. PLoS One. 2015 Mar 9;10(3):e0120154. doi: 10.1371/journal.pone.0120154. eCollection 2015.
PubMed 25751655Kakkos SK, Lampropoulos GC, Nikolakopoulos KM, Tsolakis IA, Papadoulas SI, Papachristou EC, Goumenos D, Lazarides MK. A Systematic Review and Meta-Analysis of Randomized Trials Comparing Two-Stage with One-Stage Brachio-Basilic Vein Fistulas. Vasc Specialist Int. 2018 Sep;34(3):51-60. doi: 10.5758/vsi.2018.34.3.51. Epub 2018 Sep 30.
PubMed 30310807
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brachio Basilic Arterio Venous Fistula One Stage Versus Two Stage as a Hemodialysis Access
- ClinicalTrials.gov ID
- NCT06336226
- Acronym / sponsor ID
- BB AVF one stage vs two stage
- Conditions
- Arterio-venous Fistula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 28 Mar 2024 (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 aim of this work was to compare primary failure rates and the primary functional patency of one-stage vs two stage brachiobasilic fistulas to compare the two surgical techniques .
Detailed description
In the last two decades, there have been concerted efforts by the National Kidney Foundation Dialysis Outcomes Quality Initiative (NKF-DOQI), and the Fistula First Breakthrough Initiative to decrease the use of prosthetic grafts and increase autogenous (native) arteriovenous fistula(AVF) creation for hemodialysis access. When considering vascular access for hemodialysis on the basis of patency, resistance to infection,and associated complications, Native AVF should be selected as the first choice whenever possible. If the cephalic vein in the upper arm is unusable for AVF construction, the basilic vein can be superficialized and anastomosed to the brachial artery at the elbow to form a brachiobasilic arteriovenous fistula (BB)AVF .
If a BB AVF is to be constructed,duplex ultrasound should be used to check the path and size of the basilic vein. It is also important to determine if an adequate length can be mobilized .
The BB fistulae can be formed in one stage or two stages. To date, limited and conflicting data exist regarding primary failure and the patency rates of one-stage and two-stage procedures. Each procedure has advantages and disadvantages Both one-stage and two-stage procedures have their advantages and disadvantages.
Which procedure results in improved outcomes remains unclear. However, the basic principle is to superficialize the basilic vein and make it amenable to needle puncture.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One stage group | Active comparator | Procedure: Brachio basilic arterio venous fistula one stage versus two stageThe one-stage operation was performed under regional anesthesia. A 5-cm incision at the ante cubital fossa identifies the basilic vein. The incision was extended proximally, and the underlying deep fascia was opened. The basilic vein was mobilized up to its junction with the brachial vein. The median cutaneous nerve of the forearm was carefully dissected and preserved. After side branches were ligated, the basilic vein was tunnelled subcutaneously, with a Roberts' forceps maintaining its axial orientation.An end-to-side arteriovenous anastomosisto the brachial artery was performed |
| two stage group | Active comparator | Procedure: Brachio basilic arterio venous fistula one stage versus two stagehe first stage of the two-stage procedure was performed under local anesthesia by formation of the arteriovenous anastomosis with minimal disturbance of the basilic vein. After 4 to 6 weeks, a flow assessment of the AVF by duplex scanning was made to determine if revision of the anastomosis was necessary at the second stage. The second stage was performed under regional anesthesia. The entire length of the basilic vein was mobilized, a"subcutaneous flap" was created, and the vein was positioned anterolaterally. Usually, a further 2 weeks was required before the AVF can be used |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- All patients with end-stage renal disease who had their BBAVFs created either by the one-stage or two- stage technique.
- Patients with brachial artery diameter more than 3 . mm by duplex ultrasound (DUS).
- Patients with triphasic brachial artery by DUS.
- Patients with basilic vein diameter more than 3 mm by DUS.
- Patients who were able to give informed consent.
Key exclusion criteria (7 listed)
- Patients who already had a suitable cephalic vein for arteriovenous fistula creation.
- Patients whose brachial artery diameter was less than 3 mm by DUS.
- Patients with brachial artery disease proved by DUS.
- Patients whose basilic vein diameter was less than mm by DUS.
- Patients with ischemic cardiomyopathy.
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 |
|---|---|---|
| Brachio basilic arterio venous fistula one stage versus two stageComparative study between one stage brachio basilic arterio venous fistula versus two stage | Procedure or surgery | One stage group, two stage group |
Primary outcome
Comparative study between one stage brachio basilic arterio venous fistula versus two stage
Time frame: 1 year
Measures were primary fistula failure rates and patency rates at specific checkpoints.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Background: PubMed 25751655Bashar K, Healy DA, Elsheikh S, Browne LD, Walsh MT, Clarke-Moloney M, Burke PE, Kavanagh EG, Walsh SR. One-stage vs. two-stage brachio-basilic arteriovenous fistula for dialysis access: a systematic review and a meta-analysis. PLoS One. 2015 Mar 9;10(3):e0120154. doi: 10.1371/journal.pone.0120154. eCollection 2015.
- Background: PubMed 30310807Kakkos SK, Lampropoulos GC, Nikolakopoulos KM, Tsolakis IA, Papadoulas SI, Papachristou EC, Goumenos D, Lazarides MK. A Systematic Review and Meta-Analysis of Randomized Trials Comparing Two-Stage with One-Stage Brachio-Basilic Vein Fistulas. Vasc Specialist Int. 2018 Sep;34(3):51-60. doi: 10.5758/vsi.2018.34.3.51. Epub 2018 Sep 30.
- Individual participant dataSharing planned: No
Related trials for Arterio-venous Fistula
Recruiting
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
End Stage Renal Disease
Enrolling by invitationObservational study
Okami Medical ALPHA Registry
Arterial Bleed, Pulmonary Arteriovenous Malformation
Recruiting
Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial
Diabetes, End Stage Renal Disease
Not yet recruiting
A First-In-Man Study to Assess Safety and Efficacy of Ultra High Pressure PTA Balloon ULTRAVIOLET in Treating A-V Fistula Stenosis
Arterio-venous Fistula, Stenosis of Arteriovenous Dialysis Fistula
Active, not recruitingObservational study
Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion (WRAP)
Venous Stenosis, Venous Occlusion
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.
Haitham A Hasan, Professor study chair
Assiut University
Ahmed Kh Sayed, Lecturer study director
Assiut University
Wael A Abdelgawad, Lecturer principal investigator
Al-Azhar University
Questions about this trial
What is this clinical trial studying?
A study testing Brachio basilic arterio venous fistula one stage versus two stage in people with Arterio-venous Fistula, run by Assiut University.
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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed AM Abdelrasheed, Resident (01032735951, ahmeddawood2597@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparative study between one stage brachio basilic arterio venous fistula versus two stage (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06336226, which also lists 2 linked publications.
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 5 Apr 2024.