Endovascular vs Surgical Techniques for Dialysis Fistula Creation

(ESAVFO Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Age below 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 0-6 weeks

21 Participants Needed

Trial Summary

What is the purpose of this trial?

Arteriovenous fistulas (AVFs) are the preferred type of vascular access for dialysis, but many of them fail to mature. There are two techniques of creating AVFs either the traditional way with surgery( Surgical AVFs) or novel per-cutaneous technique Endo- AVFs. Investigators will pilot an randomized clinical trial of endo-AVFs and surgical AVFs at University of Alabama at Birmingham to determine the feasibility of patient recruitment, randomization, and retention. This pilot study will set the stage for a full-scale randomized clinical trial in future.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Endo-vascular AVF and Surgical AVF for dialysis fistula creation?

Research shows that endovascular arteriovenous fistula (endoAVF) creation may have similar outcomes to surgical arteriovenous fistula (sAVF) creation in terms of fistula maturation and procedural success, but with potentially lower medical costs. However, the evidence is of low certainty, and more studies are needed to confirm these findings. ^{1 2 3 4 5}

Is the endovascular creation of dialysis fistulas safe compared to surgical methods?

The safety of endovascular fistula creation compared to surgical methods is not well-established due to limited and low-certainty evidence. Some studies suggest that endovascular methods may have similar safety profiles to surgical ones, but more research is needed to confirm this. ^{1 2 5 6 7}

How does the endovascular treatment for dialysis fistula creation differ from surgical methods?

The endovascular approach to creating a dialysis fistula is unique because it does not require open surgery, unlike the traditional surgical method. This minimally invasive technique may offer an alternative for patients who prefer or require a less invasive option for hemodialysis access. ^{1 8 9 10 11}

Eligibility Criteria

This trial is for adults over 18 who need an arteriovenous fistula (AVF) for dialysis and can have either an endovascular AVF or a surgical upper arm AVF, as shown by preoperative ultrasound. It's not for those under 18 or patients eligible only for a low forearm AVF.

Inclusion Criteria

My ultrasound before surgery showed I can have a special type of vein access for dialysis.

I am 18 or older and scheduled for an arteriovenous fistula procedure.

Exclusion Criteria

I am under 18 years old.

I am eligible for a specific type of arm vein access for dialysis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either surgical AVF creation or endo-vascular AVF creation

0-6 weeks

1 visit (in-person) for procedure

Follow-up

Participants are monitored for fistula maturity and survival

2 years

Regular visits for ultrasound assessments

Treatment Details

Interventions

• Endo-vascular AVF
• Surgical AVF

Trial Overview The study compares two methods of creating dialysis access: the traditional surgery (Surgical AVFs) and a newer, less invasive technique using catheters (Endo-AVFs). Participants will be randomly assigned to one of these techniques at the University of Alabama at Birmingham.

Participant Groups

Group I: Endo-vascular AVF Experimental Treatment 1 Intervention

Participants who initiated dialysis with a catheter or have advanced chronic kidney disease ,these patients who an endo-vascular AVF intervention group that will undergo a per-cutaneous AVF creation.

Group II: Surgical AVFs Active Control 1 Intervention

Participants who initiated dialysis with a catheter or have advanced chronic kidney disease ,these patients who an Surgical AVF intervention group that will undergo a routine surgical AVF creation.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Findings from Research

In a pilot study involving 36 older adults with end-stage kidney disease, both arteriovenous fistulas (AVF) and arteriovenous grafts (AVG) showed a primary access failure rate of 31%, indicating similar initial outcomes for both types of vascular access.

Successful cannulation rates were slightly higher for AVG (62%) compared to AVF (50%), but the differences were not substantial enough to favor one method over the other, suggesting that further research with larger sample sizes is needed to determine the best option for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arteriovenous Fistula Versus Graft Access Strategy in Older Adults Receiving Hemodialysis: A Pilot Randomized Trial. Robinson, T., Geary, RL., Davis, RP., et al.[2022]

The endovascular creation of arteriovenous fistulas (endoAVF) shows a high technical success rate of 98% and a maturation rate of 87%, indicating it is an effective option for patients with renal failure based on a systematic review of 19 studies involving 1,929 patients.

The safety profile of endoAVF is comparable to traditional surgical methods, with a complication rate of 7%, but further randomized controlled trials are needed to strengthen the evidence for clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous endovascular arteriovenous fistula: A systematic review and meta-analysis. Sun, JB., Liu, CC., Shen, X., et al.[2022]

Endovascular arteriovenous fistula (AVF) creation is a minimally invasive procedure with a high technical success rate of 97.5% and a 90-day maturation rate of 89.3%, based on a systematic review of 7 studies involving 300 patients.

The procedure has a low complication rate of 5.5%, indicating it is a safe alternative to traditional surgical AVF creation, although its efficacy compared to surgical methods has not been directly established.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review, meta-analysis, and meta-regression of the efficacy and safety of endovascular arteriovenous fistula creation. Yan Wee, IJ., Yap, HY., Tang, TY., et al.[2020]

Systemic anticoagulation during surgical access formation for dialysis significantly increases the risk of bleeding complications, with a risk ratio of 7.18 based on four trials involving 411 participants.

While systemic anticoagulation did not improve overall access patency rates, it did show a significant improvement in patency for arteriovenous fistulas (AVF) alone, with a risk ratio of 0.57, indicating a potential benefit for this specific type of access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of systemic intraoperative anticoagulation during arteriovenous access formation for dialysis. Smith, GE., Souroullos, P., Cayton, T., et al.[2018]

Hemodialysis is the primary treatment for end-stage renal disease, and creating a good vascular access through an arteriovenous (AV) fistula is crucial for successful treatment.

The end-to-side anastomosis technique between the radial artery and cephalic vein for creating a radiocephalic AV fistula has demonstrated excellent outcomes, emphasizing the importance of proper surgical methods and preoperative imaging for optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief overview of surgical aspect of autologous arterio-venous fistula for dialysis access. Kashyap, NK., Danish, AF., Magatapalli, K., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparison between Surgical and Endovascular Hemodialysis Arteriovenous Fistula Interventions and Associated Costs. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

A Comparison Between the Efficacy and Safety of Endovascular Arteriovenous Fistula Creation and Surgical Fistula Creation: A Systematic Review and Meta-Analysis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Arteriovenous Fistula Versus Graft Access Strategy in Older Adults Receiving Hemodialysis: A Pilot Randomized Trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Surgeon Characteristics and Dialysis Vascular Access Outcomes in the United States: A Retrospective Cohort Study. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Percutaneous endovascular arteriovenous fistula: A systematic review and meta-analysis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

A systematic review, meta-analysis, and meta-regression of the efficacy and safety of endovascular arteriovenous fistula creation. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of systemic intraoperative anticoagulation during arteriovenous access formation for dialysis. [2018]

8. Turkey pubmed.ncbi.nlm.nih.gov

Patient oriented management for the creation of arteriovenous fistula for hemodialysis. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Brief overview of surgical aspect of autologous arterio-venous fistula for dialysis access. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Endovascular Creation of an Arteriovenous Fistula (endoAVF) for Hemodialysis Access: First Results. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Endovascular Proximal Forearm Arteriovenous Fistula for Hemodialysis Access: Results of the Prospective, Multicenter Novel Endovascular Access Trial (NEAT). [2017]