Radiation Free Fistuloplasty is the Way Forward
A Randomized Controlled Study on the Efficacy of Ultrasound-guided Fistuloplasty in Comparison to Fluoroscopy-guided Fistuloplasty in Patients With Arteriovenous Access Flow Dysfunction
University of Malaya
54 participants
Jul 1, 2023
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to study effectiveness of ultrasound-guided fistuloplasty in comparison to conventional fistuloplasty in patients with arteriovenous access flow dysfunction. The main question it aims to answer is: To investigate patencies in patients with arteriovenous access flow dysfunction receiving ultrasound-guided fistuloplasty versus fluoroscopy-guided fistuloplasty at 6 months Participants will: * be randomized equally to ultrasound-guided fistuloplasty group and fluoroscopy-guided fistuloplasty group. * visit clinic at one month, three month \& six months for checkups and tests.
Eligibility
Inclusion Criteria8
- Patient able to comprehend English or Malay language.
- Patient aged ⩾18 years and ⩽80 years.
- Patient is willing to comply with protocol.
- Native AVF that is able to provide prescribed dialysis consistently with 2 needles for \>2/3 of dialysis sessions within 4 consecutive weeks.
- Patient has a reasonable expectation of remaining on haemodialysis for 6 months.
- Dampened thrill or pulsatile flow.
- Volume flow (VF) \<500 ml/min.
- Severe stenosis (\>50%) of arteriovenous (AV) access measured on color image and confirmed by peak systolic velocity (PSV) ratio of ≥3 in the inflow artery, anastomosis, or in the outflow vein.
Exclusion Criteria15
- Prior history of fistuloplasty.
- Thrombosed or completely occluded fistula or outflow vein.
- Non-mature AVF.
- Arteriovenous grafts.
- Suspected central vein stenosis/ cephalic arch stenosis - arm edema or Doppler detected suspicion of the same.
- Non consenting patient.
- Metastatic cancer or terminal medical condition.
- Limited life expectancy (\<6 months).
- Blood coagulation disorders (haemophilia/ Von Willebrand disease/ clotting factor deficiencies/ liver disease).
- Connective tissue disease (rheumatoid arthritis/ lupus).
- Sepsis or active infection.
- Planned access abandonment within 6 months (eg, peritoneal dialysis or transplant).
- Pregnant women or women of childbearing potential who are not following an effective method of contraception.
- Allergy or other known contraindication to iodinated media contrast.
- Patient enrolled in another access maintenance trial.
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Interventions
Radiation free fistuloplasty
Conventional fistuloplasty
Locations(2)
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NCT06480331