Radiation Free Fistuloplasty is the Way Forward

Launched by UNIVERSITY OF MALAYA · Jun 27, 2024

Keywords

ClinConnect Summary

This clinical trial, titled "Radiation Free Fistuloplasty is the Way Forward," is looking at a new method called ultrasound-guided fistuloplasty to treat problems with arteriovenous (AV) access in patients who are on dialysis. The main aim is to see how well this method works compared to the traditional fluoroscopy-guided fistuloplasty, particularly in maintaining good blood flow in the access site over a period of six months.

To participate, individuals need to be between 18 and 80 years old, able to understand English or Malay, and have a specific type of AV access that isn't working well. Participants will be randomly assigned to one of the two treatment groups and will have check-up visits at one, three, and six months to monitor their progress. This study is currently recruiting, and it’s important to note that some individuals may not qualify due to certain health conditions or previous treatments. Being part of this trial could help improve fistula procedures and patient care in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient able to comprehend English or Malay language.
• • 2. Patient aged ⩾18 years and ⩽80 years.
• • 3. Patient is willing to comply with protocol.
• • 4. Native AVF that is able to provide prescribed dialysis consistently with 2 needles for \>2/3 of dialysis sessions within 4 consecutive weeks.
• • 5. Patient has a reasonable expectation of remaining on haemodialysis for 6 months.
• • 6. Dampened thrill or pulsatile flow.
• • 7. Volume flow (VF) \<500 ml/min.
• • 8. 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 Criteria:
• • 1. Prior history of fistuloplasty.
• • 2. Thrombosed or completely occluded fistula or outflow vein.
• • 3. Non-mature AVF.
• • 4. Arteriovenous grafts.
• • 5. Suspected central vein stenosis/ cephalic arch stenosis - arm edema or Doppler detected suspicion of the same.
• • 6. Non consenting patient.
• • 7. Metastatic cancer or terminal medical condition.
• • 8. Limited life expectancy (\<6 months).
• • 9. Blood coagulation disorders (haemophilia/ Von Willebrand disease/ clotting factor deficiencies/ liver disease).
• • 10. Connective tissue disease (rheumatoid arthritis/ lupus).
• • 11. Sepsis or active infection.
• • 12. Planned access abandonment within 6 months (eg, peritoneal dialysis or transplant).
• • 13. Pregnant women or women of childbearing potential who are not following an effective method of contraception.
• • 14. Allergy or other known contraindication to iodinated media contrast.
• • 15. Patient enrolled in another access maintenance trial.