A Randomized Controlled Study on the Efficacy of Ultrasound-guided Fistuloplasty in Comparison to Fluoroscopy-guided Fistuloplasty in Patients With Arteriovenous Access Flow Dysfunction

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
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• 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.

Locations
Other Locations
Malaysia
Kuala Lumpur Hospital, Jalan Pahang,
RECRUITING
Kuala Lumpur
University Malaya Medical Centre, Jln Profesor Diraja Ungku Aziz, Seksyen 13,
RECRUITING
Petaling Jaya
Contact Information
Primary
Ehab Bin Said
ehab.said.talib@gmail.com
0196343874
Time Frame
Start Date: 2023-07-01
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 54
Treatments
Experimental: Ultrasound-guided fistuloplasty
After cleaning and draping the area of interest, local anaesthesia is given to the puncture site. A puncture needle is used to gain access to the arteriovenous fistula followed by a guide wire. Then, a sheath with an appropriate size is placed and a balloon catheter of adequate size is inserted over the guide wire and inflated for 2 minutes. Ultrasound is used in the subject group to monitor technical success. On table visualization of continuous segment of dilated vein to 5-6mm and continuous flow rate of more than 500ml/min signifies the end points of the procedure. After a satisfactory result, a figure of 8 suture is placed with manual inflow occlusion. Post procedure, patients will be observed for any signs of haematoma or bleeding. If there are no immediate complications, patients will be discharged on the same day.
Active_comparator: Fluoroscopy-guided fistuloplasty
After cleaning and draping the area of interest, local anaesthesia is given to the puncture site. A puncture needle is used to gain access to the arteriovenous fistula followed by a guide wire. Then, a sheath with an appropriate size is placed and a balloon catheter of adequate size is inserted over the guide wire and inflated for 2 minutes. Ultrasound is used in the subject group to monitor technical success. On table fistulogram visualization of less than 30% recoil of the target lesion signifies technical success. After a satisfactory result, a figure of 8 suture is placed with manual inflow occlusion. Post procedure, patients will be observed for any signs of haematoma or bleeding. If there are no immediate complications, patients will be discharged on the same day.
Related Therapeutic Areas
Sponsors
Leads: University of Malaya

This content was sourced from clinicaltrials.gov