NCT06480331

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: University of Malaya · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an experimental study employing a prospective randomized controlled trial to determine the efficacy of ultrasound-guided fistuloplasty compared to fluoroscopy-guided fistuloplasty in patients with arteriovenous access flow dysfunction. After assessing for eligibility, patients will be randomized equally with a ratio 1:1 to ultrasound-guided fistuloplasty group and fluoroscopy-guided fistuloplasty group. Both interventions will be done in operation theatre to maintain sterility. 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. Fluoroscopy is used in the control group to assess for 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.

Conditions

• Fistulas Arteriovenous

Interventions

Type	Name	Description
PROCEDURE	Ultrasound-guided fistuloplasty	Radiation free fistuloplasty
PROCEDURE	Fluoroscopy-guided fistuloplasty	Conventional fistuloplasty

Timeline

• Start date: 2023-07-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2024-06-28
• Last updated: 2024-06-28

Locations

2 sites across 1 country: Malaysia