An interventional study of Ultrasound-guided fistuloplasty and Fluoroscopy-guided fistuloplasty in Fistulas Arteriovenous, sponsored by University of Malaya. Recruiting at 2 sites in Malaysia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-06-28.
Sponsored by University of Malaya · Not applicable, Interventional, and Treatment
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:
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.
267 studies on the registry are indexed under Arteriovenous Fistula; 44 are open to participants now.
This study's planned enrollment of 54 is below the median of 68 across 177 interventional studies indexed under Arteriovenous Fistula.
Browse Arteriovenous Fistula studies →University of Malaya is the lead sponsor of 280 studies on the registry; 55 are open to participants now.
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Exclusion Criteria:
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.
Procedure: 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 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.
Procedure: Fluoroscopy-guided fistuloplasty
Radiation free fistuloplasty
Conventional fistuloplasty
To investigate patencies in patients with arteriovenous access flow dysfunction receiving ultrasound-guided fistuloplasty versus fluoroscopy-guided fistuloplasty at 6 months
The duration of time from intervention to thrombosis or any re-intervention to facilitate, maintain, or re-establish patency
Time frame: 6 months
To capture data regarding variables that may affect patency of arteriovenous access flow dysfunction post ultrasound-guided fistuloplasty versus fluoroscopy-guided fistuloplasty
These includes demographic data (comorbidities, smoking history, gender, patient's age, age of fistula) and anatomic location of lesion and number of lesion.
Time frame: Over the course of six months follow-up
To compare technical success in patients with arteriovenous access flow dysfunction receiving ultrasound-guided fistuloplasty versus fluoroscopy-guided fistuloplasty
Technical success is defined as clinical palpable thrill, radiographic finding of less than 30% recoil and ultrasonographic finding of continuous segment of dilated vein to 5-6mm and continuous flow rate of more than 500ml/min
Time frame: Immediately post operation
To compare complication rates in patients with arteriovenous access flow dysfunction receiving ultrasound-guided fistuloplasty versus fluoroscopy-guided fistuloplasty
This includes thrombosis, pseudoaneurysm and bleeding
Time frame: Immediately post operation
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — No individual participant data will be shared. Results will be published by the investigators in academic journals. Sharing of generated study data will be carried out in several different ways. We plan to make our results available to researchers and potential collaborators interested in ultrasound guided fistuloplasty.
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University of Malaya