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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound-guided fistuloplasty | Experimental | 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. |
|
| Fluoroscopy-guided fistuloplasty | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound-guided fistuloplasty | Procedure | Radiation free fistuloplasty |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Over the course of six months follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ehab Bin Said | Contact | 0196343874 | ehab.said.talib@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kuala Lumpur Hospital, Jalan Pahang, | Recruiting | Kuala Lumpur | Kuala Lumpur | 50586 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19150158 | Background | Pisoni RL, Arrington CJ, Albert JM, Ethier J, Kimata N, Krishnan M, Rayner HC, Saito A, Sands JJ, Saran R, Gillespie B, Wolfe RA, Port FK. Facility hemodialysis vascular access use and mortality in countries participating in DOPPS: an instrumental variable analysis. Am J Kidney Dis. 2009 Mar;53(3):475-91. doi: 10.1053/j.ajkd.2008.10.043. Epub 2009 Jan 15. | |
| 2668564 |
| Label | URL |
|---|---|
| Ghanwat SP, Yeramsetti S, Sahu T, Sheorain V, Grover T, Parakh R et al. | View source |
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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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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 8, 2025 | |
| Reset | Jul 25, 2025 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 4, 2024 | Jun 23, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 26, 2023 | Jun 23, 2024 | ICF_001.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 8, 2025 | Jul 25, 2025 |
| ID | Term |
|---|---|
| D001164 | Arteriovenous Fistula |
| ID | Term |
|---|---|
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
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| Fluoroscopy-guided fistuloplasty |
| Procedure |
Conventional fistuloplasty |
|
| 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 | 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 | Immediately post operation |
| University Malaya Medical Centre, Jln Profesor Diraja Ungku Aziz, Seksyen 13, | Recruiting | Petaling Jaya | Kuala Lumpur | 50603 | Malaysia |
|
| Tordoir JH, de Bruin HG, Hoeneveld H, Eikelboom BC, Kitslaar PJ. Duplex ultrasound scanning in the assessment of arteriovenous fistulas created for hemodialysis access: comparison with digital subtraction angiography. J Vasc Surg. 1989 Aug;10(2):122-8. doi: 10.1067/mva.1989.0100122. |
| 28655388 | Background | Leskovar B, Furlan T, Poznic S, Potisek M, Adamlje A, Kljucevsek T. Ultrasound-guided percutaneous endovascular treatment of arteriovenous fistula/graft. Clin Nephrol. 2017 Supplement 1;88(13):61-64. doi: 10.5414/CNP88FX15. |
| 28393000 | Background | Cho S, Lee YJ, Kim SR. Clinical experience with ultrasound guided angioplasty for vascular access. Kidney Res Clin Pract. 2017 Mar;36(1):79-85. doi: 10.23876/j.krcp.2017.36.1.79. Epub 2017 Mar 31. |
| 23334852 | Background | Wakabayashi M, Hanada S, Nakano H, Wakabayashi T. Ultrasound-guided endovascular treatment for vascular access malfunction: results in 4896 cases. J Vasc Access. 2013 Jul-Sep;14(3):225-30. doi: 10.5301/jva.5000126. Epub 2013 Jan 8. |
| 22265799 | Background | Gorin DR, Perrino L, Potter DM, Ali TZ. Ultrasound-guided angioplasty of autogenous arteriovenous fistulas in the office setting. J Vasc Surg. 2012 Jun;55(6):1701-5. doi: 10.1016/j.jvs.2011.12.016. Epub 2012 Jan 23. |
| 19595550 | Background | Ascher E, Hingorani A, Marks N. Duplex-guided balloon angioplasty of failing or nonmaturing arterio-venous fistulae for hemodialysis: a new office-based procedure. J Vasc Surg. 2009 Sep;50(3):594-9. doi: 10.1016/j.jvs.2009.03.061. |
| 19022786 | Background | Marks N, Hingorani A, Ascher E. New office-based vascular interventions. Perspect Vasc Surg Endovasc Ther. 2008 Dec;20(4):340-5. doi: 10.1177/1531003508327921. Epub 2008 Nov 19. |
| 17437980 | Background | Marks N, Ascher E, Hingorani AP. Duplex-guided repair of failing or nonmaturing arterio-venous access for hemodialysis. Perspect Vasc Surg Endovasc Ther. 2007 Mar;19(1):50-5. doi: 10.1177/1531003506298144. |
| 11012917 | Background | Bacchini G, Cappello A, La Milia V, Andrulli S, Locatelli F. Color doppler ultrasonography imaging to guide transluminal angioplasty of venous stenosis. Kidney Int. 2000 Oct;58(4):1810-3. doi: 10.1046/j.1523-1755.2000.00344.x. |
| 32538115 | Background | Karmota AG. Paclitaxel coated-balloon (PCB) versus standard plain old balloon (POB) fistuloplasty for failing dialysis access. Ann R Coll Surg Engl. 2020 Oct;102(8):601-605. doi: 10.1308/rcsann.2020.0121. Epub 2020 Jun 15. |
| 21531585 | Background | Fox D, Amador F, Clarke D, Velez M, Cruz J, Labropoulos N, Ryan M, Gelman L. Duplex guided dialysis access interventions can be performed safely in the office setting: techniques and early results. Eur J Vasc Endovasc Surg. 2011 Dec;42(6):833-41. doi: 10.1016/j.ejvs.2011.04.020. Epub 2011 May 4. |
| 8630358 | Background | Wittenberg G, Kellner M, Kenn W, Obert A, Schultz G, Trusen A, Tschammler A, Gotz R, Hahn D. [Initial experiences with dilatation of dialysis shunts with color-coded duplex ultrasonography monitoring]. Rofo. 1996 Jan;164(1):38-41. doi: 10.1055/s-2007-1015605. German. |
| Banerjee S, Patel HM, Sahu T, Sheorain VK, Grover T, Parakh R et al. | View source |
| Kim JC, Cho JS et al. | View source |
| D016157 | Vascular Fistula |
| D014652 | Vascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |