Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
54 participants
INTERVENTIONAL
2023-07-01
2024-12-31
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Ultrasound-guided fistuloplasty
Radiation free fistuloplasty
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.
Fluoroscopy-guided fistuloplasty
Conventional fistuloplasty
Interventions
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Ultrasound-guided fistuloplasty
Radiation free fistuloplasty
Fluoroscopy-guided fistuloplasty
Conventional fistuloplasty
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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University of Malaya
OTHER
Responsible Party
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Locations
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Kuala Lumpur Hospital, Jalan Pahang,
Kuala Lumpur, Kuala Lumpur, Malaysia
University Malaya Medical Centre, Jln Profesor Diraja Ungku Aziz, Seksyen 13,
Petaling Jaya, Kuala Lumpur, Malaysia
Countries
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Central Contacts
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Facility Contacts
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Ehab Bin Said
Role: primary
Ehab Bin Said
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Ghanwat SP, Yeramsetti S, Sahu T, Sheorain V, Grover T, Parakh R et al.
Banerjee S, Patel HM, Sahu T, Sheorain VK, Grover T, Parakh R et al.
Other Identifiers
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NMRR ID-23-01273-4HI
Identifier Type: -
Identifier Source: org_study_id