Radiation Free Fistuloplasty is the Way Forward

NCT06480331 | Recruiting

• 1 other identifier: NMRR ID-23-01273-4HI
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Fistulas Arteriovenous

Keywords

Endovascular treatments; Percutaneous; Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• To capture data regarding variables that may affect patency of arteriovenous access flow dysfunction post ultrasound-guided fistuloplasty versus fluoroscopy-guided fistuloplasty

  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

  Immediately post operation

• To compare complication rates in patients with arteriovenous access flow dysfunction receiving ultrasound-guided fistuloplasty versus fluoroscopy-guided fistuloplasty

  Immediately post operation

Study Arms (2)

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.

Procedure: Ultrasound-guided fistuloplasty

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.

Procedure: Fluoroscopy-guided fistuloplasty

Interventions

Ultrasound-guided fistuloplasty PROCEDURE

Radiation free fistuloplasty

Ultrasound-guided fistuloplasty

Fluoroscopy-guided fistuloplasty PROCEDURE

Conventional fistuloplasty

Fluoroscopy-guided fistuloplasty

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Prior history of fistuloplasty.
• Thrombosed or completely occluded fistula or outflow vein.
• Non-mature AVF.
• Arteriovenous grafts.
• Suspected central vein stenosis/ cephalic arch stenosis - arm edema or Doppler detected suspicion of the same.
• Non consenting patient.
• Metastatic cancer or terminal medical condition.
• Limited life expectancy (\<6 months).
• Blood coagulation disorders (haemophilia/ Von Willebrand disease/ clotting factor deficiencies/ liver disease).
• Connective tissue disease (rheumatoid arthritis/ lupus).
• Sepsis or active infection.
• Planned access abandonment within 6 months (eg, peritoneal dialysis or transplant).
• Pregnant women or women of childbearing potential who are not following an effective method of contraception.
• Allergy or other known contraindication to iodinated media contrast.
• Patient enrolled in another access maintenance trial.

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (2)

Kuala Lumpur Hospital, Jalan Pahang,

Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

RECRUITING

University Malaya Medical Centre, Jln Profesor Diraja Ungku Aziz, Seksyen 13,

Petaling Jaya, Kuala Lumpur, 50603, Malaysia

RECRUITING

Related Publications (13)

• 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.

  PMID: 19150158 BACKGROUND

• 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.

  PMID: 2668564 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.

  PMID: 28655388 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.

  PMID: 28393000 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.

  PMID: 23334852 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.

  PMID: 22265799 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.

  PMID: 19595550 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.

  PMID: 19022786 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.

  PMID: 17437980 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.

  PMID: 11012917 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.

  PMID: 32538115 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.

  PMID: 21531585 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.

  PMID: 8630358 BACKGROUND

Related Links

• 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.
• Kim JC, Cho JS et al.

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ehab Bin Said

CONTACT

0196343874; ehab.said.talib@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: June 28, 2024
• Study Start: July 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

MY (2)