Balloon-Assisted Maturation of Autogenous Arteriovenous Fistulae

NCT04263116 | Completed

• 1 other identifier: R. 17.12.44
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Background: There are several studies that document the safety and efficacy of the balloon-assisted maturation (BAM) technique. Ultimately, there are also studies that report its possible negative consequences such as fibrosis and restenosis of venous outflow, leading to malfunctioning arteriovenous fistula (AVF). Thus, in an effort to increase the number of primary AVFs, shorten maturation times, and reduce the number of indwelling catheters, we ascertain the BAM technique within this study to optimize access care and maximize use of AVFs. The balloon assisted maturation approach specifically and aggressively dilates the entire usable segment of the AVF. Methods: This is a randomized prospective study conducted in the department of vascular surgery, Mansoura University Hospitals, including patients with hemodialysis access creation between June 2017 and May 2019. Three hundred patients were recruited from a total of 648 primary AVF creation cases. Patients were divided into two groups; Group (A) Balloon assisted maturation (BAM) (n=157) 52.3 % technique had been done while in the other Group (B) the usual maneuver was used (NO BAM) (n=143) 47.7%. Preoperative duplex was done for all cases to assess suitability. Intraoperative venography was the initial step following surgical exposure of the assigned veins to ascertain continuity and unlimited flow of the superficial vein. Balloon dilatation by 1 mm larger than the size of the vein, sparing the spatulated end of the vein followed by post-dilatation venography to reveal any injury and assess the success of dilatation process. All cases were completed as an end to side anastomosis. Patients were followed clinically and radiologically at regular visits in the 2nd, 4th and 6th week post-procedure, assessing the flow rate, vein depth and diameter via duplex US examination. Results: Patients age ranged from 19 to 89 (mean 51.17 ±15.5) years. The average maturation time was 3.7 weeks (SD ± 1.3 w) and 5.91 weeks (SD ± 2.2 w) for the BAM and non-BAM groups, respectively. Eighty-seven cases (88.7 %) with a pre-operative vein diameter of 3 mm or less, that underwent BAM showed early maturation and started dialysis within 2-4 weeks (68 cases 70%). On the other hand, 28 cases (45.2%) with a vein diameter equal or less than 3 mm in the NO BAM group failed to get mature. Both successful functional maturation (95%) and complication rates (9.6 %) were higher among cases of the BAM group compared to 80.4% maturation rate and 5 % complication in the NO BAM group. The higher complication rate may be attributed to the large number of cases. Conclusion: Balloon-assisted maturation has a pivotal role to help the dialysis society meet the goals of the Fistula First Initiative; It can achieve an accelerated functional maturation of AVF in cases of small caliber veins, with access to early dialysis, thus decreasing the indwelling catheter-related complications.

Conditions

Hemodialysis Access Failure

Outcome Measures

Primary Outcomes (3)

• Flow rate of the target vein

  Radio-logically measure the flow rate in the vein

  6 weeks

• Diameter of the target vein

  Radio-logically measure the vein diameter

  6 weeks

• Depth of the target vein

  Radio-logically measure the vein depth from the skin

  6 weeks

Study Arms (2)

BAM group

EXPERIMENTAL

Balloon assisted maturation

Procedure: Balloon Assisted Maturation

NO BAM

EXPERIMENTAL

NO Balloon assisted maturation

Procedure: Balloon Assisted Maturation

Interventions

Balloon Assisted Maturation PROCEDURE

Angioplasty was performed under direct vision with or without the use of a guidewire using a 1 mm larger balloon than the size of the vein. BAM is performed over the whole length of the vein sparing the spatulated end of the vein

BAM group; NO BAM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Any patient who need arterio-venous fistula formation in the upper limb

You may not qualify if:

• Patients who underwent salvage procedures to improve maturation, i.e. secondary maturation
• Those who could not give informed consent

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university

Al Mansurah, 35511, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Block randomization
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 10, 2020
• Study Start: July 25, 2017
• Primary Completion: May 25, 2019
• Study Completion: May 30, 2019
• Last Updated: February 10, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)