Continuous Suturing Versus Interrupted Clips for Brachiocephalic AV Fistula Creation

Arteriovenous Fistula Clinical Trial

Official title:

A Prospective Randomized Single Blinded Study of Continuous Suturing Versus Interrupted Clips for Brachiocephalic AV Fistula Creation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03024372
• Other study ID #: Sutures vs Clips AVF
• Status: Withdrawn
• Phase: N/A
• Start date: December 2017
• Est. completion date: August 2024

Study information

• Verified date: October 2017
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate a promising strategy to improve maturation and patency rates following creation of AV fistulas and assess whether an anastomosis performed with Anastoclips (interrupted, nonpenetrating) would produce better maturation and/or patency than one performed with conventional suturing techniques.

Description:

This will be a single blind (patient and dialysis center), prospective, randomized trial conducted at a single center. The study intervention will be randomization between conventional sutured anastomosis (Control group) and use of Anastoclips (Treatment group), which provide an interrupted closure without intimal penetration.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Requiring brachiocephalic fistula judged to be best option for access after vein mapping (Surgeons will be required to do 10 cases using Anastoclips prior to enrolling)

• Able to provide informed consent in English or Spanish

• Age 18 years or greater

• With estimated life expectancy of 2 years or more

• Able to comply with study procedures including all scheduled follow-up visits

Exclusion Criteria:

• Unable to provide informed consent in English or Spanish

• Age < 18 years

• With pacemaker, IACD, or other permanent obstructive device on that side (a temporary tunneled dialysis catheter is not an exclusion)

• Unable (or in surgeon's judgment a poor risk) to comply with study procedures and follow-up visits

• With estimated life expectancy of less than 2 years

• Females must be either:

• Of non-childbearing potential, which is defined as post-menopausal (at least 12 months without menses prior to Treatment Day) or documented surgically sterile or post hysterectomy (at least 1 month prior to Treatment Day)

• Or, of childbearing potential, in which case must have a negative urine pregnancy test at Treatment Day

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Fistula

Intervention

Device:
• AV Fistula creation with sutures
End-to-side anastomosis (of AV fistula) is to be constructed using sutures. The incision is to be irrigated and closed using Vicryl, Biosyn and skin glue.
• AV Fistula creation with clips
End-to-side anastomosis (of AV fistula) is to be constructed using clips. The incision is to be irrigated and closed using Vicryl, Biosyn and skin glue.

Locations

Country	Name	City	State
United States	Tampa General Hospital	Tampa	Florida
United States	University of South Florida - South Tampa Campus	Tampa	Florida
United States	USF Health Carol and Frank Morsani Center for Advanced Healthcare	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

References & Publications (13)

Aitken E, Jeans E, Aitken M, Kingsmore D. A randomized controlled trial of interrupted versus continuous suturing techniques for radiocephalic fistulas. J Vasc Surg. 2015 Dec;62(6):1575-82. doi: 10.1016/j.jvs.2015.07.083. Epub 2015 Oct 23. Erratum in: J V — View Citation

Cook JW, Schuman ES, Standage BA, Heinl P. Patency and flow characteristics using stapled vascular anastomoses in dialysis grafts. Am J Surg. 2001 Jan;181(1):24-7. — View Citation

Cooper BZ, Flores L, Ramirez JA, Najjar JG, Abir F, Rayham R, Paladino L, Nguyen M, Panetta TF. Analysis of nonpenetrating clips versus sutures for arterial venous graft anastomosis. Ann Vasc Surg. 2001 Jan;15(1):7-12. — View Citation

Haruguchi H, Nakagawa Y, Uchida Y, Sageshima J, Fuchinoue S, Agishi T. Clinical application of vascular closure staple clips for blood access surgery. ASAIO J. 1998 Sep-Oct;44(5):M562-4. — View Citation

Nguyen KP, Teruya T, Alabi O, Sheng N, Bianchi C, Chiriano J, Dehom S, Abou-Zamzam A. Comparison of Nonpenetrating Titanium Clips versus Continuous Polypropylene Suture in Dialysis Access Creation. Ann Vasc Surg. 2016 Apr;32:15-9. doi: 10.1016/j.avsg.2015 — View Citation

Schild AF, Pruett CS, Newman MI, Raines J, Petersen F, Konkin T, Kim P, Dickson C, Kirsch WM. The utility of the VCS clip for creation of vascular access for hemodialysis: long-term results and intraoperative benefits. Cardiovasc Surg. 2001 Dec;9(6):526-30. — View Citation

Shenoy S, Miller A, Petersen F, Kirsch WM, Konkin T, Kim P, Dickson C, Schild AF, Stewart L, Reyes M, Anton L, Woodward RS. A multicenter study of permanent hemodialysis access patency: beneficial effect of clipped vascular anastomotic technique. J Vasc S — View Citation

Sidawy AN, Gray R, Besarab A, Henry M, Ascher E, Silva M Jr, Miller A, Scher L, Trerotola S, Gregory RT, Rutherford RB, Kent KC. Recommended standards for reports dealing with arteriovenous hemodialysis accesses. J Vasc Surg. 2002 Mar;35(3):603-10. Review. — View Citation

Sukhatme VP. Vascular access stenosis: prospects for prevention and therapy. Kidney Int. 1996 Apr;49(4):1161-74. Review. — View Citation

Suresh K. An overview of randomization techniques: An unbiased assessment of outcome in clinical research. J Hum Reprod Sci. 2011 Jan;4(1):8-11. doi: 10.4103/0974-1208.82352. — View Citation

Zeebregts C, van den Dungen J, Buikema H, van der Want J, van Schilfgaarde R. Preservation of endothelial integrity and function in experimental vascular anastomosis with non-penetrating clips. Br J Surg. 2001 Sep;88(9):1201-8. — View Citation

Zeebregts CJ. Randomized clinical trial of continuous sutures or non-penetrating clips for radiocephalic arteriovenous fistula (Br J Surg 2004; 91: 1438-1442). Br J Surg. 2005 May;92(5):654-5. — View Citation

Zhou XH, Melfi CA, Hui SL. Methods for comparison of cost data. Ann Intern Med. 1997 Oct 15;127(8 Pt 2):752-6. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to loss of primary patency		one year post surgery
Secondary	Time to loss of secondary patency		one year post surgery
Secondary	Time to loss of assisted primary patency		one year post surgery
Secondary	Rate of functional maturation	in patients on dialysis	one year post surgery
Secondary	Time to functional maturation	in patients on dialysis	one year post surgery
Secondary	Rate of assumed maturation	in patients not on dialysis	one year post surgery
Secondary	Time to assumed maturation	in patients not on dialysis	one year post surgery
Secondary	Rate of complications	thrombosis/thrombectomy, stenosis, skin erosion, limb swelling, steal syndrome, bleeding and hematoma formation at surgical site, surgical-site-related infection, access-related infection, rupture, revision	30 days post surgery
Secondary	Rate of intervention	to maintain patency	five years post surgery
Secondary	Operative cost		duration of surgery
Secondary	Overall cost	Overall cost of surgery itself defined as from surgery to point of hospital discharge, anticipated to be in days	time of surgery to time of hospital discharge (can range from 1 day to 1 week or more)
Secondary	Time to loss of primary patency		5 years post surgery
Secondary	Time to loss of assisted primary patency		5 years post surgery
Secondary	Time to loss of secondary patency		5 years post surgery

External Links

•   US Renal Data System