U Clip Study - Study to Compare U Clip Anastomosis With Conventional Continuous Prolene Anastomosis

NCT00829153 | Unknown Phase 1

• 1 other identifier: H8974
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The requirements for haemodialysis are increasing. There is now acceptance that the most durable AV fistulae are those created from the patients own veins. Use of the radiocephalic arteriovenous fistula as an autologous vascular access dates back to the 1960's. (Brescia MJ, Cimino JE. Appel K, Hurwich BJ. Chronic hemodialysis using venipuncture and a surgically created arteriovenous fistula. N Engl J Med 1966; 275: 1089 - 1092.) Once established, it has good long term survival and a low complication rate. However, the success rate at creation of a useable AV fistula are not good. In a meta-analysis published in 2005, the primary failure rate of a radiocephalic fistula was 15.3% and the primary and secondary patency rates were 62.5% and 66.0% at one year. (Rooijens PPGM, Tordoir JHM, Stijnen T, Burgmans JPJ, Smet AAEA and Yo TI. Radiocephalic wrist arteriovenous fistula for hemodialysis: meta-analysis indicates a high primary failure rate. Eur J Vasc Endovasc Surg 2004; 28, 583-589). Reasons for this are multiple but it appears as though the main determinants are the quality of the patients veins and the technical skill of the surgeon. Low patency rates are also seen in females and those with small veins and arteries. Creating an anastomosis between a small vein and artery is technically challenging. This is traditionally preformed with a continuous prolene suture. Recently, Medtronic have been marketing the U Clip Anastomotic Device. This is a self closing devise which could be called a vascular clip. Reported advantages of this clip include better patency rates and faster operations. However, to our knowledge there is no randomised evidence to support this with regards to AV fistulas. The vascular anastomosis originally developed by Alexis Carrel used interrupted sutures. Over time this was replaced by a continuous suture technique which was felt to be quicker and had similar patency rates. However, microvascular, paediatric and neurovascular surgeons have shown that there are advantages to an interrupted technique. (Hattori H, Killen DA, Green JW. Influence of suture material and technic on patency of anastomosed arteries of less than 1.5mm. Am Surg. 1970; 36: 352 - 354. Cobbett JR. Microvascular surgery. Surg Clin N Am. 1962; 47: 521.). The reasons for the improved patency with interrupted anastomoses are firstly increased anastomotic compliance and flow rate and secondly elimination of the pursestring effect and puckering seen with continuous sutures. In a prospective but non randomised study to compare interrupted U clips with historical published results, the patency rate of coronary anastomoses was 100% at 6 months using the U clips compare to a patency rate of 90 -100% in the published series. (Wolf RK, Alderman EL, Caskey MP et al. Clinical and six month angiographic evaluation of coronary arterial graft interrupted anastomoses by use of a self closing clip device: a multicentre prospective clinical trial. J Thorac cardiovasc Surg 2003; 126(1): 168 - 178.) Reports from single centres have concluded that the U Clips offer the opportunity to create superior interrupted anastomoses for AV fistula, even in patients who would otherwise be considered poor candidates for fistula creation. (Ross JR. Creation of native arteriovenous fistulas with interrupted anastomoses using a self closing clip device - one clinics experience. Journal of vascular Access 2002; 3: 140 - 146). In this report with small numbers, the radiocephalic fistulas had an 8 week maturation rate of 93%. Of the 28 patients having a radiocephalic fistula, 10 had veins of between 1.0 - 1,5mm diameter. The aim of this pilot study will be to assess if there is a clinical difference in the maturation rates of autologous AV fistulae when a clipped anastomosis is compared to a conventional prolene anastomosis.

Conditions

Haemodialysis

Keywords

Fistula patency

Outcome Measures

Primary Outcomes (1)

• A functioning fistula which is used for haemodialysis on three or more occasions.

  Until commencement of dialysis with the fistula

Secondary Outcomes (2)

• Fistula patency as assessed clinically.

  For the life of the fistula

• Need for fistula intervention in order to maintain patency.

  For the life of the fistula

Study Arms (2)

U clip

EXPERIMENTAL

Anastomosis with U clips

Device: U Clip

2

ACTIVE COMPARATOR

Prolene anastomosis

Procedure: Conventional prolene anastomosis

Interventions

U Clip DEVICE

Interuppted nitional clips

U clip

Conventional prolene anastomosis PROCEDURE

Continuous prolene anastomosis

2

Eligibility Criteria

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

You may qualify if:

• Requirement for AV fistula creation for haemodialysis
• Pre operative upper limb venous and arterial duplex scan showing intended arterial lumen diameter of 2mm or more and vein diameter of 3mm or more.

You may not qualify if:

• Use of prosthetic graft for fistula creation.
• Donor arterial lumen diameter less then 2mm
• Recipient venous diameter less than 3mm.
• Proximal venous thrombosis.

Sponsors & Collaborators

• Royal Hobart Hospital: lead

Study Sites (1)

Launceston general Hospital

Launceston, Australia

RECRUITING

Related Publications (1)

• Walker SR. U Clips for arteriovenous anastomosis: a pilot, randomized study. ANZ J Surg. 2012 Sep;82(9):630-2. doi: 10.1111/j.1445-2197.2012.06153.x. Epub 2012 Aug 20.

  PMID: 22900497 DERIVED

Central Study Contacts

Stuart R walker, MBBS

CONTACT

03 6227064; stuart.walker@dhhs.tas.gov.au

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: January 22, 2009
• First Posted: January 26, 2009
• Study Start: January 1, 2007
• Primary Completion: August 1, 2010
• Last Updated: March 16, 2010

Record last verified: 2010-03

Locations

AU (1)