Anchor Versus Parachute Suturing Technique in Arteriovenous Fistula Creation for Hemodialysis

Arterio-venous Fistula Clinical Trial

Official title:

Anchor Versus Parachute Suturing Technique in Arteriovenous Fistula Creation for Hemodialysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06091839
• Other study ID #: MKSU 50-12-8
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2022
• Est. completion date: January 5, 2024

Study information

• Verified date: October 2023
• Source: Kafrelsheikh University
• Contact: Fouda, MD
• Phone: 201092424389
• Email: ahmed.med_0124[@]med.kfs.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized controlled study to compare the results of two surgical techniques for AVF creation, including the anchor technique (Group A) and parachute technique (Group B).

The study population will be patients referred to the Vascular surgery department for the creation of Hemodialysis access. Patients will be advised to undergo elective surgery for AVF once their renal Glomerular Filtration Rate Estimated (eGFR) is less than 15 ml/min.

primary outcome: Functional Maturation of Arterio-venous Fistula [ Time Frame: Six Months] Ready fistula for cannulation, vein length at least 10 cm, diameter more than 6 mm, depth not more than 6 mm, and ability of the access to deliver a flow rate of 600ml/min and maintain dialysis for 4 hours.

Description:

Introduction

End-stage kidney disease (ESKD) is increasing worldwide and is likely to increase further because of aging populations and the increased prevalence of type II diabetes mellitus. It is a chronic and irreversible condition associated with substantial morbidity and high mortality and constitutes a heavy financial burden on healthcare systems.

The reduced hemodialysis-related mortality rate has increased the need for dependable vascular access. For end-stage renal failure patients, arteriovenous fistulas (AVFs) are the reliable hemodialysis access option. Compared to tunneled central venous catheters, they had a reduced risk of systemic sepsis and a lower overall cardiovascular death rate.

Numerous factors for early failure and "arrested maturation" have been implicated, including abnormal anastomotic hemodynamics, the diameter of the vein, hyperplasia of intima and stenosis or scarring, insufficient arterial flow, and suture technique. The surgical technique is an essential aspect in determining AVF surgery success.

The lack of data supporting any anastomotic suture technique is better in AV access patency, or less complication makes the choice of suture technique for AV access formation dependent on the operator's discretion and their best clinical judgment. For this reason, we conducted prospective research on AVFs created using two distinct continuous suturing techniques, the anchor technique, and the parachute technique, to examine the impact of these two techniques on the initial outcomes of AVFs.

Aim of the work To compare the results of two surgical techniques for AVF creation, including the anchor technique (Group A) and parachute technique (Group B).

Patients and the method Study location: We will submit the study protocol for approval by Kafr ElSheikh medical research ethics committee, faculty of medicine, Kafr ElSheikh University.

Study design: Randomized controlled study will be conducted in the department of vascular surgery in Kafr El Sheikh.

Time of study: We started in march 2022.

Study population: The study population will be patients referred to the Vascular surgery department for the creation of Hemodialysis access. Patients will be advised to undergo elective surgery for AVF once their renal Glomerular Filtration Rate Estimated (eGFR) is less than 15 ml/min.

The number of patients:

This study will be done on 150 cases, 75 cases in group A (anchor technique) and another 75 in group B (parachute technique).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 5, 2024
• Est. primary completion date: January 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Eighteen years of age or older.

• Need for AVF creation for vascular access for planned hemodialysis (within one year), Including distal - Radio-cephalic, proximal brachio-cephalic configurations.

• Vein mapping studies completed 2.5-3 mm minimum vein diameter on mapping.

Exclusion Criteria:

• Ipsilateral proximal venous and arterial occlusion or stenosis

• systemic or local infection at the site planned for AVF creation.

• Anticipated inability to keep 30-day post-operative follow-up appointment.

• Revision AVF, Synthetic graft AVF, or lower limb AVF.

• Patients with absent distal pulses and chronic ischemia of the upper limb.

• Recent cannulation of puncture of the vein within two weeks before its use in AVF creation.

• Vasculitis (collagen diseases)

Related Conditions & MeSH terms

• Arterio-venous Fistula
• Arteriovenous Fistula
• Fistula

Intervention

Other:
• suturing technique in arteriovenous fistula creation for hemodialysis
End-to-side AV anastomosis was created in upper limb between cephalic vein and brachial or radial artery

Locations

Country	Name	City	State
Egypt	Kafrelsheikh University	Kafr Ash Shaykh

Sponsors (1)

Lead Sponsor	Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

References & Publications (12)

Achneck HE, Sileshi B, Li M, Partington EJ, Peterson DA, Lawson JH. Surgical aspects and biological considerations of arteriovenous fistula placement. Semin Dial. 2010 Jan-Feb;23(1):25-33. doi: 10.1111/j.1525-139X.2009.00651.x. — View Citation

Baboolal K, McEwan P, Sondhi S, Spiewanowski P, Wechowski J, Wilson K. The cost of renal dialysis in a UK setting--a multicentre study. Nephrol Dial Transplant. 2008 Jun;23(6):1982-9. doi: 10.1093/ndt/gfm870. Epub 2008 Jan 3. — View Citation

Bray BD, Boyd J, Daly C, Donaldson K, Doyle A, Fox JG, Innes A, Khan I, Peel RK, Severn A, Shilliday I, Simpson K, Stewart GA, Traynor J, Metcalfe W; Scottish Renal Registry. Vascular access type and risk of mortality in a national prospective cohort of haemodialysis patients. QJM. 2012 Nov;105(11):1097-103. doi: 10.1093/qjmed/hcs143. Epub 2012 Aug 20. — View Citation

Celik S, Gok Oguz E, Ulusal Okyay G, Selen T, Ayli MD. The impact of arteriovenous fistulas and tunneled cuffed venous catheters on morbidity and mortality in hemodialysis patients: A single center experience. Int J Artif Organs. 2021 Apr;44(4):229-236. doi: 10.1177/0391398820952808. Epub 2020 Sep 22. — View Citation

Coresh J, Selvin E, Stevens LA, Manzi J, Kusek JW, Eggers P, Van Lente F, Levey AS. Prevalence of chronic kidney disease in the United States. JAMA. 2007 Nov 7;298(17):2038-47. doi: 10.1001/jama.298.17.2038. — View Citation

Ibbotson SH, Walmsley D, Davies JA, Grant PJ. Generation of thrombin activity in relation to factor VIII:C concentrations and vascular complications in type 1 (insulin-dependent) diabetes mellitus. Diabetologia. 1992 Sep;35(9):863-7. doi: 10.1007/BF00399933. — View Citation

Johansen KL, Chertow GM, Gilbertson DT, Herzog CA, Ishani A, Israni AK, Ku E, Li S, Li S, Liu J, Obrador GT, O'Hare AM, Peng Y, Powe NR, Roetker NS, St Peter WL, Saeed F, Snyder J, Solid C, Weinhandl ED, Winkelmayer WC, Wetmore JB. US Renal Data System 2021 Annual Data Report: Epidemiology of Kidney Disease in the United States. Am J Kidney Dis. 2022 Apr;79(4 Suppl 1):A8-A12. doi: 10.1053/j.ajkd.2022.02.001. No abstract available. — View Citation

Konner K, Lomonte C, Basile C. Placing a primary arteriovenous fistula that works--more or less known aspects, new ideas. Nephrol Dial Transplant. 2013 Apr;28(4):781-4. doi: 10.1093/ndt/gfs463. Epub 2012 Nov 2. — View Citation

Lee CP, Chertow GM, Zenios SA. An empiric estimate of the value of life: updating the renal dialysis cost-effectiveness standard. Value Health. 2009 Jan-Feb;12(1):80-7. doi: 10.1111/j.1524-4733.2008.00401.x. — View Citation

Lin PH, Bush RL, Nguyen L, Guerrero MA, Chen C, Lumsden AB. Anastomotic strategies to improve hemodialysis access patency--a review. Vasc Endovascular Surg. 2005 Mar-Apr;39(2):135-42. doi: 10.1177/153857440503900202. — View Citation

Lok CE, Huber TS, Lee T, Shenoy S, Yevzlin AS, Abreo K, Allon M, Asif A, Astor BC, Glickman MH, Graham J, Moist LM, Rajan DK, Roberts C, Vachharajani TJ, Valentini RP; National Kidney Foundation. KDOQI Clinical Practice Guideline for Vascular Access: 2019 Update. Am J Kidney Dis. 2020 Apr;75(4 Suppl 2):S1-S164. doi: 10.1053/j.ajkd.2019.12.001. Epub 2020 Mar 12. Erratum In: Am J Kidney Dis. 2021 Apr;77(4):551. — View Citation

Pozzoni P, Del Vecchio L, Pontoriero G, Di Filippo S, Locatelli F. Long-term outcome in hemodialysis: morbidity and mortality. J Nephrol. 2004 Nov-Dec;17 Suppl 8:S87-95. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Maturation of Arterio-venous Fistula	The suitability of an AVF for successful cannulation for dialysis, ascertained by duplex ultrasound study by measuring vein length at least 10 cm, diameter more than 6 mm, depth for skin not more than 6 mm, and ability of the access to deliver a flow rate of 600ml/min and maintain dialysis for 4 hours.	6 months
Secondary	Complication rate and failure of maturation	Bleeding, infection, steal syndrome, and aneurysmal dilatation at the anastomosis site.	Six Months