Collateral Ligation in Failing Fistulas (CLiFF)

Mass General Brigham

Status

Unknown

Conditions

Hemodialysis Access Failure

Treatments

Procedure: Collateral vein ligation

Study type

Interventional

Funder types

Other

Identifiers

NCT03365089

2017P001237

Details and patient eligibility

About

Arteriovenous fistulas (AVFs) for hemodialysis often fail to become usable due to failure to mature (FTM). The most common cause is narrowing of the artery or vein (stenosis). Another potential cause is the presence of collateral or side branch veins that steal blood flow from the main fistula channel. Some believe that occluding these veins might help maturation of those failing AVFs. To evaluate if this actually works, patients with FTM will be randomly assigned to side branch vein ligation (or not), and rates of AVF maturation of the two groups will be compared.

Full description

Arteriovenous fistulas (AVFs) for hemodialysis often fail to become usable due to failure to mature (FTM). The most common cause is stenosis of the artery or vein. Another potential cause is the presence of collateral or side branch veins that steal blood flow from the main fistula channel. The utility of ligating these veins to improve maturation of those failing AVFs is controversial. To evaluate this, 35 patients presenting for fistulograms for evaluation of AVFs with FTM, found to have side branch veins will be prospectively enrolled. After management of stenoses (if present), they will be randomly assigned to ligation of the venous side branches or not. Maturation rates for each group will be prospectively assessed. For patients assigned to the control group who have persistent failure to mature, a cross-over intervention will be performed and side branch ligation will be offered.

Enrollment

35 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with upper extremity autogenous AVF presenting with FTM with evidence of collaterals on ultrasound and/or clinical exam.

Exclusion criteria

Age under 18 years
Pregnant women
Prior endovascular or surgical procedure in the fistula after its creation (with the exception of surgical superficialization or mobilization)
Clinical evidence of infection associated with the AVF
Uncorrectable coagulopathy (International Normalized Radio >2.5, platelet count <50.000/μL)
Absence of significant venous side branches on angiogram (defined as those that arise in the initial 10 cm, including the future cannulation zone, and have maximal diameter greater than or equal to one third of the widest diameter of the fistula's main venous channel in this segment).