Clinical trial NCT03365089: Collateral Ligation in Failing Fistulas
Official title: Prospective Randomized Evaluation of the Effect of Ligation of Venous Side Branches in Dialysis Arteriovenous Fistulas Presenting With Failure to Mature
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemodialysis Access Failure
Keywords: Hemodialysis fistula
Failure to mature
Collateral vein
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-12-07
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Fistula maturation rate
timeFrame: 8 weeks after randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Zubin Irani, MD
role: PRINCIPAL_INVESTIGATOR
References:
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