Collateral Ligation in Failing Fistulas

Not Applicable

• Conditions: Hemodialysis Access Failure
• Interventions: Procedure: Collateral vein ligation

• Registration Number: NCT03365089
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2017-11-21
• Study First Submitted QC: 2017-12-05
• Study First Posted: 2017-12-07
• Study Start: 2018-05-14
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-11
• Last Update Posted: 2018-12-13
• Primary Completion: 2019-12-31
• Study Completion: 2020-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Collateral vein ligation	Collateral vein ligation	Ligation of collateral veins under sonographic guidance

Primary Outcome Measures

Name	Time	Method
Fistula maturation rate	8 weeks after randomization	Proportion of patients with usable arteriovenous fistula at the end of the study (being able to deliver the prescribed dialysis dose 75% of the sessions in the first 4 weeks of use via 2 needles)

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States