A Pilot Study Assessing the Effect of Lymphaticovenous Micro-Anastomosis in the Treatment of Postmastectomy Lymphedema

• Sponsor: University of Arkansas (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02020837
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arm: 1
• Duration (Months): 34
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This study will assess the impact of lymphaticovenous microanastomosis in volume reduction of postmastectomy upper extremity lymphedema. We hypothesize that multiple lymphaticovenous micro-anastomosis in the distal arm will result in the reduction of volume and improvement in quality of life of patients with post-mastectomy lymphedema

Condition or Disease	Intervention/Treatment	Phase
Lymphedema; Post Mastectomy	Procedure: Lymphaticovenous Micro-Anastomosis	Early Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: A lymphatic diversion with lymphaticovenous microanastomosis will be performed.A lymphatic diversion with lymphaticovenous microanastomosis will be performed.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Study Assessing the Effect of Lymphaticovenous Micro-Anastomosis in the Treatment of Postmastectomy Lymphedema
• Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Dec 3, 2015
• Actual Study Completion Date: Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lymphaticovenous Micro-Anastomosis	Procedure: Lymphaticovenous Micro-Anastomosis

Outcome Measures

Primary Outcome Measures

1. Changes Relative to Baseline in the Volume of the Affected Limb at 3 and 6 Months From Surgery [3 and 6 months from surgery]

   Lymphatic Volumetric Assessment. Evaluation of the volumetric change, relative to baseline measurement, in the volume of the affected limb at 3 and 6 months from the procedure.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject is 18-70 years of age

• Subject is Stage II-IV unilateral lymphedema

Exclusion Criteria:

• Subject is less than 6 months from completion of cancer treatment

• Subject has allergic reaction to the lymphatic contrast agent (Indocyanine Blue)

• Subject is medically unfit for the procedure

• Subject is unable to complete the follow-up visits

• Women with a positive urine pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence.

• Subject has bilateral lymphedema

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205

Sponsors and Collaborators

• University of Arkansas

Investigators

• Principal Investigator: Mauricio Moreno, MD, University of Arkansas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Arkansas
• ClinicalTrials.gov Identifier: NCT02020837
• Other Study ID Numbers: 202676
• First Posted: Dec 25, 2013
• Last Update Posted: Jun 27, 2018
• Last Verified: Apr 1, 2018

• Additional relevant MeSH terms: Lymphedema; Breast Cancer Lymphedema

Study Results

Participant Flow

Arm/Group Title	Lymphaticovenous Micro-Anastomosis
Arm/Group Description	Lymphaticovenous Micro-Anastomosis
Period Title: Overall Study
STARTED	2
COMPLETED	2
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Lymphaticovenous Micro-Anastomosis
Arm/Group Description	Lymphaticovenous Micro-Anastomosis
Overall Participants	2
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	0 0%
>=65 years	2 100%
Sex: Female, Male (Count of Participants)
Female	2 100%
Male	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	2 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Count of Participants (Count of Participants)
Count of Participants [Participants]	2 100%

Outcome Measures

1. Primary Outcome

Title	Changes Relative to Baseline in the Volume of the Affected Limb at 3 and 6 Months From Surgery
Description	Lymphatic Volumetric Assessment. Evaluation of the volumetric change, relative to baseline measurement, in the volume of the affected limb at 3 and 6 months from the procedure.
Time Frame	3 and 6 months from surgery

Outcome Measure Data

Analysis Population Description

Early termination leading to small numbers of subjects.Outcome measures not computed because data would not be statistically relevant.

Arm/Group Title	Lymphaticovenous Micro-Anastomosis
Arm/Group Description	Lymphaticovenous Micro-Anastomosis
Measure Participants	0

Adverse Events

Time Frame	6 months
Arm/Group Title	Lymphaticovenous Micro-Anastomosis
Arm/Group Description	Lymphaticovenous Micro-Anastomosis
All Cause Mortality
	Lymphaticovenous Micro-Anastomosis
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Serious Adverse Events
	Lymphaticovenous Micro-Anastomosis
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Other (Not Including Serious) Adverse Events
	Lymphaticovenous Micro-Anastomosis
	Affected / at Risk (%)	# Events
Total	0/2 (0%)

Limitations/Caveats

Early termination leading to small numbers of subjects. Outcome measures not computed because data would not be statistically relevant.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.