Lymphaticovenous Anastomosis as Treatment for Lymphedema

NCT05441943 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-03-05

No results posted yet for this study

Summary

The primary aim of this study is to investigate and test whether the use of combined indocyanine green (ICG) lymphography and ultra high frequency ultrasonography can correctly identify lymphatic vessels and venoles in close proximity to each other, for identification prior to lymphovenous anastomosis (LVA) surgery.

Conditions

  • Breast Cancer Lymphedema
  • Secondary Lymphedema
  • Iatrogenic Lymphedema
  • Lymphedema
  • Lymphedema of Upper Limb
  • Lymphedema Arm
  • Lymphedema, Breast Cancer
  • Breast Neoplasm
  • Neoplasms
  • Breast Cancer
  • Breast Diseases
  • Lymphatic Diseases
  • Skin Diseases
  • Postoperative Complications
  • Pathologic Processes
  • Anastomose
  • Surgery
  • Surgical; Lymphedema, Postmastectomy
  • Postmastectomy Lymphedema
  • Postmastectomy Lymphedema Syndrome Left Upper Limb
  • Postmastectomy Lymphedema Syndrome Right Upper Limb
  • Postmastectomy Lymphedema Syndrome

Interventions

PROCEDURE

Lymphovenous anastomosis

Pre-operative planning prior to lymphovenous anastomosis using ICG lymphography and ultra high frequency ultrasound for mapping of applicable vessels. During surgery, mapped vessels are freely dissected and anastomosed.

Sponsors & Collaborators

  • Danish Cancer Society

    collaborator OTHER
  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Caroline Lilja, MD · Department of Plastic Surgery at Odense University Hospital

  • Jens Ahm Sørensen, MD, Prof, PhD · Department of Plastic Surgery at Odense University Hospital

  • Jørn Bo Thomsen, MD, Prof, PhD · Department of Plastic Surgery at Odense University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-11
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05441943 on ClinicalTrials.gov