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The clinical relevance of an armpit dissection with sparing of the nodes of the upper extrimity.

The clinical relevance of axillary reverse mapping: A multicenter randomised controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28839
Enrollment
280
Registered
2012-11-08
Start date
2013-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer, Axillary lymph node dissection, Breast cancer related lymphedema, Axillary reverse mapping

Interventions

A standard ALND compared with a limited and more tailor-made axillary lymph node dissecion, based on the ARM technique.

Sponsors

none
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Female patient aged 18 years and over presenting in one of the participating hospitals with the diagnosis invasive breast cancer and an indication for a complementary ALND based on a positive SLN are eligible for an ALND-ARM procedure. The indication for a complementary ALND will be made in a multidisciplinary team including an oncologic surgeon, medical oncologist, pathologist, radiologist and a radiotherapist.

Exclusion criteria

Exclusion criteria: Primary ALND based on a clinical positive axilla, a contra-indication for SLNB, a history of (breast) cancer, an adverse event during the previous SLNB and pregnancy will be excluded from participation of the RCT.

Design outcomes

Primary

MeasureTime frame
Lymphedema of the upper extrimity.

Secondary

MeasureTime frame
The secondary outcome measurements include other postoperative complications (pain, paresthesia, numbness and loss of shoulder mobility), quality of live and axillary recurrence ratio.

Contacts

Public ContactPaul D. Gobardhan

Department of Surgery Amphia hospital Breda

PGobardhan@amphia.nl+31 (0)76 5951000

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)