An interventional study of Nerve anastomosis in Breast Cancer, sponsored by Gangnam Severance Hospital. Not yet recruiting. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Gangnam Severance Hospital · Not applicable, Interventional, and Treatment
The purpose of this clinical trial is to demonstrate the superiority of sensory recovery following sensory nerve coaptation compared with no sensory nerve coaptation in patients undergoing nipple-sparing mastectomy with immediate breast reconstruction.
Breast sensation, including sensation of the nipple-areolar complex, may be diminished or lost following mastectomy because of injury to the sensory nerves supplying the breast skin and nipple-areolar complex. Sensory nerve coaptation may improve sensory recovery after surgery. This study will compare sensory recovery between patients who undergo sensory nerve coaptation and those who do not, with the aim of evaluating whether sensory nerve coaptation improves postoperative breast sensation.
Background and Scientific Rationale Breast Cancer and Nipple-Sparing Mastectomy Breast cancer is the most commonly diagnosed cancer among women in Korea, and its incidence has continued to increase. Compared with Western countries, breast cancer in Korea occurs relatively frequently in women in their 40s and 50s. Advances in breast cancer surgery and reconstruction have increasingly focused on improving cosmetic outcomes, patient satisfaction, and quality of life.
Nipple-sparing mastectomy (NSM), which preserves the nipple-areolar complex, is increasingly performed in appropriately selected patients undergoing mastectomy with immediate breast reconstruction. Previous studies have reported comparable survival outcomes and complication profiles between NSM and conventional mastectomy or skin-sparing mastectomy in selected patients.
Loss of Breast and Nipple-Areolar Sensation Despite advances in mastectomy techniques, breast reconstruction, implants, and acellular dermal matrices, postoperative sensory loss remains an important unresolved concern. Sensory impairment may occur because mastectomy can injure the medial and lateral intercostal nerves that provide sensation to the breast skin. Sensation in the nipple-areolar complex is also supplied by branches of the intercostal nerves, particularly the third through fifth intercostal nerves.
Previous studies have suggested that sensory nerve reconstruction, including coaptation of transected lateral intercostal nerves to the nipple-areolar complex using nerve allografts in selected procedures, may improve postoperative sensory recovery. However, prospective evaluation of sensory nerve coaptation during nipple-sparing mastectomy with immediate breast reconstruction remains limited.
Rationale for the Study Sensory nerve coaptation during nipple-sparing mastectomy with immediate breast reconstruction may improve postoperative sensory recovery. Improved sensation may contribute to greater patient satisfaction and quality of life. Given the proportion of breast cancer patients undergoing mastectomy with reconstruction at the participating institution, this approach may have potential clinical relevance for a substantial number of patients.
However, prospective evidence demonstrating the benefit of sensory nerve coaptation in this specific surgical setting is lacking. A randomized clinical trial is therefore needed to evaluate its effect on postoperative sensory recovery.
Study Objective The primary objective of this clinical trial is to demonstrate the superiority of sensory recovery following sensory nerve coaptation compared with no sensory nerve coaptation in patients undergoing nipple-sparing mastectomy with immediate breast reconstruction.
Potential Benefits and Risks Patients assigned to the sensory nerve coaptation group may experience improved postoperative sensory recovery. If the intervention is shown to be beneficial, the findings may help inform future surgical practice and potentially improve patient satisfaction and quality of life after breast cancer surgery.
Potential risks associated with sensory nerve coaptation include additional surgical complications and abnormal sensations. Previous retrospective studies have reported that complications and abnormal sensory symptoms associated with these procedures were uncommon. However, such risks cannot be excluded.
The study will compare sensory recovery between patients undergoing sensory nerve coaptation and those not undergoing the procedure to evaluate its potential benefits in the setting of nipple-sparing mastectomy with immediate breast reconstruction.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 110 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Gangnam Severance Hospital is the lead sponsor of 146 studies on the registry; 38 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will undergo nipple-sparing mastectomy with immediate breast reconstruction without sensory nerve coaptation.
Participants will undergo nipple-sparing mastectomy with immediate breast reconstruction and sensory nerve coaptation.
Procedure: Nerve anastomosis
For the Control Group (Cohort 1): Patients will undergo a nipple-sparing mastectomy and immediate implant-based breast reconstruction using the same ADM-wrapped silicone implant technique without nerve anastomosis. For the Nerve Anastomosis Group (Cohort 2): Patients will undergo a nipple-sparing mastectomy followed by immediate implant-based breast reconstruction. A breast pocket is created beneath the mastectomy flap, and the silicone implant is completely wrapped in an Acellular Dermal Matrix (ADM) to prevent capsular contracture before insertion into the pocket. During the mastectomy, the 3rd to 5th intercostal nerves located on the lateral side of the thoracic cage and the subareolar nerves are meticulously preserved to secure adequate length. Direct end-to-end nerve anastomosis is performed when possible. In cases where a nerve gap prevents direct tension-free closure, an acellular allograft nerve (MegaNerve prime®) is used to bridge the gap via end-to-end anastomosis.
Change in Nipple-Areolar Complex (NAC) Tactile Sensitivity Score
Measured using standardized tactile tests (e.g., Semmes-Weinstein monofilaments).
Time frame: Post-operative Month [예: 6,12,18,24,30,36 months]
Change in Breast Skin Tactile Sensitivity Score
Measured using standardized tactile tests across designated breast skin areas.
Time frame: Post-operative Month [예: 6,12,18,24,30,36 months]
Change in Nipple-Areolar Complex (NAC) Thermal Sensitivity Score
Measured using thermal sensitivity testing.
Time frame: Post-operative Month [예: 6,12,18,24,30,36 months]
Change in Breast Skin Thermal Sensitivity Score
Measured using thermal sensitivity testing.
Time frame: Post-operative Month [예: 6,12,18,24,30,36 months]
Patient-Reported Outcomes Using Breast-Q Reconstruction Module and 4 Subjective Skin Sensitivity Questions
Assessed via the Breast-Q questionnaire and an additional 4-item subjective questionnaire regarding skin sensation.
Time frame: Post-operative Month [예: 6,12,18,24,30,36 months]
Sensory Recovery Comparison According to the Number of Anastomosed Nerve Branches (1, 2, or 3)
Comparison of nerve recovery outcomes based on the number of successfully anastomosed nerve branches.
Time frame: Post-operative Month [예: 6,12,18,24,30,36 months]
Post-operative Complications
Incidence and severity of surgical complications.
Time frame: Post-operative Month [예: 36 months]
No study locations are listed for this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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