A multicenter, prospective controlled study on the efficacy and safety of robot-assisted, endoscopic-assisted or open axillary lymph node dissection for breast cancer

A multicenter, prospective, randomized controlled study on the efficacy and safety of robot-assisted versus traditional or laparoscopy-assisted axillary lymph node dissection in breast cancer

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500095675

Enrollment

Unknown

Registered

2025-01-10

Start date

2025-01-16

Completion date

Unknown

Last updated

2025-01-13

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

Conditions

breast cancer

Interventions

Robotic group :Robot-assisted axillary lymph node dissection

Endoscopic group :Endoscopic-assisted axillary lymph node dissection

Open surgery group:Open axillary lymph node dissection

Eligibility

Sex/Gender

Female

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Age: 18 - 80 years old; (2) Diagnosed as breast cancer by histopathological examination; (3) Patients with clinical stage N1 - N3. (4) Physical condition ECOG PS: 0 - 1; (5) Patients voluntarily signed the informed consent form.

Exclusion criteria

Exclusion criteria: (1) The image shows that the axillary lymph nodes invade the axillary blood vessels or nerves; (2) Distant metastasis is found in the auxiliary examination; (3) There are severe or unstable physical diseases, including diseases of the liver, kidney, gastrointestinal tract, cardiovascular system, respiratory system, endocrine system, nervous system, immune system or blood system, etc.

Design outcomes

Primary

Measure	Time frame
Postoperative range of motion of the shoulder joint;	—

Secondary

Measure	Time frame
Time of axillary lymph node dissection;Intraoperative blood loss;Postoperative drainage flow;Duration of axillary drainage ;Post-operation hospital stay;The number of lymph nodes obtained during the operation;Number of metastatic lymph nodes ;Postoperative complications;Local recurrence rate of the axilla;Distant metastasis rate;Postoperative pain;Upper limb function scale was used to evaluate after operation(DASH);Quality of life score;	—

Measure

Time frame

Time of axillary lymph node dissection;Intraoperative blood loss;Postoperative drainage flow;Duration of axillary drainage ;Post-operation hospital stay;The number of lymph nodes obtained during the operation;Number of metastatic lymph nodes ;Postoperative complications;Local recurrence rate of the axilla;Distant metastasis rate;Postoperative pain;Upper limb function scale was used to evaluate after operation(DASH);Quality of life score;

—

Countries

China

Contacts

Public ContactLi Haiyan

The Sixth Affiliated Hospital of Sun Yat-Sen University

lihy27@mail.sysu.edu.cn+86 158 1334 0604

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026