Breast Cancer LymphedemaPLEDGE-RNCT05246592
Effect of the Axillary Lymphatic /Vein Reflux Ratio on Postoperative Upper Limb Edema and Dysfunction in Breast Cancer
An observational study of Breast Cancer Lymphedema, run by Xiangyun Zong at 3 sites in China.
Trial summary
The purpose of this study is to compare the difference in the incidence of upper limb edema and dysfunction between the Preponderant lymphatic reflux group (high ratio of axillary lymphatic reflux to axillary vein reflux) and the Preponderant venous reflux group (low ratio of axillary lymphatic reflux to axillary vein… Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Breast Cancer Lymphedema
- What is being tested?
- Branches Sparing and None Branches Sparing
- Type of treatment
- Surgery or procedure
- How many people
- 258 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jan 2022to 30 Jun 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients recruited in the PLEDGE study （NCT05120180）
Who may be able to join
- Age 18-69 years old,
- Regardless of gender,
- Breast masses were diagnosed by histology and pathology, stage II -III.
- Clinical palpation of axillary lymph nodes is positive, or
- Axillary lymph node puncture pathology is positive, or
- The multidisciplinary treatment cooperation group (MDT) recommends axillary lymph node dissection,
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- Good physical state score (0-1),
- No severe organ complications,
- No congenital or acquired diseases affecting the normal morphology and functional activities of the upper limbs,
- Informed consent, understanding and compliance with research requirements.
Who cannot join
- Pregnancy or lactation,
- Inflammatory breast cancer,
- Clinical findings of metastatic lesions,
- Sentinel lymph node biopsy was negative,
- History of upper limb or shoulder, chest, back trauma or surgery,
- Previous history of local radiotherapy,
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- History of other tumors,
- Vascular embolic disease,
- Those who are unable to comply with the clinical trial requirements for any reason.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200233
Shanghai Fengxian Central Hospital
Shanghai, 201499
About this study
Official title: Postoperative Upper Limb Edema and Dysfunction Generated by Axillary Nodes Excision Differs Due to the Ratio of Axillary Lymphatic and Axillary Vein Reflux in Breast Cancer Patients: a Prospective Cohort Study
The purpose of this study is to compare the difference in the incidence of upper limb edema and dysfunction between the Preponderant lymphatic reflux group (high ratio of axillary lymphatic reflux to axillary vein reflux) and the Preponderant venous reflux group (low ratio of axillary lymphatic reflux to axillary vein reflux).
- Conditions
- Breast Cancer Lymphedema
- Being tested
- Branches Sparing, None Branches Sparing
- Keywords
- Breast Cancer, Axillary Lymph Node Dissection, Post-mastectomy Lymphedema, Upper Limb Dysfunction, axillary lymphatic reflux, axillary vein reflux
- Medical subject headings
- Breast Cancer Lymphedema, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Branches SparingProcedure or surgery
The patients will undergo axillary lymph node dissection with preserved axillary vein branches
None Branches SparingProcedure or surgery
The patients will undergo axillary lymph node dissection without preserved axillary vein branches
| Study group | Role | What they receive |
|---|---|---|
| Preponderant lymphatic reflux group | high ratio of axillary lymphatic reflux to axillary vein reflux Receives: Procedure: Branches Sparing; Procedure: None Branches Sparing | |
| Preponderant venous reflux group | low ratio of axillary lymphatic reflux to axillary vein reflux Receives: Procedure: Branches Sparing; Procedure: None Branches Sparing |
What is being measured
The primary outcome is the main question the study is designed to answer.
short-term Incidence of lymphedema
Incidence of upper limb lymphedema on affected side at 1-, 6-, and 12-month after operation
Measured: 1-, 6-, and 12-month
short-term Incidence of dysfunction
Incidence of upper limb dysfunction on affected side at 1-, 6-, and 12-month after operation
Measured: 1-, 6-, and 12-month
Secondary outcomes (2)
long-term Incidence of lymphedema
Incidence of upper limb lymphedema on affected side 5 years after operation
Measured: 5 years
long-term Incidence of dysfunction
Incidence of upper limb dysfunction on affected side 5 years after operation
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start1 Jan 2022
- Primary completion1 Apr 2024
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 258 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Xiangyun Zong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiangyun Zong, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Investigators
- XIANGYUN ZONG, MD, PhD, Study chair, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246592
- Sponsor's protocol ID
- JTU-6H-20211230001
- Acronym
- PLEDGE-R
- Status last verified
- Sep 2026
- First submitted
- 9 Feb 2022
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Upper Limb Edema and Dysfunction Generated by Axillary Nodes Excision Differs Due to the Ratio of Axillary Lymphatic and Axillary Vein Reflux in Breast Cancer Patients: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05246592
- Acronym / sponsor ID
- PLEDGE-R / JTU-6H-20211230001
- Conditions
- Breast Cancer Lymphedema
- Keywords
- Breast Cancer, Axillary Lymph Node Dissection, Post-mastectomy Lymphedema, Upper Limb Dysfunction, axillary lymphatic reflux, axillary vein reflux
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Xiangyun ZongUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the difference in the incidence of upper limb edema and dysfunction between the Preponderant lymphatic reflux group (high ratio of axillary lymphatic reflux to axillary vein reflux) and the Preponderant venous reflux group (low ratio of axillary lymphatic reflux to axillary vein reflux).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preponderant lymphatic reflux group | – | Procedure: Branches Sparing, Procedure: None Branches Sparinghigh ratio of axillary lymphatic reflux to axillary vein reflux |
| Preponderant venous reflux group | – | Procedure: Branches Sparing, Procedure: None Branches Sparinglow ratio of axillary lymphatic reflux to axillary vein reflux |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients recruited in the PLEDGE study （NCT05120180）
Key inclusion criteria (10 listed)
- Age 18-69 years old,
- Regardless of gender,
- Breast masses were diagnosed by histology and pathology, stage II -III.
- Clinical palpation of axillary lymph nodes is positive, or
- Axillary lymph node puncture pathology is positive, or
Key exclusion criteria (9 listed)
- Pregnancy or lactation,
- Inflammatory breast cancer,
- Clinical findings of metastatic lesions,
- Sentinel lymph node biopsy was negative,
- History of upper limb or shoulder, chest, back trauma or surgery,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Branches SparingThe patients will undergo axillary lymph node dissection with preserved axillary vein branches | Procedure or surgery | Preponderant lymphatic reflux group, Preponderant venous reflux group |
| None Branches SparingThe patients will undergo axillary lymph node dissection without preserved axillary vein branches | Procedure or surgery | Preponderant lymphatic reflux group, Preponderant venous reflux group |
Primary outcome
short-term Incidence of lymphedema
Time frame: 1-, 6-, and 12-month
Incidence of upper limb lymphedema on affected side at 1-, 6-, and 12-month after operation
short-term Incidence of dysfunction
Time frame: 1-, 6-, and 12-month
Incidence of upper limb dysfunction on affected side at 1-, 6-, and 12-month after operation
2 secondary outcomes
long-term Incidence of lymphedema
Time frame: 5 years
long-term Incidence of dysfunction
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
XIANGYUN ZONG, MD, PhD study chair
Shanghai Jiao Tong University School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Lymphedema, run by Xiangyun Zong at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
short-term Incidence of lymphedema (time frame: 1-, 6-, and 12-month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.