A study to find out if early microsurgery to repair damaged lymph vessels can reduce arm swelling after lymph node removal surgery for cancer treatment
| ISRCTN | ISRCTN15511645 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15511645 |
| Integrated Research Application System (IRAS) | 375171 |
| Central Portfolio Management System (CPMS) | 58106 |
| Sponsor | The Royal Free Hospital |
| Funder | National Institute for Health and Care Research |
- Submission date
- 07/09/2026
- Registration date
- 13/10/2026
- Last edited
- 13/10/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Surgery for cancer sometimes requires removal of the lymph nodes in the armpit, known as axillary lymph node clearance (ALNC). While this is often necessary for cancer treatment, it carries a risk of causing lymphoedema, a long-term condition that results in painful and disabling swelling of the arm. Lymphoedema can have a major impact on quality of life and currently there are no proven ways of preventing it.
This study is testing whether it is possible to introduce a new surgical technique, called immediate lymphatic reconstruction (ILR), alongside standard cancer surgery. ILR involves reconnecting small lymphatic vessels to tiny veins in the armpit during the operation. This is done using microsurgery and adds around 60 minutes to the procedure. The aim is to restore lymphatic drainage and reduce the risk of developing lymphoedema in the future.
Who can participate?
Patients aged 18 years and over with breast cancer or skin cancer of the trunk who need ALNC
What does the study involve?
Participants will be randomly allocated by computer to one of two groups. One group will receive standard surgery (ALNC alone), while the other group will receive ALNC with ILR. All patients will be followed for up to 2 years. At each follow-up, doctors and nurses will assess the arms for swelling, carry out simple tests such as arm measurements and bioimpedance (a painless electrical measurement), and ask participants to complete questionnaires about wellbeing and quality of life. In some centres, an additional test called indocyanine green (ICG) lymphography may also be used.
What are the possible benefits and risks of participating?
The main purpose of this feasibility study is to test whether this type of trial is practical and to gather early safety data. If successful, the results will inform the design of a larger trial to properly test whether ILR prevents lymphoedema.
Where is the study run from?
The Royal Free Hospital (UK)
When is the study starting and how long is it expected to run for?
October 2026 to September 2029
Who is funding the study?
The National Institute for Health and Care Research (NIHR) (UK)
Who is the main contact?
1. Muholan Kanapathy, m.kanapathy@ucl.ac.uk, muholan.kanapathy@nhs.net
2. Naghmeh Naderi, naghmeh.naderi@nhs.net
Contact information
Principal investigator, Scientific, Public
Royal Free Hospital London NHS Foundation Trust
London
NW3 2QG
United Kingdom
| Phone | +44 (0)20 7794 0500 |
|---|---|
| muholan.kanapathy@nhs.net |
Principal investigator, Scientific, Public
Royal Free Hospital London NHS Foundation Trust
London
NW32QG
United Kingdom
| Phone | +44 (0)20 7794 0500 |
|---|---|
| naghmeh.naderi@nhs.net |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Prevention, Treatment |
| Scientific title | A feasibility multicentre randomised controlled trial on microsurgical immediate lymphatic reconstruction to reduce risk of lymphoedema |
| Study acronym | CRYPTIC |
| Study objectives | This study aims to evaluate the feasibility of performing a multicentre randomized controlled trial (RCT) on immediate lymphatic reconstruction in prevention of lymphoedema. |
| Ethics approval(s) |
Approved 07/09/2026, West of Scotland REC 4 (Research Ethics – Room 29, 2nd Floor Administration Building, Gartnavel Royal Hospital, 1055 Great Western Road, Glasgow, G12 0XH, United Kingdom; +44 (0)141 314 4485/0213; ggc.wosrec4@nhs.scot), ref: 26/WS/0121 |
| Health condition(s) or problem(s) studied | Patients with cancer requiring axillary lymph node clearance (ALNC) as part of their planned surgical treatment |
| Intervention | Randomisation will be performed on a 1:1 basis (ILR versus non-ILR (control)). Stratification by site will be applied to balance recruitment across the recruiting NHS hospitals. Participants will be deemed enrolled into the study once they have been randomised to either of the study arms. The assessor will be blinded to the allocation. The control group undergoes axillary lymph node clearance (ALNC) for breast cancer or skin cancer of the trunk. The intervention group undergoes ALNC and immediate lymphatic reconstruction. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 30/09/2029 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | All |
| Target sample size at registration | 50 |
| Key inclusion criteria | 1. Adults ≥18 years old 2. Diagnosis of breast cancer or skin cancer of the trunk requiring ALNC (with or without neoadjuvant or adjuvant systemic treatment) 3. Patient understands and is willing to consent, can comply with follow-up regime and able to respond to the questionnaires |
| Key exclusion criteria | 1. Skin cancer of the ipsilateral upper limb requiring surgical excision 2. Fungating axillary lymph node disease requiring soft tissue reconstruction 3. Inflammatory breast cancer 4. Previous history of upper limb cancer or lymphoedema 5. Prior ipsilateral axillary radiation 6. High risk for general anaesthesia (GA) or not fit for surgery (ASA classification >4) |
| Date of first enrolment | 01/10/2026 |
| Date of final enrolment | 31/03/2028 |
Locations
Countries of recruitment
- United Kingdom
- England
- Wales
Study participating centres
Pond Street
London
NW3 2QG
England
London
W6 8RF
England
London
NW1 2PG
England
Heol Maes Eglwys
Morriston
SA6 6NL
Wales
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
14/09/2026: Study's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
