CRYPTIC Trial Version 1.0
Research type
Research Study
Full title
A feasibility multicentre randomised controlled trial on miCRosurgical immediate lYmPhaTIC reconstruction to reduce risk of lymphoedema (CRYPTIC trial)
IRAS ID
364508
Contact name
Muholan Kanapathy
Contact email
Sponsor organisation
Royal Free London NHS Foundation Trust
Duration of Study in the UK
2 years, 3 months, 30 days
Research summary
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 40–60 minutes to the procedure. The aim is to restore lymphatic drainage and reduce the risk of developing lymphoedema in the future.
In this trial, 60 patients who need ALNC will be invited to take part across three NHS hospitals. 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 two 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.
The main purpose of this feasibility study is to test whether this type of trial is practical and acceptable for patients and surgeons, 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.
REC name
North West - Preston Research Ethics Committee
REC reference
26/NW/0157
Date of REC Opinion
1 Jun 2026
REC opinion
Unfavourable Opinion