Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Contact information



Primary contact

Prof David Jayne


Contact details

University of Leeds & Leeds Teaching Hospitals NHS Trust
Section of Translational Anaesthesia & Surgery
Beckett Street
United Kingdom

Additional identifiers

EudraCT number

2012-002623-15 number

Protocol/serial number

14209; EME 11/100/24

Study information

Scientific title

GLiSten: Next generation intraoperative lymph node staging for stratified colon cancer surgery - development phase



Study hypothesis

The study is looking at the use of 5-aminolevulinic acid (5-ALA) in bowel cancer. 5-ALA will not be used to treat the cancer but used during the operation to detect the cancer along with any spread to lymph nodes that surround the bowel as it is preferentially taken up into cancer cells.

More details can be found at:
Protocol can be found at:

Ethics approval

NRES Committee London - South East, 20/03/2013, ref: 13/LO/0214

Study design

Non-randomised; Interventional; Design type: Treatment

Primary study design


Secondary study design

Non randomised study

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet


Topic: National Cancer Research Network; Subtopic: Colorectal Cancer; Disease: Colon


5-ALA will be given as a drink approximately 4 hours before surgery and it is thought that any cancer cells in the bowel and in the lymph nodes will glow red under a blue light.

The surgical specimen will be pathologically reviewed and the areas with confirmed cancer cells will be compared to areas that glowed red to see how accurately the substance (5-ALA) detects bowel cancer.

5-ALA has been used extensively before in other cancers, such as bladder cancer, brain tumours, and ovarian cancer. It has only been used before on a very small scale in colorectal cancer.

The study will first run as a Development phase to standardize the techniques, in two centres (Leeds and Dublin), recruiting at least 30 patients with positive lymph nodes. The trial will then expand to an Evaluation phase at approximately 8 centres recruiting 300 patients.

Follow Up Length: 1 month(s)

Intervention type



Not Applicable

Drug names

5-aminolevulinic acid

Primary outcome measure

Identification of the optimal dose for oral administration of 5-ALA for the accurate intra-operative; Timepoint(s): November 2014

Secondary outcome measures

1. Standardisation of preoperative CT reporting, with emphasis on lymph node evaluation
2. Standardisation of operative procedure including D3 lymphadenectomy
3. Optimisation and standardisation of fluorescence detection system
4. Standardisation of pathological lymph node mapping and step sectioning for in depth lymph node evaluation
5. Patient factors affecting the accuracy of 5-ALA fluorescence diagnosis
6. Safety

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Able to give informed consent and willing to follow trial protocol
2. Aged over 18
3. Patients with cancers of the right and sigmoid colon amenable to laparoscopic resection incorporating D3 lymphadenectomy, as agreed by MDT discussion following histopathological diagnosis and radiological staging. Where possible, the study population will be enriched with locally advanced colon cancers to obtain as much information as possible on 5-ALA Fluorescence diagnosi (FD) for lymph node metastases
4. Patients with distant metastatic disease will be eligible, provided laparoscopic resection of the cancer is part of routine clinical care
5. Fit for standard laparoscopic resection
6. American Society of Anesthesiologists (ASA) classification <= 3
7. Normal hepatic and renal function
7.1. Total bilirubin within normal institutional limits, AST/ALT < 2.5 X institutional upper limit of normal
7.2. Creatinine within normal institutional limits

Participant type


Age group




Target number of participants

Planned Sample Size: 52; UK Sample Size: 26

Participant exclusion criteria

1. Patients with cancers of the transverse and left colon (due to difficulty in defining D3 lymphadenectomy in these anatomical locations)
2. Past history of hypersensitivity reactions to 5-ALA or colorimetric dye
3. Acute or chronic porphyria or a family history
4. Patients with synchronous colonic or rectal cancer (but not benign polyps)
5. Patients with coexistent inflammatory bowel disease, such as Crohn’s disease, ulcerative colitis or active diverticulitis, which may influence the lymphatic uptake of 5-ALA
6. Pregnant (positive pregnancy test) or breast feeding. 5-ALA has unknown teratogenic and abortifacient effects.
7. Received an investigational medicinal product at any dose within 28 days before registration
8. Poorly controlled or serious medical or psychiatric illness that, in the Investigator’s opinion, is likely to interfere with participation and/or compliance in this clinical trial

Recruitment start date


Recruitment end date



Countries of recruitment

Ireland, United Kingdom

Trial participating centre

University of Leeds & Leeds Teaching Hospitals NHS Trust
United Kingdom

Sponsor information


University of Leeds (UK)

Sponsor details

c/o Neville Young
34 Hyde Terrace
United Kingdom

Sponsor type




Funder type


Funder name

Efficacy and Mechanism Evaluation Programme

Alternative name(s)

NIHR Efficacy and Mechanism Evaluation Programme, EME

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government


United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2016 results in:

Publication citations

Additional files

Editorial Notes

25/04/2019: Cancer Research UK lay results summary link added to Results (plain English). 24/01/2017: Publication reference added.