5-ALA in bowel cancer surgery
| ISRCTN | ISRCTN79949827 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79949827 |
| EudraCT/CTIS number | 2012-002623-15 |
| Secondary identifying numbers | 14209; EME 11/100/24 |
- Submission date
- 04/04/2013
- Registration date
- 04/04/2013
- Last edited
- 25/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Prof David Jayne
Scientific
Scientific
University of Leeds & Leeds Teaching Hospitals NHS Trust
Section of Translational Anaesthesia & Surgery
Beckett Street
Leeds
LS9 7TF
United Kingdom
| d.g.jayne@leeds.ac.uk |
Study information
| Study design | Non-randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | GLiSten: Next generation intraoperative lymph node staging for stratified colon cancer surgery - development phase |
| Study acronym | GLiSten |
| Study objectives | 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: https://www.journalslibrary.nihr.ac.uk/programmes/eme/1110024/#/ Protocol can be found at: https://njl-admin.nihr.ac.uk/document/download/2005810 |
| Ethics approval(s) | NRES Committee London - South East, 20/03/2013, ref: 13/LO/0214 |
| Health condition(s) or problem(s) studied | Topic: National Cancer Research Network; Subtopic: Colorectal Cancer; Disease: Colon |
| Intervention | 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 | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/06/2013 |
| Completion date | 30/11/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 52; UK Sample Size: 26 |
| Key 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 |
| Key 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 Crohns 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 Investigators opinion, is likely to interfere with participation and/or compliance in this clinical trial |
| Date of first enrolment | 01/06/2013 |
| Date of final enrolment | 30/11/2014 |
Locations
Countries of recruitment
- England
- Ireland
- United Kingdom
Study participating centre
University of Leeds & Leeds Teaching Hospitals NHS Trust
Leeds
LS9 7TF
United Kingdom
LS9 7TF
United Kingdom
Sponsor information
University of Leeds (UK)
University/education
University/education
c/o Neville Young, 34 Hyde Terrace
Leeds
LS2 9LN
England
United Kingdom
| Website | http://www.leeds.ac.uk |
|---|---|
"ROR" |
https://ror.org/024mrxd33 |
Funders
Funder type
Government
Efficacy and Mechanism Evaluation Programme
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- NIHR Efficacy and Mechanism Evaluation Programme, EME
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| Results article | results | 01/08/2016 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
25/04/2019: Cancer Research UK lay results summary link added to Results (plain English).
24/01/2017: Publication reference added.
