5-ALA in bowel cancer surgery

Not Applicable

Completed

• Conditions: Subtopic: Colorectal Cancer; Malignant neoplasm of colon; Topic: National Cancer Research Network; Disease: Colon; Cancer

• Registration Number: ISRCTN79949827
• Lead Sponsor: niversity of Leeds (UK)

Brief Summary

2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27536753

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-04
• Study Completion: 2014-11-30
• Last Update Posted: 13 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 52

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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