A Study on the accuracy and development of best practices using fluorescence for precision surgery in colorectal cancer

Completed

Conditions: Colorectal Cancer
Cancer

Registration Number: ISRCTN18431435

Lead Sponsor: niversity College London Hospitals

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 50

Inclusion Criteria

1. Benign or malignant colorectal disease that are being scheduled for a minimally invasive colorectal resection
2. 18 years of age and older
3. Either gender
4. Are able to have the procedure must be performed through a laparoscopic or robotic approach
5. Have a planned resection with hand sewn or stapled anastomosis
6. The colorectal procedure must be the primary procedure for the episode of care, and patients must participate in all follow-up appointments
7. Willing and able to give informed consent for participation in the study, adhere to protocol requirements and agree to participate in the study program

Exclusion Criteria

1. Subjects who undergo conversion to the open approach are excluded from the analysis, but conversion from robotic or single port to hand assisted or multi-port laparoscopic are included, with documentation
2. Pregnant or nursing
3. Another condition or general disability or infirmity that in the opinion of the investigator precludes further participation in the study.
4. Under 18 years of age
5. Incomplete medical records
6. Renal dysfunction with creatinine > 110 mg/dL
7. Known allergy or history of adverse reaction to ICG, iodine or iodine dyes
8. Intra-operative incidental finding of Stage IV cancer

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Accuracy of ICG fluorescent lymphangiography to create a sentinel lymph node map in colorectal cancer is measured during pathological analysis<br>2. Time to lymphatic drainage and sentinel node visualization with ICG … is measured using a fixed time from injection of ICG molecule<br>3. Accuracy of ICG fluorescent lymphangiography for determining appropriate resection margins in colon cancer cases is to be determined from this study. <br>

Secondary Outcome Measures