Lymphatic Mapping for Sentinel Node Identification and Analysis

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The main objective of this study is to determine whether the first (sentinel) lymph nodes in the drainage pathway of colonic tumour can be detected at the time of surgery using a new technique. The detection method is to inject a fluorescent dye (indocyanine green) adjacent to the tumour. The dye will then be seen as it fluoresces in the light form the near infrared spectrum that can be used at the time of the laparoscopic (keyhole) surgery. An endoscope is placed in the colon (colonoscopy) during surgery and the tracer fluorescent agent is injected around the tumour. The mesentery in which the lymph nodes draining the tumour are located will then be examined by laparoscopy as it is expected that fluorescence will be identified within approximately 5 minutes of the injection. The first lymph node or nodes that take up the fluorescent dye will then be marked by placing a clip or a stitch by them. After the surgery has been completed and colon removed all lymph nodes can be examined microscopically by the pathologist, paying a particular attention to whether any tumour cells are present in the sentinel lymph nodes and whether the presence or the absence of tumour cells in that node accurately reflects the tumour status of the rest of the specimen.

If this pilot demonstrates that sentinel lymph nodes can be reliably detected, we have developed a technique which allows us to remove a small area (less than 5 cm) of the colon. Using this procedure should decrease complications following traditional surgery. We however also need a method that allows accurate assessment of the lymph nodes draining the tumour. This pilot trial will examine our ability to detect such 'sentinel' lymph nodes so that we can use their status (positive for cancer cells or negative) to determine whether a smaller operation such as full thickness localised excision is adequate treatment for the patient and that they can avoid a larger operation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imperial College London
• Collaborator: London North West Healthcare NHS Trust

Criteria

Inclusion Criteria:

1. Patients willing and able to give informed consent for participation in the study

2. Patients willing and able to comply with the study procedures

3. Male or Female, aged 18 years or above

4. Patients diagnosed with T1 or T2 colonic neoplasia on preoperative staging and require laparoscopic surgical excision

5. If female, a negative pregnancy test for women of childbearing potential prior to surgery

6. Patients who have clinically acceptable laboratory results pre-operatively with serum creatinine of <110 mg/dL

Exclusion Criteria:

1. Patients diagnosed with T3 or T4 disease on preoperative imaging

2. A patient who is pregnant, lactating or planning pregnancy during the course of the study

3. Allergy to any of the compounds being used for lymphatic mapping including Indocyanine green or sodium iodide

4. Patients with hyperthyroidism or those with thyroid adenomas

5. Patients with renal insufficiency (serum creatinine of >110 mg/dL)

6. Patients in whom the use of ICG is contraindicated including development of adverse events when previously or presently administered

7. Previous allergic reaction to shellfish