A study looking into finding the first lymph nodes a cancer may spread to in people having surgery for cancer of the food pipe
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
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Status:
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This study is looking to see if a keyhole operation called laparoscopy can help find the first lymph nodes that a cancer cell will travel to before it spreads around the body. These first lymph nodes are called 
Lymph nodes drain fluid from all tissues of the body including the food pipe (oesophagus). Cancer cells can spread to these lymph nodes. When you have surgery to remove cancer of the food pipe (oesophagectomy), your surgeon will also remove these lymph nodes. But the lymph nodes do not always contain cancer cells. If the sentinel lymph nodes are clear of cancer then the other lymph nodes should also be clear. So they might not always need to be removed.
Researchers in this study are looking at a way of checking the sentinel nodes. They will inject a radioactive tracer close to the cancer, allowing it to travel to the lymph nodes. They will then use a special keyhole gamma probe to show up the first lymph nodes reached. If a keyhole () technique to find and test the sentinel lymph nodes is accurate, it could be used in future to reduce the amount of surgery you need to remove lymph nodes, reducing the risks that come with it. It could also help doctors decide if keyhole surgery to remove the cancer is possible, and if using endoscopy to remove very early types of adenocarcinoma is a reliable option in some people.
You will not get any direct benefit from taking part in this study, and it will not change your treatment plan in any way. But the results of the study will be used to help people with cancer in the future.
Who can enter
You may be able to enter this study if you are being looked after by cancer specialists at the Royal Victoria Infirmary, Newcastle upon Tyne and
- You have cancer of the food pipe that started in the gland cells (adenocarcinoma of the food pipe)
- Your cancer is in the lower third of your food pipe, or where your food pipe meets your stomach (gastro oesophageal junction)
- You are due to have surgery aimed at curing your cancer
You cannot enter this study if
- The aim of any treatment you are having is to control symptoms rather than to cure your cancer
- You would not be suitable to have a keyhole procedure called a laparoscopy
Trial design
This study will recruit 40 people. It will not affect the surgery (oesophagectomy) already planned for you.
For the study, after you have had your for your planned oesophagectomy, you have an endoscopy to inject a radioactive tracer around your cancer. An endoscopy is where a small camera is put down your throat and into your food pipe. The doctor can see inside the food pipe by looking at pictures sent from the camera to a video screen. The team will then make some tiny (keyhole) cuts in your skin and through these pass a small camera, instruments and a probe. These are to identify the first lymph nodes that take up the tracer – the sentinel nodes. The rest of your surgery will then continue as planned to remove the cancer and all lymph nodes.
If you are due to have a laparoscopy to see how far the cancer has grown (the stage of your cancer) before your oesophagectomy, the team would like to carry out the same procedure, again under general anaesthetic. But instead of removing the sentinel lymph nodes, they would mark these nodes with a stitch. They would then repeat this procedure when you come back for your oesophagectomy, this time removing the sentinel nodes.
The team will ask people having a staging laparoscopy if they would also have a scan called a scintigram to help map out the lymph nodes before their laparoscopy. You would have the endoscopy first to inject the tracer around your cancer, then have the scintigram, before your staging laparoscopy. If you are in this group you will have some medication to relax you () before your endoscopy, and a general anaesthetic before your laparoscopy. The team hope that 10 people will agree to this extra scan.
The team will video record the endoscopy and keyhole operating technique, so that others can learn it for future use. No one will be able to tell that it is you in the recording.
Hospital visits
You will have the study procedures when you are already at the hospital for your staging laparoscopy or your surgery to remove your food pipe (oesophagectomy). The study procedure will add about 30 minutes to your operation. But you will not need to stay in hospital any longer than you were going to anyway.
Side effects
There is a low risk of causing a small hole in the food pipe (perforation), or of bleeding from the endoscopy. Compared to the surgery you are already having, the extra risks from the keyhole part of the study are small.
The dose of radiation being used is very small, and any risk from this is smaller than that of the radiation you would have from scans as part of your routine cancer care.
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Professor S M Griffin
Supported by
BUPA Foundation
National Institute for Health Research Cancer Research Network (NCRN)
Royal College of Surgeons of England
The Newcastle upon Tyne Hospitals NHS Foundation Trust
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
