Sentinel. Ambulatory. Oral Cavity. Oropharynx (S.A.C.O)
This study, called Sentinel. Ambulatory. Oral Cavity. Oropharynx (S.A.C.O), is for people with early-stage mouth or throat cancer. Doctors usually operate on the main tumour and lymph nodes in the neck. This study investigates if a specific type of surgery, which involves looking for 'guard' lymph nodes, can be done as a day case. This means you wouldn't need to stay in the hospital overnight. The main aim is to see how many people need to be admitted or re-admitted to the hospital shortly after this day surgery. Researchers are also checking how patients feel about this approach, any problems that might occur, and the cost.
At a glance
What is this study about?
This study is about making treatment for certain early mouth and throat cancers easier for patients. When you have an early-stage cancer in your mouth or the back of your throat (what doctors call T1-N0 or T2-N0 oral cavity or oropharynx cancer), surgery is a common treatment. This usually involves removing the main tumour and sometimes checking the lymph nodes in your neck.
Traditionally, these surgeries can mean a longer hospital stay. However, doctors are now looking at a technique called 'sentinel lymph node' surgery. This involves finding tiny 'guard' lymph nodes that are the first place cancer cells might spread. If these 'guard' nodes are clear, it often means the cancer hasn't spread further. Because this approach is less invasive, doctors believe many patients might be able to go home on the same day as their surgery, rather than staying overnight.
This study wants to find out if doing this surgery as a day case is safe and practical. They'll be checking if patients need to stay in hospital unexpectedly or come back within 10 days of their surgery. They'll also be looking at how patients feel about day surgery, any problems that might come up, and how this way of doing things compares in terms of cost and patient well-being.
Key takeaways
- This study is for early mouth or throat cancer.
- It explores if a specific surgery can be done as a day case.
- A special scan helps find 'guard' lymph nodes before surgery.
- The main goal is to see how many patients can go home the same day.
- It also checks patient experience, problems, and costs.
- You'll need follow-up appointments for up to two years.
Who may be eligible?
To join this study, you need to be an adult, aged 18 or older, and be covered by a healthcare system. You should have a specific type of early-stage mouth or throat cancer confirmed by a recent biopsy. Your medical team must also agree that the cancer can be removed with surgery, and you should be generally well enough for day surgery activities.
There are also some reasons why you wouldn't be able to join. For example, if you have other cancers being treated, or if your cancer isn't the specific type they are looking for. You also can't participate if you're pregnant, have certain allergies to the medicines used in the scans, or if you can't commit to follow-up check-ups for two years.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Am I 18 years old or older?
- Do I have early-stage mouth or throat cancer?
- Has my doctor said my cancer can be removed with surgery?
- Am I generally well enough for day surgery?
- Am I able to attend follow-up appointments for up to two years?
- Am I currently pregnant or have any severe allergies to medical dyes?
What does participation involve?
If you decide to take part, you'll first have a special scan called a lymphoscintigraphy the day before your surgery (Day-1). This involves a small injection of a safe, temporary dye near your tumour to help doctors find your 'guard' lymph nodes. This scan is usually done as an outpatient procedure, meaning you go home afterward. On the day of your surgery (Day 0), you'll come to the hospital early in the morning for your outpatient surgery. You'll meet with the anaesthetist before your procedure, which will be done under general anaesthesia. The surgeon will remove your tumour and the 'guard' lymph nodes. The goal is for you to go home the same day. The study will then follow your progress for the first month after surgery, checking for any complications and asking about your quality of life.
Potential risks and benefits
Locations (1)
- Gui de Chauliac Hospital, ENT Department 80 rue Augustin FlicheVerified postcodeMontpellier, France· Recruiting
Common questions
What is 'day case' surgery?
Day case surgery means you have your operation and go home on the very same day, without needing to stay overnight in the hospital.
What are 'guard' lymph nodes?
'Guard' lymph nodes (sentinel lymph nodes) are the first lymph nodes that drain from the cancer. Doctors check these to see if cancer cells have started to spread.
Will I be awake during the surgery?
No, the surgery will be done under general anaesthesia, meaning you will be asleep and won't feel anything during the procedure.
How long will I be followed after the surgery?
The main part of the study looks at your recovery for the first month after surgery, but you will typically have follow-up appointments with your medical team for up to two years.
Is this study suitable for all types of mouth and throat cancer?
No, this study is specifically for early-stage mouth or throat cancers (T1-N0 or T2-N0). Your doctor can tell you if your cancer fits this description.
How to find out more
Renaud GARREL, ENT
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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