None listed
Conditions
Brief summary
Endoscopic surgical resection for early cancer of the oesophagus (involving insertion of a camera via the mouth rather than open surgery) is a widely accepted technique, allowing for complete removal of pre-cancerous tissue in this region. However this technique can lead to a narrowing or tighening of the oesophagus which may lead to difficulty swallowing and subsequent malnutrition. This study aims to investigate what effect injecting autologous (from your own body) fat cells into the surgical site has on the occurrence of oesophageal narrowing post-surgery. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with Squamous cell oesophageal cancer, Barrett’s oesophagus with dysplasia or oesophageal intramucosal cancer and you are scheduled to undergo a surgical resection to remove cancerous tissue. Study details All participants who choose to enrol in this study will have approximately 20mls of fat tissue taken (as one sample) harvested from them prior to the procedure. Participants will then undergo the endoscopic surgery as planned, and these fat samples (following cleansing, approximately 2 - 5mls will be re-injected) will then be injected directly into the oesophageal tissue prior to the end of the surgery. The study investigators will follow up all participants for 3 months post-surgery to determine any adverse events or complications that may arise after the procedure, and will also assess swallowing ability and cancer recurrence. It is hoped this research will demonstrate that it is safe and technically feasible to inject autologous fat cells during an endoscopic oesophageal resection procedure. If this technique is found to be safe and shows signs of reducing oesophageal narrowing, a larger randomised study may be conducted at a later date which could provide a better quality of life for future oesophageal cancer patients.
Interventions
Injection of autologous fat after oesophageal endoscopic resection.
Fat will be harvested at the same time or before endoscopic resection, from the abdomen or flank, under a general anaesthetic (with prophylactic antibiotics). The lipoaspirate is decanted to eliminate cellular debris, acellular oil and any excess of infiltrated solution. Prepared fat will be injected immediately after endoscopic resection completed, volume of 2 - 5 ml dependent on size of resection. A member of the research tea
Injection of autologous fat after oesophageal endoscopic resection. Fat will be harvested at the same time or before endoscopic resection, from the abdomen or flank, under a general anaesthetic (with prophylactic antibiotics). The lipoaspirate is decanted to eliminate cellular debris, acellular oil and any excess of infiltrated solution. Prepared fat will be injected immediately after endoscopic resection completed, volume of 2 - 5 ml dependent on size of resection. A member of the research team (plastic surgeon) will harvest the fat and be responsible for injecting the fat where required following endoscopic procedure. It is anticipated that the intervention will add 15 - 20 minutes to the time of the overall procedure. The intervention will be performed by the interventional endoscopist and plastic surgeon, adherence will be monitored by auditing operation reports
Sponsors
St Vincent's Hospital Melbourne
Study design
Allocation
Non-randomised trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1.Aged 18 years old and over 2.Medically fit for anaesthesia 3.Squamous cell or Barrett’s oesophagus with dysplasia or intramucosal cancer 4.75% or greater oesophageal circumferential resection either via Endoscopic Mucosal Resection (EMR) or Endoscopic Submucosal Resection (ESD) 5.Informed consent obtained from the patient or legal representative
Exclusion criteria
1. Pregnant at enrolment 2. Unable to obtain informed consent from the patient or legal representative 3. Medically unfit for anaesthesia 4. Current smokers 5. Previous radiotherapy to the involved oesophagus 6. Irreversible coagulopathy: INR >1.5 7. Irreversible thrombocytopenia: platelet count <50 x 109/L, thrombocytopenia confirmed by manual count 8. Dual antiplatelet therapy or therapeutic anticoagulation that cannot be withheld for the procedure 9. Presence of oesophageal varices 10. Immunocompromised
Outcome results
None listed