None listed
Conditions
Brief summary
Who is it for? This study is intended for patients undergoing an endoscopic resection procedure (Endosocpic Mucosal Resection, EMR or Endoscopic Submucosal Dissection, ESD) for dysplasia or early cancer in the oesophagus. When a resection involves >/= 75% of the oesophageal lumen, the chance of a stricture and difficulty swallowing can approach 100% Study details: The aim is to assess whether the injection of this fat helps prevent the extent of these strictures Eligible patients undergoing this procedure have a portion of fat removed by liposuction from another part of their body and this fat is then injected into the defect after the resection takes place. There is no randomisation involved and the study is open (non-blinded). Follow up involves checking on swallowing and endoscopies to assess stricture rates (this is part of routine care) There are several things we do to try and prevent strictures after these procedures, including repeated gastroscopies and stretching of the narrowed portion of the oesophagus (food pipe), known as dilation, as well as using steroids either injected directly into the oesophagus (food pipe) at the site where the abnormal tissue was removed or in tablet form, to reduce the inflammation that leads to the narrowing forming. We would like to find a safer, more effective way to prevent the narrowing in the oesophagus (food pipe) from forming after this procedure, or to reduce the severity of the narrowing that develops. Recent studies have shown that injecting a small amount of your own fat into areas of inflammation and scarring in the body may improve healing. This has been looked at in healing tissue openings around the anus, and in healing after patients undergo plastic surgery. It has not been looked at in the oesophagus before and we hope we can develop strategies to help our patients by reducing the amount of stricture formation after oeosphageal endoscopic resection.
Interventions
1. patients in total with either squamous cell or Barrett’s oesophagus associated dysplasia or intramucosal cancer (T1a) who require 75% or greater circumferential endoscopic resection will be enrolled.
2. Endoscopic resection will then be performed as per standard Endoscopic Mucosal Resection (EMR) and Endoscopic Submucosal Dissection (ESD) technique. The total duration of resection varies from approximately 1 -2 hours and will differ with every patient.
3. Fat harvesting procedure and prepar
1. patients in total with either squamous cell or Barrett’s oesophagus associated dysplasia or intramucosal cancer (T1a) who require 75% or greater circumferential endoscopic resection will be enrolled. 2. Endoscopic resection will then be performed as per standard Endoscopic Mucosal Resection (EMR) and Endoscopic Submucosal Dissection (ESD) technique. The total duration of resection varies from approximately 1 -2 hours and will differ with every patient. 3. Fat harvesting procedure and preparation performed - Fat harvesting from appropriate site by plastic surgeon 4. Injection of autologous fat after endoscopic resection - this involves decanting harvested fat into a syringe then injecting it endoscopically into the ESD or EMR defect. - duration of procedure for hat harvesting and injection typically adds 30 mins to the resection time. - occurs once only 5. Intraprocedural antibiotics cephazolin 1gram and metronidazole 500mg both intravenously There is no routine monitoring of adherence or fidelity as this is not required, the intervention occurs intraprocedurally and thereafter all clinical outcomes are assessed at outpatient visits/ at routine endoscopy as below. Patients receive reminders for their upcoming appointments.
Sponsors
St Vincent's Public Hospital Melbourne
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
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 EMR or ESD 5. Informed consent obtained from the patient or legal representative
Exclusion criteria
1. Aged under 18 years old 2. Pregnant at enrolment 3. Unable to obtain informed consent from the patient or legal representative 4. Medically unfit for anaesthesia 5. Current smokers 6. Previous radiotherapy to the involved oesophagus 7. Irreversible coagulopathy: INR >1.5 8. Irreversible thrombocytopenia: platelet count <50 x 109/L, thrombocytopenia confirmed by manual count 9. Dual antiplatelet therapy or therapeutic anticoagulation that cannot be withheld for the procedure 10. Presence of oesophageal varices 11. Immunocompromised
Outcome results
None listed