Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001249741p
Ethics application status
Submitted, not yet approved
Date submitted
19/07/2022
Date registered
16/09/2022
Date last updated
16/09/2022
Date data sharing statement initially provided
16/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the impact of autologous fat grafting on the risk of oesophageal strictures post endoscopic resection: a pilot study
Scientific title
Investigating the impact of autologous fat grafting on the risk of oesophageal strictures post endoscopic resection: a pilot study
Secondary ID [1] 307619 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Squamous cell oesophageal dysplasia 327097 0
Barrett’s oesophagus with dysplasia 327259 0
intramucosal oesophageal cancer 327260 0
Condition category
Condition code
Oral and Gastrointestinal 324243 324243 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 324395 324395 0 0
Surgical techniques
Cancer 324396 324396 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 324066 0
Treatment: Other
Intervention code [2] 324181 0
Treatment: Surgery
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332064 0
Safety
Measurement of intra or post procedural complications at regular intervals up to 30 days post procedure. Possible side effects -
- bruising, swelling at site of fat aspiration
-post procedure stricture formation resulting in difficulty swallowing, weight loss
Assessment of safety outcomes
- physical assessment post procedure - signs and symptoms of infection
- assessment of post procedure dysphagia using standard clinical assessment tools (dysphagia score, measurement of stricture development (luminal calibre)
- count number of unplanned endoscopic dilation and total number of endoscopic dilations at 4 weeks and 3 months post procedure.
Timepoint [1] 332064 0
one day, 1 week, 2 week 4 week 3 month post procedure
Primary outcome [2] 332204 0
technical efficacy of procedure - surgeon review after each procedure - time of intervention, any difficulties encountered during procedure, immediately post procedure.
Timepoint [2] 332204 0
post procedure review and evaluation of all 10 (pilot) patients
intra-procedure - Procedure duration (minutes): Fat harvesting, endoscopic resection, fat grafting, total anaesthetic time.
immediately post-procedure - physical examination
Secondary outcome [1] 412044 0
Rate of post-resection dysphagia
Assessed by research team questioning participant regarding difficulty swallowing and applying the dysphagia score
- 0 = able to eat normal diet/no dysphagia
- 1 = able to swallow some solid foods
- 2 = able to swallow only semi solid foods
- 3 = able to swallow liquids only
- 4 = unable to swallow anything









Timepoint [1] 412044 0
2 weeks, 4 weeks and 3 months post procedure
Secondary outcome [2] 412527 0
Degree of endoscopic stricture formation
Assessed by clinical review and observation during gastroscopy
Timepoint [2] 412527 0
2 weeks, 4 weeks, 3 months post procedure
Secondary outcome [3] 412529 0
Degree of neo-squamous re-epithelialisation of resection defect
Assessed by clinical review and observation during gastroscopy using (scale of 1-5 from none to complete neo-squamous re-epithelialisation)
Timepoint [3] 412529 0
4 weeks and 3 months post procedure

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/09/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 311883 0
Hospital
Name [1] 311883 0
St Vincent's Hospital Melbourne
Country [1] 311883 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
41 Victoria Parade, Fitzroy, 3065, Victoria, Australia.
Country
Australia
Secondary sponsor category [1] 313362 0
None
Name [1] 313362 0
Address [1] 313362 0
Country [1] 313362 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311318 0
St Vincent's Hospital Research Ethics Committee
Ethics committee address [1] 311318 0
41 Victoria Parade, Fitzroy 3065, Victoria, Australia
Ethics committee country [1] 311318 0
Australia
Date submitted for ethics approval [1] 311318 0
25/07/2022
Approval date [1] 311318 0
Ethics approval number [1] 311318 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120694 0
A/Prof Bronte Holt
Address 120694 0
St Vincent's Hospital (Melbourne)
Gastroenterology Department
41 Victoria Parade, Fitzroy, 3065, Victoria, Australia.
Country 120694 0
Australia
Phone 120694 0
+61 3 9231 3580
Fax 120694 0
Email 120694 0
bronteholt@gmail.com
Contact person for public queries
Name 120695 0
Dr Tony He
Address 120695 0
St Vincent's Hospital (Melbourne)
Gastroenterology Department
41 Victoria Parade, Fitzroy, 3065, Victoria, Australia
Country 120695 0
Australia
Phone 120695 0
+61 3 92312211
Fax 120695 0
Email 120695 0
tonyhe.714@gmail.com
Contact person for scientific queries
Name 120696 0
Dr Tony He
Address 120696 0
Gastroenterology Department,
St Vincent's Hospital (Melbourne)
41 Victoria Parade, Fitzroy, 3065, Victoria, Australia
Country 120696 0
Australia
Phone 120696 0
+61 3 92312211
Fax 120696 0
Email 120696 0
tonyhe.714@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Collected data will only be used for publication in peer review journals or presented at local or international conferences


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.