Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000966695
Ethics application status
Approved
Date submitted
1/08/2023
Date registered
6/09/2023
Date last updated
6/09/2023
Date data sharing statement initially provided
6/09/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Delineating gastric emptying after major gastro-oesophageal surgery using real time MRI
Scientific title
Delineating gastric emptying after major gastro-oesophageal surgery using real time MRI
Secondary ID [1] 307321 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastric conduit dysmotility 330953 0
Gastric Conduit Emptying Failure 330954 0
Oesophagectomy 331073 0
Condition category
Condition code
Surgery 327757 327757 0 0
Other surgery
Oral and Gastrointestinal 327863 327863 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant (with a previous oesophagectomy) will present to the MRI department fasted for 8 hours. The MRI will take approximately 30 minutes.
Immediately prior to the MRI, the participant will consume a semi solid porridge meal, consisting of 34 grams of oats, sugar, honey, and milk powder.
An MRI will be performed by a specialised MRI radiographer, and the following sequences will be attained: T2 Volume acquisition, followed by T2 weighted true fast imaging with steady state free precession (TRUFI) free breathing sequence for 4 minutes. This block will be repeated 4 times. Then a final volume acquisition T2 Volume sequence will be completed.
A specialised radiologist or surgeon investigator will be present for the scan to ensure all sequences are adequately completed.
No IV contrast will be used. No further follow-up scans are required.

Intervention code [1] 326644 0
Diagnosis / Prognosis
Comparator / control treatment
Subjects with normal gastric anatomy will undergo an MRI with the identical procedures to the patients with a prior oesophagectomy, outlined above.
Control group
Active

Outcomes
Primary outcome [1] 335556 0
Gastric Peristalsis is the primary outcome. To measure this, we will assess each TRUFI (dynamic) phase of the MRI and measure the amplitude and velocity of each peristaltic wave. We will calculate the Gastric Motility Index as a surrogate measure of peristalsis by multiplying the amplitude (mm) by the velocity (mm/sec) of the largest peristaltic wave in each block.
Timepoint [1] 335556 0
Peristaltic waves will be quantified during each MRI TRUFI (dynamic) block at 5 minutes, 11 minutes, 17 minutes and 23 minutes.
Secondary outcome [1] 424939 0
Gastric Emptying is a secondary outcome. This will be assess by calculating the conduit volume at the beginning and end of the MRI scanning period, and measuring the % of emptying.
Timepoint [1] 424939 0
The first and last volume scans will be performed approximately 20 minutes apart.
Secondary outcome [2] 425245 0
Allens Reflux and Regurgitation score
Timepoint [2] 425245 0
At the time of the MRI, at least 2 years post oesophagectomy
Secondary outcome [3] 426317 0
Dakkak Dysphagia Scores
Timepoint [3] 426317 0
At the time of the MRI, at least 2 years post oesophagectomy
Secondary outcome [4] 426318 0
Sigstad dumping scores,
Timepoint [4] 426318 0
At the time of the MRI, at least 2 years post oesophagectomy
Secondary outcome [5] 426319 0
Rand SF-35 Quality of Life scores
Timepoint [5] 426319 0
At the time of the MRI, at least 2 years post oesophagectomy

Eligibility
Key inclusion criteria
Interventional Group:
> 2 years post oesophagectomy

Control Group:
Normal gastrointestinal Anatomy
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Interventional group:
Known gastrointestinal dysmotility
Medications that may affect gastric motility
Recurrence of Cancer
Prior gastrointestinal operations (other than oesopahgectomy) that may affect intestinal transit

Control group:
Known gastrointestinal dysmotility
Medications that may affect gastric motility
Prior gastrointestinal operations (other than oesopahgectomy) that may affect intestinal transit

Study design
Purpose of the study
Diagnosis
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
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/08/2021
Date of last participant enrolment
Anticipated
4/11/2023
Actual
Date of last data collection
Anticipated
4/12/2023
Actual
Sample size
Target
36
Accrual to date
34
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 40978 0
3004 - St Kilda Road Melbourne

Funding & Sponsors
Funding source category [1] 311614 0
University
Name [1] 311614 0
Monash University
Country [1] 311614 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
The Alfred
55 Commercial road
Melbourne, Vic
3004
Country
Australia
Secondary sponsor category [1] 313048 0
None
Name [1] 313048 0
Address [1] 313048 0
Country [1] 313048 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311056 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 311056 0
Ethics committee country [1] 311056 0
Australia
Date submitted for ethics approval [1] 311056 0
Approval date [1] 311056 0
12/11/2020
Ethics approval number [1] 311056 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119842 0
Dr Paul Burton
Address 119842 0
Department of General Surgery, The Alfred HospitalLevel 6, 99 Commercial Road, Prahran, Victoria, 3181
Country 119842 0
Australia
Phone 119842 0
+613 85730000
Fax 119842 0
Email 119842 0
[email protected]
Contact person for public queries
Name 119843 0
Julie Playfair
Address 119843 0
Centre for Obesity Research and Education, Monash UniversityLevel 6, The Alfred Centre, 99 Commercial Road, Prahran, Victoria, 3181
Country 119843 0
Australia
Phone 119843 0
+613 9903 0725
Fax 119843 0
Email 119843 0
[email protected]
Contact person for scientific queries
Name 119844 0
Kaleb Lourensz
Address 119844 0
Department of General Surgery, The Alfred HospitalLevel 6, 99 Commercial Road, Prahran, Victoria, 3181
Country 119844 0
Australia
Phone 119844 0
+613 9076 2000
Fax 119844 0
Email 119844 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not part of ethics approval


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.