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Trial registered on ANZCTR


Registration number
ACTRN12624000822583
Ethics application status
Approved
Date submitted
24/05/2024
Date registered
4/07/2024
Date last updated
4/07/2024
Date data sharing statement initially provided
4/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Stomach Electrical Activity Following Oesophageal Cancer Surgery
Scientific title
Measuring Gastric Conduit Electrophysiology at 12 months post Ivor-Lewis Oesophagectomy to Characterise Delayed Gastric Conduit Emptying after Oesophageal Cancer Surgery
Secondary ID [1] 312214 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delayed gastric conduit emptying 333892 0
Oesophageal cancer 333971 0
Condition category
Condition code
Oral and Gastrointestinal 330571 330571 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 330639 330639 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Gastric Alimetry is a non-invasive transcutaneous device which has been validated in assessing gastric motility in patients, using cutaneous sensors to monitor gastric electrophysiology and comparing to patient reported symptoms using patient feedback tools. The technology uses a high-resolution array of 64 electrodes applied to the anterior abdominal wall and epigastrium with the intention of measuring gastric electrical activity. It is comparable to an ECG test of the heart, however longer in duration to account for the lower frequency of the gastric electrical activity. Its non-invasive component provides an acceptable alternative to other measurement tools for gastric electrical activity, however the clinical utility in patients post-oesophagectomy is not yet explored.
Patients will only be assessed with Gastric Alimetry as part of their enrollment in the study.
Information that will be assessed from participants includes information from electronic medical records, study-specific questionnaires, as well as gastric motility activity. The patient questionnaire is anticipated to take 20 minutes to complete, and the gastric motility assessment is anticipated to take approximately 4 hours.
The administration of the gastric motility assessment will be undertaken by a trained medical doctor.
Adherence to the gastric motility assessment is binary and measured by whether the participant is able to complete the entire duration of the assessment as well as all study questionnaires.
Intervention code [1] 328711 0
Diagnosis / Prognosis
Comparator / control treatment
Participants with no clinical or radiological evidence of delayed gastric conduit emptying will undergo the same assessment as the intervention/exposure group, that being Gastric Alimetry motility assessment as well as symptom questionnaires.
Control group
Active

Outcomes
Primary outcome [1] 338325 0
Gastric motility activity - Electrical mapping composite outcome
- Principal gastric frequency
- BMI-adjusted average amplitude
Timepoint [1] 338325 0
Continuous Gastric Alimetry data collection will occur during a the four-hour assessment period.
Secondary outcome [1] 436846 0
Nil
Timepoint [1] 436846 0
Nil

Eligibility
Key inclusion criteria
- Patients least 12 months post oesophagectomy at Peter MacCallum Cancer Centre
- Adults aged 18 and over
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical testing will be performed according to the data type. To compare results between symptomatic patients and controls, we will employ relevant tests to the parameters / variables such as the two-sided Fisher’s exact test for the categorical variables and one-way analysis of variance (ANOVA) for continuous variables. Correlation testing will be used to correlate clinical symptoms vs electrophysiological outcomes in the patient groups.
To do this, the sub-type of electrical abnormalities will be determined, based on a previous article describes that describes the various amplitude subtype patterns – low rhythm stability/low amplitude, high stable amplitude, isolated frequency deviations – and their physiological meaning. A total symptom burden bar, constructed from patient-reported outcomes, will be compared against transient spectral abnormalities from the gastric amplitude curves. This comparison will be made through a subjective visual assessment whereby the timing, type and number of symptom ‘events’ are correlated against gastric electrical activity changes. Additionally, we will also determine the associations between all the study variables with Pearson’s correlation coefficient and will report statistically significant correlations after Benjamini-Hochberg correction (a=.05).
Slow wave parameters will also be compared to quality of life and symptom scores (PAGI-SYM, PAGI-QoL)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/07/2024
Actual
Date of last participant enrolment
Anticipated
30/07/2026
Actual
Date of last data collection
Anticipated
30/07/2026
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26572 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 42615 0
3052 - Melbourne University
Recruitment postcode(s) [2] 42616 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 316597 0
Self funded/Unfunded
Name [1] 316597 0
Unfunded
Country [1] 316597 0
Primary sponsor type
Individual
Name
A/Prof Cuong Duong
Address
Country
Australia
Secondary sponsor category [1] 318778 0
Hospital
Name [1] 318778 0
Clinical Research Development and Operations (CRDO) of Peter MacCallum Cancer Centre
Address [1] 318778 0
Country [1] 318778 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315375 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 315375 0
https://www.petermac.org/research/doing-research-us/ethics-governance
Ethics committee country [1] 315375 0
Australia
Date submitted for ethics approval [1] 315375 0
29/02/2024
Approval date [1] 315375 0
23/04/2024
Ethics approval number [1] 315375 0
HREC/104754/PMCC

Summary
Brief summary
This study investigates the characteristic electrical activity of the stomach conduit in patients with delayed gastric conduit emptying (DGCE), a clinical condition characterised by persistent nausea and difficulty swallowing after oesophageal cancer surgery.

Who is it for?
You may be eligible for this study if you are an adult male or female who has previous has had oesophageal cancer surgery at Peter MacCallum Cancer Centre atleast 12 months ago.

Study details
All participants will undergo a series of patient questionnaires regarding their symptoms, followed by a 4-hour gastric motility assessment using the device known as 'Gastric Alimetry', which works similarly to an ECG for the stomach. This will facilitate the identification of electrical activity characteristics for DGCE and validate the role of Alimetry in diagnosing DGCE.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134506 0
A/Prof Cuong Duong
Address 134506 0
Peter MacCallum Cancer Centre, 305 Grattan St, Melbourne VIC 3052
Country 134506 0
Australia
Phone 134506 0
+61 3 8559 7665
Fax 134506 0
Email 134506 0
[email protected]
Contact person for public queries
Name 134507 0
Jonathan Sivakumar
Address 134507 0
Peter MacCallum Cancer Centre, 305 Grattan St, Melbourne VIC 3052
Country 134507 0
Australia
Phone 134507 0
+61 3 8559 5000
Fax 134507 0
Email 134507 0
[email protected]
Contact person for scientific queries
Name 134508 0
Jonathan Sivakumar
Address 134508 0
Peter MacCallum Cancer Centre, 305 Grattan St, Melbourne VIC 3052
Country 134508 0
Australia
Phone 134508 0
+61 3 8559 5000
Fax 134508 0
Email 134508 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
Individual participant data will not be available as this is a de-identified clinical study and the principal of confidentially will be upheld to protect patient privacy.


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.