Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001089426
Ethics application status
Approved
Date submitted
10/08/2016
Date registered
12/08/2016
Date last updated
17/06/2019
Date data sharing statement initially provided
17/06/2019
Date results information initially provided
17/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Using nuclear medicine scans to measure gastric and oesophageal function after major upper gastro-intestinal surgery
Scientific title
Using nuclear scintigraphy to measure gastric emptying and oesophageal transit following major upper gastro-intestinal surgery
Secondary ID [1] 289909 0
Nil known
Universal Trial Number (UTN)
U1111-1186-2254
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oesophageal resection 299874 0
Gastric resection 299875 0
Condition category
Condition code
Oral and Gastrointestinal 299780 299780 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients who have undergone major upper gastrointestinal surgery (oesophageal resection, gastric resection, sleeve gastrectomy) will be recruited to undergo nuclear scintigraphy (nuclear medicine scans) to examine their oesophageal transit and gastric emptying. These scans will be repeated over 2 years to observe any changes in function (e.g. return to normal function).

Scans will be done at 4 weeks after surgery, 6 months, 12 months and 24 months. Each nuclear medicine scan will take about two hours. Patients will then be asked to swallow a mouthful of porridge twice while sitting in front of the camera. Following which they will be given 3/4 of a cup of porridge to which has been mixed with some radioactive marker that can be detected by the scanners. They will then lie down for the remainder of the study with images being taken for about 90 minutes.

Scans results will be correlated to symptoms, assessed by validated questionnaires done at the same time as the scans.
Intervention code [1] 295591 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299247 0
Examination of oesophageal and gastric transit/emptying (oesophagus and stomach are connected and we will be measuring transit or "emptying" through them) by nuclear scintigraphy
Timepoint [1] 299247 0
0, 6, 12, 24 months post surgery
Secondary outcome [1] 326629 0
Correlation of oesophageal and gastric transit/emptying (assessed by nuclear scintigraphy) to symptoms (assessed by questionnaire - SF36, reflux and dysphagia scores (validated), and non-validated gastrointestinal symptoms questionnaire designed for the study)
Timepoint [1] 326629 0
0, 6, 12, 24 months after surgery

Eligibility
Key inclusion criteria
Patients consist of two groups:
Group 1: Oesophageal reconstruction group
Group 2: Sleeve gastrectomy (bariatric surgical) group

These patients are recruited prospectively, to allow inclusion of 6 week post-operative scan.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy or breastfeeding

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Standardised statistical analyses of paired measurements and comparisons between groups will be made. A p value of 0.05 will be considered significant.
Our power calculations have determined that when comparing emptying times at different time points with 16 patients per group (hence, total 20 patients to account for an expected 20% drop out), this study will have an 80% power to detect a difference in continuously normally distributed variables equivalent to 0.8 standard deviations, with a two sided p-value of 0.05.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
5/09/2016
Actual
3/10/2016
Date of last participant enrolment
Anticipated
4/03/2018
Actual
28/05/2018
Date of last data collection
Anticipated
4/05/2020
Actual
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6468 0
The Alfred - Prahran
Recruitment postcode(s) [1] 14022 0
3181 - Prahran
Recruitment postcode(s) [2] 14023 0
3004 - Prahran

Funding & Sponsors
Funding source category [1] 294278 0
Hospital
Name [1] 294278 0
Department of Surgery, The Alfred Hospital
Country [1] 294278 0
Australia
Primary sponsor type
Hospital
Name
The Alfred Hospital
Address
99 Commercial Road,
Prahran, Victoria, 3181
Country
Australia
Secondary sponsor category [1] 293113 0
University
Name [1] 293113 0
Monash University
Address [1] 293113 0
Centre for Obesity Research and Education,
Level 6, The Alfred Centre,
99 Commercial Road,
Prahran, Victoria, 3181
Country [1] 293113 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295710 0
The Alfred HREC
Ethics committee address [1] 295710 0
99 Commercial Road,
Prahran, Victoria, 3181
Ethics committee country [1] 295710 0
Australia
Date submitted for ethics approval [1] 295710 0
03/08/2016
Approval date [1] 295710 0
01/09/2016
Ethics approval number [1] 295710 0

Summary
Brief summary
BACKGROUND
Patients who undergo major upper gastro-intestinal surgery, such as oesophageal reconstruction or bariatric surgery, have substantially altered stomach and oesophageal anatomy, and therefore both oesophageal transit and gastric emptying are much different.
Altered sensations and symptoms, such as reflux, regurgitation and nausea, are sometimes reported by patients. These symptoms are known to be a major determinant of the overall outcome of the procedure and significantly affect patients’ quality of life.
Currently, there are few accurate tests able to assess the function of the stomach and oesophagus after major upper gastro-intestinal surgery.
Nuclear scintigraphy is a functional test that has considerable utility in the assessment of gastric emptying and oesophageal transit. Observed function can be correlated with outcomes and symptoms. Scintigraphy is well established in assessing symptoms of reflux, swallowing and suspected alterations in gastric emptying.

AIMS
In this study we aim to establish the normal gastro-intestinal transit function in patients following major upper gastro-intestinal surgery and also correlate the physiology of transit, and emptying with reported levels of reflux, regurgitation and satiety.
The aim is to:
1) Establish normative values and determine the expected pattern of oesophageal transit, gastric emptying and small bowel transit following upper gastrointestinal surgery
2) Determine if the patterns of oesophageal transit and gastric emptying and change over time following major upper gastro-intestinal surgery

HYPOTHESIS
A differing pattern of oesophageal transit, gastric and intestinal transit is observed following upper gastro-intestinal surgery. This patterns changes substantially over the first year following surgery and then stabilises.

BRIEF METHODS
Patients will be recruited prior to their major upper gastrointestinal surgery (oesophageal or gastric resection, or sleeve gastrectomy). They will undergo 4 nuclear scintigraphy scans after their operations to establish the new function of the reconstructed upper gastrointestinal tract, and correlated these with symptoms, as assessed by validated questionnaires.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68182 0
Mr Paul Burton
Address 68182 0
Department of General Surgery, The Alfred Hospital
Level 6, 99 Commercial Road,
Prahran, Victoria, 3181
Country 68182 0
Australia
Phone 68182 0
+613 9076 2000
Fax 68182 0
Email 68182 0
[email protected]
Contact person for public queries
Name 68183 0
Ms Cheryl Laurie
Address 68183 0
Centre for Obesity Research and Education, Monash University
Level 6, The Alfred Centre,
99 Commercial Road,
Prahran, Victoria, 3181
Country 68183 0
Australia
Phone 68183 0
+613 9903 0725
Fax 68183 0
Email 68183 0
[email protected]
Contact person for scientific queries
Name 68184 0
Mr Paul Beech
Address 68184 0
Department of Nuclear Medicine, The Alfred Hospital
Level 1, Phillip Block,
99 Commercial Road,
Prahran, Victoria, 3181
Country 68184 0
Australia
Phone 68184 0
+613 9076 2000
Fax 68184 0
Email 68184 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


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.