ANZCTR - Registration

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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

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]

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

Gastric resection

Condition category

Condition code

Oral and Gastrointestinal

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]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

0, 6, 12, 24 months post surgery

Secondary outcome [1]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Alfred - Prahran

Recruitment postcode(s) [1]

3181 - Prahran

Recruitment postcode(s) [2]

3004 - Prahran

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Department of Surgery, The Alfred Hospital

Address [1]

99 Commercial Road,
Prahran, Victoria, 3181

Country [1]

Australia

Primary sponsor type

Hospital

Name

The Alfred Hospital

Address

99 Commercial Road,
Prahran, Victoria, 3181

Country

Australia

Secondary sponsor category [1]

University

Name [1]

Monash University

Address [1]

Centre for Obesity Research and Education,
Level 6, The Alfred Centre,
99 Commercial Road,
Prahran, Victoria, 3181

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Alfred HREC

Ethics committee address [1]

99 Commercial Road, 
Prahran, Victoria, 3181

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

03/08/2016

Approval date [1]

01/09/2016

Ethics approval number [1]

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

Mr Paul Burton

Address

Department of General Surgery, The Alfred Hospital
Level 6, 99 Commercial Road,
Prahran, Victoria, 3181

Country

Australia

Phone

+613 9076 2000

Fax

paul.burton@monash.edu

Contact person for public queries

Name

Cheryl Laurie

Address

Centre for Obesity Research and Education, Monash University
Level 6, The Alfred Centre,
99 Commercial Road,
Prahran, Victoria, 3181

Country

Australia

Phone

+613 9903 0725

Fax

cheryl.laurie@monash.edu

Contact person for scientific queries

Name

Paul Beech

Address

Department of Nuclear Medicine, The Alfred Hospital
Level 1, Phillip Block,
99 Commercial Road,
Prahran, Victoria, 3181

Country

Australia

Phone

+613 9076 2000

Fax

p.beech@alfred.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

Trial Review

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