Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001592831
Ethics application status
Approved
Date submitted
24/08/2021
Date registered
22/11/2021
Date last updated
22/11/2021
Date data sharing statement initially provided
22/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cohort study of meso-Rex shunts in Queensland children with extra hepatic portal vein obstruction.
Scientific title
Cohort study of meso-Rex shunts in Queensland children with extra hepatic portal vein obstruction.
Secondary ID [1] 305130 0
None
Universal Trial Number (UTN)
U1111-1269-0100
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Extrahepatic portal venous obstruction 323367 0
Condition category
Condition code
Oral and Gastrointestinal 320937 320937 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 320938 320938 0 0
Surgical techniques

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Meso-Rex shunt surgery is performed in Queensland Children for extra hepatic portal venous obstruction as a curative procedure. This operation takes anywhere from 4-6 hours to perform, and involves creating a bypass graft from the superior mesenteric vein, to the left portal vein - to bypass the obstructed portal vein which would normally lie between these structures. The shunt is invariably native vein, and is most commonly performed using harvested internal jugular vein from the right side of the neck. Other abdominal vessels may be used to bypass the mesenteric circulation to the left portal vein - including the inferior mesenteric vein, or varicosed vessels. Such an approach has the potential advantages of avoiding a neck dissection, and it also avoids one anastomosis in the abdomen. Not all patients have suitable vessels intra-abdominally, hence the common use of the right internal jugular vein.
These operations are performed by adult hepatobiliary and transplant surgeons, assisted by hepatobiliary paediatric surgeons at Queensland Children's Hospital.
Follow-up for these patients begins during their admission; with daily bloods and an ultrasound scan at day 1 and 5 post operatively. Following discharge, there is ongoing follow up through the liver clinic at QCH at 6, 12, 26 and 52 weeks, and ongoing thereafter. Follow up includes blood tests of liver function, platelet count and haemoglobin, and coagulation parameters. It also includes ultrasound scanning to ensure shunt latency. It also includes surveillance endoscopy for oesophageal varices.
Surgery on these patients is performed irrespective of their involvement in this cohort study or not. Patient and family consent will be sought for inclusion of de-identified data within the cohort study.
Demographics and medical records for participants who received Meso-Rex shunt surgery from the first patient (2009) until the most recent patient will be accessed as part of the study.
Intervention code [1] 321540 0
Diagnosis / Prognosis
Comparator / control treatment
No control group - cohort study of outcomes
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328720 0
Shunt patency - assessed using Doppler sonography.
Timepoint [1] 328720 0
Day 1, Day 5, and at weeks 6, 12, 26, 52 and ongoing six monthly reviews until aged 18 (transition to adult services) or to end of 2021 (close date for data capture).
Secondary outcome [1] 400121 0
Oesophageal variceal bleeding with surveillance endoscopy and classified in accordance with the Italian Liver Cirrhosis Project (ILCP) Classification of Esophageal Varices. This is a retrospective study, so clinical records will be interrogated to determine frequency of endoscopy.
Timepoint [1] 400121 0
12 months post surgery, or sooner if symptoms (haematemesis) intervenes.

Eligibility
Key inclusion criteria
Queensland Children who have had Rex shunt surgery performed at Queensland Children's Hospital
Minimum age
No limit
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Other portal bypass (non-Rex) procedures. Abandoned Rex shunt. Adult patients

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Numbers expected to be low (approx 20), so descriptive statistics used predominantly. Non-parametric tests used where appropriate. Two-tailed tests, p<0.05 considered statistically significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/11/2021
Date of last participant enrolment
Anticipated
31/12/2021
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
20
Accrual to date
18
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 20338 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 35095 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 309522 0
Hospital
Name [1] 309522 0
Queensland Children's Hospital
Country [1] 309522 0
Australia
Primary sponsor type
Hospital
Name
Queensland Children's Hospital Department of Paediatric Surgery
Address
501 Stanley Street
South Brisbane
Qld 4101
Country
Australia
Secondary sponsor category [1] 310503 0
None
Name [1] 310503 0
Address [1] 310503 0
Country [1] 310503 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309303 0
Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 309303 0
Ethics committee country [1] 309303 0
Australia
Date submitted for ethics approval [1] 309303 0
01/10/2021
Approval date [1] 309303 0
12/10/2021
Ethics approval number [1] 309303 0
QA waiver approved by letter. No approval ID attached

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

Contacts
Principal investigator
Name 113694 0
A/Prof Craig McBride
Address 113694 0
Queensland Children's Hospital
501 Stanley Street
South Brisbane
Qld 4101
Country 113694 0
Australia
Phone 113694 0
+61 7 3068 5308
Fax 113694 0
Email 113694 0
[email protected]
Contact person for public queries
Name 113695 0
Craig McBride
Address 113695 0
Queensland Children's Hospital
501 Stanley Street
South Brisbane
Qld 4101
Country 113695 0
Australia
Phone 113695 0
+61 7 3068 5308
Fax 113695 0
Email 113695 0
[email protected]
Contact person for scientific queries
Name 113696 0
Craig McBride
Address 113696 0
Queensland Children's Hospital
501 Stanley Street
South Brisbane
Qld 4101
Country 113696 0
Australia
Phone 113696 0
+61 7 3068 5308
Fax 113696 0
Email 113696 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
The aggregated data file will be made available on reasonable request, and following review by the original ethics committee. Since numbers are small, it is possible individuals may be re-identified by a third party from this data set. Thus aggregated data only will be provided.


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.