ANZCTR - Registration

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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]

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

Condition category

Condition code

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Surgery

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]

Diagnosis / Prognosis

Comparator / control treatment

No control group - cohort study of outcomes

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Shunt patency - assessed using Doppler sonography.

Timepoint [1]

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]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Queensland Children's Hospital - South Brisbane

Recruitment postcode(s) [1]

4101 - South Brisbane

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Queensland Children's Hospital

Address [1]

501 Stanley Street
South Brisbane
Qld 4101

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee

Ethics committee address [1]

Centre for Children’s Health Research, 
Queensland Children’s Hospital Precinct, 
Level 7, 62 Graham Street, 
South Brisbane 
QLD 4101

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/10/2021

Approval date [1]

12/10/2021

Ethics approval number [1]

QA waiver approved by letter. No approval ID attached

Summary

Brief summary

Extrahepatic portal venous obstruction (EHPVO) is a condition where venous flow into the liver becomes obstructed. As a result, blood bypasses the liver via a series of other channels that open up. The liver consequently receives less blood flow. This can lead to abnormalities of liver function, and varices that can bleed (most commonly in the lower oesophagus). The Rex shunt is a selective shunt that is designed to relieve the complications of EHPVO by connecting mesenteric venous flow to the left portal vein, using one of a number of described conduits.
Queensland Children's Hospital is the only facility in Queensland performing this operation. To date outcomes have not been collated or reported for any facility in Australia. This will be the first study to do so. As a part of this study, and to determine outcomes to report, a systematic review of the literature is being performed. This systematic literature review will identify reported outcomes in the extant literature. The most common, or important, of these reported outcomes will be used for this study cohort. 
Data related to this cohort have already been gathered during the course of clinical care. Where possible, outcomes will be reported. If an outcome is determined important, but has not been collected to date, this will inform future data gathering for these patients.

Trial website

Nil

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Craig McBride

Address

Queensland Children's Hospital
501 Stanley Street
South Brisbane
Qld 4101

Country

Australia

Phone

+61 7 3068 5308

Fax

Craig.McBride@health.qld.gov.au

Contact person for public queries

Name

Craig McBride

Address

Queensland Children's Hospital
501 Stanley Street
South Brisbane
Qld 4101

Country

Australia

Phone

+61 7 3068 5308

Fax

Craig.McBride@health.qld.gov.au

Contact person for scientific queries

Name

Craig McBride

Address

Queensland Children's Hospital
501 Stanley Street
South Brisbane
Qld 4101

Country

Australia

Phone

+61 7 3068 5308

Fax

Craig.McBride@health.qld.gov.au

Data sharing statement

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

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.

Trial Review

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