RecruitingACTRN12621001592831

Cohort study of meso-Rex shunts in Queensland children with extra hepatic portal vein obstruction.

Sponsor

Queensland Children's Hospital Department of Paediatric Surgery

Enrollment

20 participants

Start Date

Nov 1, 2021

Study Type

Observational

Conditions

Extrahepatic portal venous obstruction

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.

Eligibility

Sex: Both males and femalesMax Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Extrahepatic portal venous obstruction (EHPVO) is a condition in children where the vein that carries blood into the liver becomes blocked. This causes blood to reroute through other vessels, which can lead to dangerous bleeding (especially in the oesophagus) and problems with liver function. A surgical procedure called the Rex shunt corrects this by re-establishing proper blood flow to the liver — and Queensland Children's Hospital is the only facility in Queensland performing this operation. This is a retrospective cohort study, meaning researchers are reviewing the medical records of children who have already had this surgery to understand how they did over time. They are not recruiting new patients for a new treatment — instead, they are systematically collecting and analysing outcomes data that was gathered during routine clinical care. The study is open to Queensland children who have undergone Rex shunt surgery at Queensland Children's Hospital. This research is important because no Australian hospital has previously published its outcomes data for this procedure, and doing so will help improve care for future patients with this condition.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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.

Locations(1)

Queensland Children's Hospital - South Brisbane

QLD, Australia

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ACTRN12621001592831