Background
Portal hypertension is defined as an increase in the blood pressure within a system of veins (a type of blood vessel) called the portal venous system, which drains blood from the gastrointestinal tract (gut) and spleen into the liver. Portal hypertension commonly accompanies advanced liver disease and often gives rise to life-threatening complications, including haemorrhage (bleeding) from oesophageal (gullet) and gastrointestinal varices (enlarged or swollen veins).
In adults, numerous randomised clinical trials (studies where people are randomly allocated to one of two or more treatment groups) have demonstrated benefits of medicines called non-selective beta-blockers and endoscopic variceal ligation (where an enlarged vein is tied off or ligated by a rubber band) on the risk of first variceal haemorrhage. These treatments are used as primary prophylaxis (preventing or increasing resistance to disease that has not occurred) in adults, but it is unknown whether they are of benefit or cause harm when used in children and adolescents. Sclerotherapy (the endoscopic injection of tissue irritants that cause obliteration of blood vessels) is the only endoscopic prophylactic option currently available in infants weighing less than 10 kg of body weight (because of the size).
Aims
We aimed to conduct a systematic review of randomised clinical trials to assess the benefits and harms of band ligation versus sclerotherapy for prevention of oesophageal variceal bleeding in children with chronic liver disease or portal vein thrombosis (blockage or narrowing of the portal vein (the blood vessel that brings blood to the liver from the intestines) by a blood clot). We searched for trials to 27 April 2020.
Key results
We found no randomised clinical trials for inclusion in this systematic review. Accordingly, we lack results from randomised clinical trials to conclude if band ligation compared with sclerotherapy may be beneficial or not in children and adolescents with oesophageal varices. There is a need for well-designed trials that should include important clinical outcomes such as death, quality of life, failure to control of variceal bleeding, and side effects.
Randomised clinical trials assessing the benefits or harms of band ligation versus sclerotherapy for primary prophylaxis of oesophageal variceal bleeding in children with chronic liver disease or portal vein thrombosis are lacking. Therefore, trials with adequate power and proper design, assessing the benefits and harms of band ligation versus sclerotherapy on patient-relevant clinical outcomes such as mortality, quality of life, failure to control variceal bleeding, and adverse events are needed. Unless such trials are conducted and the results become published, we cannot make any conclusions regarding the benefits or harms of these two interventions.
Portal hypertension commonly accompanies advanced liver disease and often gives rise to life-threatening complications, including haemorrhage from oesophageal and gastrointestinal varices. Variceal haemorrhage commonly occurs in children with chronic liver disease or portal vein obstruction. Prevention is therefore important. In adults, numerous randomised clinical trials have demonstrated benefits of non-selective beta-blockers and endoscopic variceal ligation as primary prevention in decreasing the risk of variceal haemorrhage. In children, band ligation, beta-blockers, and sclerotherapy have been proposed as alternatives for primary prophylaxis of oesophageal variceal bleeding. However, primary prophylaxis is not the current standard of care in children because it is unknown whether those treatments are of benefit or cause harm when used for primary prophylaxis of oesophageal variceal bleeding in children and adolescents.
To determine the benefits and harms of band ligation versus sclerotherapy for primary prophylaxis of oesophageal variceal bleeding in children and adolescents with chronic liver disease or portal vein thrombosis.
We searched the Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, PubMed, Embase, LILACS, and Science Citation Index Expanded (27 April 2020). We scrutinised the reference lists of retrieved publications, and performed a manual search from the main paediatric gastroenterology and hepatology conferences (NASPGHAN and ESPGHAN) abstract books from 2008 to 2019. We searched ClinicalTrials.gov, FDA, EMA, and WHO for ongoing clinical trials. There were no language or document type restrictions.
We planned to include randomised clinical trials irrespective of blinding, language, or publication status for assessment of benefits and harms. If the search for randomised clinical trials retrieved quasi-randomised and observational studies, then we read them through to extract information on harms.
We planned to summarise data from randomised clinical trials by standard Cochrane methodologies. We planned to assess risk of bias and use GRADE to assess the certainty of evidence per outcome. Our primary outcomes were all-cause mortality, serious adverse events and liver-related morbidity, and quality of life. Our secondary outcomes were oesophageal variceal bleeding and adverse events not considered serious. We planned to analyse data with intention-to-treat. We planned to use Review Manager 5 to analyse the data.
We found no randomised clinical trials assessing band ligation versus sclerotherapy for primary prophylaxis of oesophageal variceal bleeding in children with chronic liver disease or portal vein thrombosis.