How are you taking part in this consultation?

You will not be able to change how you comment later.

You must be signed in to answer questions

    The content on this page is not current guidance and is only for the purposes of the consultation process.

    Summary of key evidence on BATO for gastric varices

    Study 7 Tian X (2011)

    Study details

    Study type

    Retrospective, single centre, case series

    Country

    China

    Recruitment period

    2003 to 2009

    Study population and number

    n=73 (71 followed up)

    People with acute or recent gastric varices bleeding who had percutaneous transhepatic obliteration.

    Age and sex

    Mean 50.3 years; 62% male

    Patient selection criteria

    Inclusion criteria: acute gastric variceal bleeding or a history of gastric variceal bleeding within 6 months of hospital admission.

    Exclusion criteria: serum bilirubin level of more than 100 mg/L, serum creatinine value of greater than 2 mg/dL, platelet count of less than 20,000/mm3, complete obstruction of the portal vein because of thrombosis, hepatic encephalopathy greater than stage II, hepatorenal syndrome, and cardiorespiratory failure.

    Technique

    Percutaneous transhepatic obliteration under local anaesthesia. Percutaneous transhepatic puncture of the intrahepatic branch of the portal vein was performed. Splenoportography was done to evaluate the gastric varices, the feeding veins, and the draining veins.

    In people without large gastrorenal shunts, cyanoacrylate was injected directly into the gastric varices. For people with large gastrorenal shunts, a balloon catheter was inserted into the left renal vein via the right femoral vein to reduce the gastrorenal shunt blood flow. Afterward, cyanoacrylate was injected into the gastric varices.

    Follow up

    Mean 24.2 months (SD 12.4 months)

    Conflict of interest/source of funding

    Conflict of interest: Not reported.

    Source of funding: Not reported.

    Analysis

    Follow up issues: The procedure was unsuccessful in 2 people – both were excluded from the analysis.

    Study design issues: This retrospective case series reported the outcomes of percutaneous transhepatic obliteration for gastric varices. People were identified retrospectively from medical records. People in which the procedure failed were excluded from the analysis. Outcomes included technique outcomes (extent of obliteration), rebleeding rates, survival, and complications.

    The Kaplan-Meier method was used to examine the rebleeding rate and survival rate value. p<0.05 was considered statistically significant.

    Study population issues: The aetiology was hepatitis B in 40 people (56%), hepatitis C in 13 (18%), alcohol in 13 (18%), and unspecified 'others' in 5 (7%). There were 24 people (34%) classified as Child-Pugh grade A, 31 (44%) as grade B, and 16 (23%) as grade C. The location of gastric varices was GOV2 in 41 people (58%) and IGV1 in 30 people (42%). The form of gastric varices was F1 in 18 people (25%), F2 in 26 (37%), and F3 in 32 (45%). A total of 15 people (21%) had hepatocellular carcinoma.

    Key efficacy findings

    Technique outcomes

    Number of people analysed: 71

    • Complete obliteration, with all the gastric varices and their feeding veins obliterated, was achieved in 67 people (94.4%).

    • Partial obliteration, with only the feeding veins obliterated, was achieved in the remaining 4 people (5.6%).

    Rebleeding

    Number of people analysed: 71

    • During the follow up period, rebleeding occurred in 7 people (9.9%). Rebleeding was due to:

      • Gastric varices, n=4 (5.6%)

      • Oesophageal varices, n=2 (2.8%)

      • Portal hypertensive gastropathy, n=1 (1.4%)

    • The cumulative probability of remaining free of rebleeding at 1 year was 98.4%, at 3 years was 77.7%, and at 5 years was 77.7%.

    Survival

    Number of people analysed: 71

    • During the follow-up, 13 people (18.3%) died:

      • Hepatocellular carcinoma, n=7

      • Progression of hepatic failure, n=5

      • Uncontrolled rebleeding, n=1

    • The cumulative survival rate at 1 year was 96.9%, at 3 years was 68.9%, and at 5 years was 53.7%.

    Key safety findings

    Complications

    Number of people analysed: 71

    The following complications were reported:

    • Bacteraemia, n=5 (7%)

    • Transient fever greater than 38°C, n=32 (45%)

    • Abdominal pain, n=25 (35%)

    • Ulcer, n=3 (4%)

    • Spontaneous bacterial peritonitis, n=6 (8%)

    • Ascites, n=20 (28%)

    • Portal vein thrombosis, n=2 (3%)

    • Aggravated oesophageal varices, n=6 (8%)