N-butyl-2-cyanoacrylate, Iso-amyl-2-cyanoacrylate and Hypertonic Glucose With 72% Chromated Glycerin in Gastric Varices
Condition: Gastric Varices
MeSH terms: Esophageal and Gastric Varices; Varicose Veins
Study type: Interventional

Summary: 
      AIM: To compare between n-butyl-2-cyanoacrylate, iso-amyl-2-cyanoacrylate and mixture of 72%
      chromated glycerin with hypertonic glucose solution in management of gastric varices.

      METHODS: Ninety patients with gastric varices presented to Endoscopy Unit of Ain Shams
      University Hospital were included. They were randomly allocated into three groups; each group
      included 30 patients treated with intravariceal sclerosant injections in biweekly sessions
      till complete obturation of gastric varices; Group I (n-butyl-2-cyanoacrylate; Histoacryl®),
      Group II (iso-amyl-2-cyanoacrylate; Amcrylate®) and Group III (mixture of 72% chromated
      glycerin; Scleremo® with glucose solution 25%). All the procedures were done electively
      without active bleeding. Recruited patients were followed up for 3 months.
    

Detailed description: 
      • Study Design & Sampling: This prospective randomized study is conducted on ninety patients
      with gastric varices presented to Endoscopy Unit of Ain Shams University Hospital. Patients
      with non-variceal causes for upper GIT bleeding and those with severe co-morbidity are
      excluded.

      Patients are randomly allocated into three groups; each group includes 30 patients who will
      be treated with sclerosant injections in biweekly sessions till complete obturation of
      gastric varices, with follow up for 3 months:

        -  Group I (Histoacryl® Group),

        -  Group II (Amcrylate® Group) and

        -  Group III (Scleremo® with Glucose 25% Group). The three groups are matching as regards
           age, gender, cause of liver cirrhosis (viral hepatitis B or C), Child score and
           endoscopic findings (including number, grade of EV and size of GV).

        -  Tools of the study:

      All included patients will be subjected to:

        1. Complete clinical evaluation.

        2. Laboratory investigations: CBC, liver profile, viral markers (HBs Ag, HB core Ab, HCV
           Ab) by ELISA technique.

        3. Child classification according to the modified Child Pugh's criteria [13].

        4. Abdominal ultrasonography: liver and spleen size, portal vein diameter and ascites.

        5. Upper gastrointestinal endoscopy: using Pentax video endoscope EG 3440. Esophageal
           varices are classified according to their size at the gastroesophageal junction into 4
           grades according to Westaby et al. [14].

           Gastric varices are classified into: gastro-esophageal varices (GEV) and isolated
           gastric varices (IGV) according to Sarin et al. [15].

        6. Therapeutic interventions:

      The intravariceal technique of injection is done according to Soehendra et al. [16].

      Histoacryl® is diluted as 0.5 ml histoacryl: 0.8 ml lipidol as a contrast agent to dilute the
      adhesive material to fill the whole varix and to prevent rapid hardening and obstruction of
      the needle. The mixture is injected slowly to minimize the risk of embolization followed by
      injection of 2 ml of distilled water. The first ml of water is injected to push the material
      into the varix and the second ml is injected during withdrawal of the needle to prevent its
      obstruction [8].

      Amcrylate® is injected slowly followed by injection of 2 ml distilled water without mixing
      with any other substances [17].

      Scleremo® is mixed with glucose 25% in a ratio of 1:1. The mixture is injected very slowly
      and with the waiting for moments inside the variceal lumen after injection to give enough
      time for the sclerosing material to be in contact with the vessel wall that helps
      haemostasis. There is no need for distilled water injection [11].

      Informed consent was obtained from all included patients and the study protocol was approved
      from the ethical guidelines committee.

      All the procedures are done electively without active bleeding. The primary end point of this
      study is the obturation of gastric varices. The secondary endpoint is the occurrence of
      bleeding whether from the puncture site during or immediately after injection or delayed
      (in-hospital or after discharge) and mortality.
    

Intervention name(s): injection sclerotherapy for gastric varices
Intervention type(s): Procedure
Intervention description(s): The intravariceal technique of injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment