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Clinical Trials/NCT02330731
NCT02330731CompletedNot Applicable

N-butyl-2-cyanoacrylate, Iso-amyl-2-cyanoacrylate and Hypertonic Glucose With 72% Chromated Glycerin in Gastric Varices

Ain Shams University0 sites90 target enrollmentStarted: January 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
90
Primary Endpoint
obturation of gastric varices

Study Overview

Brief 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].

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
25 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients with gastric varices presented to Endoscopy Unit of Ain Shams University Hospital

Exclusion Criteria

  • Patients with non-variceal causes for upper GIT bleeding and those with severe co-morbidity

Outcomes

Primary Outcomes

obturation of gastric varices

Time Frame: 3 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sara Abdelhakam

Dr

Ain Shams University

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