Prophylactic Use of Antibiotics in Endoscopic Injection of Tissue Adhesive in Gastric Varices

Efficacy and Safety of Prophylactic Use of Antibiotics in Endoscopic Injection of Tissue Adhesive in Gastric Varices: A Multicenter Randomized Controlled Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03045783

Acronym

PUoA-EIoTA

Enrollment

912

Registered

2017-02-07

Start date

2016-12-31

Completion date

2019-07-31

Last updated

2017-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Gastric Varices

Keywords

gastric varices, endoscopic injection of tissue adhesive

Brief summary

The purpose of the study is to evaluate the efficacy and safety of prophylactic use of antibiotics in endoscopic injection of tissue adhesive in gastric varices.

Detailed description

Gastroesophageal variceal bleeding is the most common and life-threatening condition in patients with portal hypertension, which are susceptibility to bacterial infection. However, the prophylaxis use of antibiotics remained uncertain and lack of high level evidences.This study is a randomized controlled trial. The purpose of the study is to evaluate the efficacy and safety of prophylactic use of antibiotics in endoscopic injection of tissue adhesive in gastric varices.

Interventions

DRUGCefotiam

Prophylactic use of antibiotics group：Prophylactic use of antibiotics during endoscopic treatment, cefotiam 2.0g intravenous

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* 18 y.o. ≤age≤75 y.o.; * Diagnosis of esophageal gastric varices by gastroscopy; * Cirrhotic gastroesophageal variceal bleeding underwent endoscopic injection of tissue adhesive;

Exclusion criteria

* age \<18 y.o. or age \> 75 y.o.; * Never had the variceal bleeding episode before; * Do not have endoscopic injection of tissue adhesive; * The cefotiam contraindications: such as allergies, pregnancy etc; * combined with other malignant tumor (not exclude patients with hepatocellular carcinoma who don't not need treatment at the moment); * Known infection before endoscopic treatment (Fever, microbial cultures positive, et al.); * Massive ascites or combined with other high risk factor that require prophylaxis use of antibiotics; * Acute variceal bleeding within 5 days; * Refuse to participate

Design outcomes

Primary

Measure	Time frame	Description
The incidence of infection after endoscopic treatment	1 week	Patients will receive body temperature, blood routine, inflammatory markers examination before and after endoscopic treatment

Secondary

Measure	Time frame	Description
Rebleeding rate	2 months	Patients will be followed up and receive an endoscopic examination after patients have been followed up for 2 months.
Mortality rate	2 months	The investigators observe the mortality events during 2 months
All clinical events	2 months	All clinical events were defined as occurrence rebreeding, ascitic fluid infection, portal vein thrombosis, or death.
Serum endotoxin	before and the first day after endoscopic treatment	—
inflammatory factors including IL-6, IL-8, TNF-a, IL-1beta，IL-2R, IL-10	before and the first day after endoscopic treatment	—

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026