Efficiency and Safety of Prophylactic Use of Antibiotics in Endoscopic Injection of Tissue Adhesive in Gastric Varices

NCT02693951 | Unknown

• 1 other identifier: CSY-LCF-2016
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastric Varices; Cirrhosis

Keywords

gastric varices; endoscopic injection of tissue adhesive

Outcome Measures

Primary Outcomes (1)

• The incidence of infection after endoscopic treatment

  Patients will receive body temperature, blood routine, inflammatory markers examination before and after endoscopic treatment.

  1 week

Secondary Outcomes (2)

• Rebleeding rate

  2 months

• Mortality rate

  2 months

Study Arms (2)

the prophylactic use of antibiotics group

EXPERIMENTAL

Half an hour before endoscopic treatment, cefotiam 2.0g intravenous

Drug: Cefotiam

Control

NO INTERVENTION

Routine endoscopic examination and treatment. Antibiotics are not used before endoscopic treatment

Interventions

Cefotiam DRUG

Prophylactic use of antibiotics group: Half an hour before endoscopic treatment, cefotiam 2.0g intravenous

Also known as: HaiTiShu

the prophylactic use of antibiotics group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Capable of understanding the purpose and risks of the study and informed consent to participate in the study;
• age between 18-75 years old;
• Diagnosis of esophageal gastric varices by gastroscopy
• Preparation of endoscopic injection of tissue adhesive

You may not qualify if:

• No esophageal gastric varices bleeding history;
• Esophageal varices or gastric varices which temporarily won't be treated by endoscopic therapy;
• The cefotiam contraindications: such as allergies, pregnancy etc;
• Patients with the other malignant tumor except liver cancer;
• The preoperative diagnosis of infection;
• The large amount of ascites;
• The acute bleeding period (\< 5 days);
• Patients refused to participate in the study.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Esophageal and Gastric Varices; Fibrosis

Interventions

Cefotiam

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hypertension, Portal; Liver Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Shiyao Chen, Professor

  Shanghai Zhongshan Hospital

  STUDY DIRECTOR

Central Study Contacts

Shiyao Chen, Professor

CONTACT

86-13601767310; chen.shiyao@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of department of Gastroenterology, Zhongshan Hospital

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: February 29, 2016
• Study Start: February 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: September 1, 2017
• Last Updated: January 6, 2017

Record last verified: 2017-01

Locations

CN (1)