Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02693951
Other study ID # CSY-LCF-2016
Secondary ID
Status Recruiting
Phase N/A
First received February 18, 2016
Last updated January 4, 2017
Start date February 2016
Est. completion date September 2017

Study information

Verified date January 2017
Source Shanghai Zhongshan Hospital
Contact Shiyao Chen, Professor
Phone 86-13601767310
Email chen.shiyao@zs-hospital.sh.cn
Is FDA regulated No
Health authority China: National Health and Family Planning Commission
Study type Interventional

Clinical Trial 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.


Description:

At present, there is still a controversy about the application of antibiotics in the treatment of patients with non acute hemorrhage of esophageal varices. This study is a randomized controlled trial. Patients randomly enter two treatment groups:

1. the prophylactic use of antibiotics group

and

2. the non-prophylactic use of antibiotics group

Treatment allocation is by block randomization with an equal number for both groups. The incidence of infection after endoscopic treatment will be analyzed.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date September 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

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

Locations

Country Name City State
China Shanghai Zhongshan Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The incidence of infection after endoscopic treatment Patients will receive body temperature, blood routine, inflammatory markers examination before and after endoscopic treatment. 1 week No
Secondary Rebleeding rate Patients will receive an endoscopic examination after patients have been followed up for 2 months. 2 months No
Secondary Mortality rate The investigators observe the mortality events during 2 months 2 months No
See also
  Status Clinical Trial Phase
Completed NCT01884415 - Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis Phase 3
Recruiting NCT05014594 - Sodium-glucose Linked Transporter 2 (SGLT-2) Inhibitors in Recurrent Ascites: a Pilot RCT Phase 2
Not yet recruiting NCT03631147 - The Effect of Rifaximin on Portal Vein Thrombosis N/A
Completed NCT04939350 - Evaluation of the Vaccination Coverage of Cirrhotic Patients Followed in the General Hospitals in France in 2021
Completed NCT02528760 - To Determine the Role of Prokinetics in Feed Intolerance in Critically Ill Cirrhosis N/A
Recruiting NCT05484206 - Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434 Phase 1
Not yet recruiting NCT05538546 - Baveno VI Criteria in Dynamic Monitoring of High-risk Varices in Compensated Cirrhotic Patients
Not yet recruiting NCT04053231 - Hepatocarcinoma Recurrence on the Liver Study - Part2
Recruiting NCT02983968 - Use of the French Healthcare Insurance Database
Completed NCT02705534 - Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1 Phase 3
Completed NCT02596880 - Sofosbuvir, Daclatasvir, Ribavirin for Hepatitis C Virus (HCV) Cirrhotics Phase 3
Completed NCT02247414 - Warfarin Prevents Portal Vein Thrombosis in Patients After Laparoscopic Splenectomy and Azygoportal Disconnection Phase 4
Completed NCT02016196 - Rifaximin vs Placebo for the Prevention of Encephalopathy in Patients Treated by TIPS Phase 3
Withdrawn NCT01956864 - Study of High-Dose Oral Vitamin D for the Prevention of Liver Cancer Phase 1
Completed NCT01362855 - Advance Care Planning Evaluation in Hospitalized Elderly Patients
Completed NCT01447537 - Mechanisms Involved in the Benefits of an Exercise Programme in Patients With Cirrhosis N/A
Completed NCT02113631 - Comparative Effectiveness and Tolerability of Boceprevir vs Telaprevir N/A
Active, not recruiting NCT01205074 - ¹³C-Methacetin Breath Test (MBT) Methodology Study Phase 2/Phase 3
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Completed NCT01231828 - Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies. N/A