NCT03045783

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
912

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 7, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

February 7, 2017

Status Verified

February 1, 2017

Enrollment Period

2.2 years

First QC Date

January 4, 2017

Last Update Submit

February 4, 2017

Conditions

Gastric VaricesCirrhosis

Keywords

gastric varicesendoscopic 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 (5)

  • Rebleeding rate

    2 months

  • Mortality rate

    2 months

  • All clinical events

    2 months

  • 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

Study Arms (2)

Prophylactic use of antibiotics group

EXPERIMENTAL

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

Drug: Cefotiam

On-demand group

NO INTERVENTION

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

Interventions

CefotiamDRUG

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

Also known as: HaiTiShu
Prophylactic use of antibiotics group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

180 Fenglin Road

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Esophageal and Gastric VaricesFibrosis

Interventions

Cefotiam

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesHypertension, PortalLiver DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CefotaximeCephacetrileCephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Shiyao CHEN, M.D.

    Zhongshan Hospital, Fudan University, Shanghai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 4, 2017

First Posted

February 7, 2017

Study Start

December 1, 2016

Primary Completion

March 1, 2019

Study Completion

July 1, 2019

Last Updated

February 7, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)