Evaluation of the Preventive Effect of Chlorhexidine Acetate Gargle for Upper Gastrointestinal Tract Infection After ESD

NCT03492827 | Unknown

• 1 other identifier: LM2017252
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 1

Brief Summary

Backgrounds： With the continuous improvement of sterilization and endoscopic structure, the infection caused by endoscopy has gradually declined.With the rapid development of digestive endoscopic therapy in the past decade, therapeutic endoscopy has been widely carried out worldwide. These techniques have caused the mucous membrane or deeper damage to achieve the goal of curing the disease. During therapeutic endoscopic procedures, endogenous bacteria may be ectopic to the blood circulation due to mucosal or deeper damage. The endoscope is used to in and out lumens multiple times, and the injections are injected into the tissues through the accessories. These processes may bring the pathogenic bacteria from the patient's mouth into the digestive tract through the endoscope and enter the blood through the damaged mucosa. In addition, bacteremia associated with endoscopic procedures may cause bacterial infections in distant organs (eg infective endocarditis). Postoperative infection rates can reach 12-22% . The results of the etiological culture show that it is consistent with the bacteria of oral bacteria. It is possibly related to multiple passage into the digestive tract of endoscopic and accessory . However, the endoscopic operation process will inevitably lead to subsequent infections. ESD treatment involves endoscopic multiple access to the upper digestive tract through the mouth, attachments and injection needles and other multiple exposure to the wound, so the probability of postoperative infection is significantly higher than the average endoscope. Investigators proposed to gargle patients with chlorhexidine acetate before ESD to improve the oral microenvironment and reduce the pathogenic bacteria in the oral cavity, so as to observe whether it can achieve the effect of preventing postoperative infection. Methods and patients

1. 1.Objectives: This study is a prospective randomized controlled study in single center of Peking University Third Hospital. The purpose of the study is to evaluate the preventive effect of chlorhexidine acetate gargle on the infection of early upper gastrointestinal cancer after endoscopic ESD therapy.
2. 2.Calculation of sample size: According to the postoperative infection rate of 10%, 25% improvement is given after the gargle is administered, and the error range is calculated at 2%. The sample size needs 306 cases.

Conditions

Esophageal Cancer; Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• infection rate 8 hours after ESD

  infection is defined as temperature is higher than 38.5℃，WBC is higher than 10000/mm3，PCT is higher than 0.5ng/ml

  8 hours after ESD procedure

Secondary Outcomes (1)

• infection rate 72 hours after ESD

  72 hours after ESD procedure

Other Outcomes (1)

• complications of ESD

  within 7 days after ESD

Study Arms (2)

gargle group

EXPERIMENTAL

drugs，chlorhexidine acetate gargle dosage，15ml，twice daily， duration，3days before ESD

Drug: chlorhexidine acetate gargle

Control group

NO INTERVENTION

Control group will not be interventioned with gargle

Interventions

chlorhexidine acetate gargle DRUG

observe whether it can achieve the effect of preventing postoperative infection

gargle group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of early gastrointestinal cancer or high grade intraepithelial neoplasia
• In line with endoscopic ESD treatment indications
• No limitation of age

You may not qualify if:

• Patients do not agree with gargling
• The patient requested surgery

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Yonghui Huang, MD

  Peking University Third Hospital

  STUDY DIRECTOR

Central Study Contacts

Yonghui Huang, MD

CONTACT

86-10-13911765322; 13911765322@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director of Gastroenterology department

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: April 10, 2018
• Study Start: June 1, 2017
• Primary Completion: June 1, 2019
• Study Completion: September 1, 2019
• Last Updated: April 10, 2018

Record last verified: 2018-03

Locations

CN (1)