Esophageal CancerNCT03492827
Evaluation of the Preventive Effect of Chlorhexidine Acetate Gargle for Upper Gastrointestinal Tract Infection After ESD
A study testing chlorhexidine acetate gargle in people with Esophageal Cancer and Gastric Cancer, run by Peking University Third Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophageal Cancer, Gastric Cancer
- What is being tested?
- chlorhexidine acetate gargle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of early gastrointestinal cancer or high grade intraepithelial neoplasia
- In line with endoscopic ESD treatment indications
- No limitation of age
Who cannot join
- Patients do not agree with gargling
- The patient requested surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100000
Yonghui Huang, archiater, 13911765322, pskyq@163.com
About this study
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.
Read more
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
- 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.
- 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.
Read the detailed description
The investigator proposed to gargle patients with chlorhexidine acetate before ESD to improve the oral microenvironment and reduce the pathogenic bacteria in the oral cavity. The main 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.
Patients and Methods:
Patients:
Inclusion criteria:
- Diagnosis of early gastrointestinal cancer
- in line with endoscopic ESD treatment indications
- no limitation of age
Exclusion criteria:
- patients do not agree with the mouthwash
- The patient requested surgery
Methods
Screening and enrollment:
- Patients with early-stage upper gastrointestinal cancer diagnosed endoscopically in the ivestigator's hospital.
- ESD indications evaluation: endoscopic ultrasonography was used to assess the depth of lesion infiltration and surrounding lymph nodes. Abdominal or chest CT was used to further evaluate local lymph nodes and distant metastases.
- Patients with indications for treatment sign informed consent
Treatment programs:
- After the patient signed the informed consent, they will be divided into the experimental group and control group according to random envelopes in accordance with the sequence of patients were admitted. Patients in the treatment group are given twice daily three days before endoscopic treatment.Patients in the controlled group will not receive gargle.
- Treatment of second-generation cephalosporins or levofloxacin (allergic cephalosporins) intravenously half an hour before ESD procedure to prevent infection.
- The main steps of ESD include: marking around the lesion, submucosal injection to fully lift of the lesion, cutting the mucosa around the circumference, submucosal peeling to completely separate the submucosa and the muscularis propria to achieve a complete resection of the lesion, and checking the wound surface vessels and lesions.
- Monitor blood routine and body temperature changes on the first and third days after treatment. If there are signs of infection in the clinic, monitor PCT and add appropriate antibiotics.
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
- Being tested
- chlorhexidine acetate gargle
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chlorhexidine acetate gargleDrug
observe whether it can achieve the effect of preventing postoperative infection
| Study group | Role | What they receive |
|---|---|---|
| gargle group | Experimental | drugs，chlorhexidine acetate gargle dosage，15ml，twice daily， duration，3days before ESD Receives: Drug: chlorhexidine acetate gargle |
| Control group | No intervention | Control group will not be interventioned with gargle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 hours after ESD procedure
Secondary outcomes (1)
infection rate 72 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
Measured: 72 hours after ESD procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start1 Jun 2017
- Primary completionJun 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huang Yonghui, Peking University Third Hospital
- Investigators
- Yonghui Huang, MD, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492827
- Sponsor's protocol ID
- LM2017252
- Status last verified
- Mar 2018
- First submitted
- 20 Mar 2018
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Preventive Effect of Chlorhexidine Acetate Gargle for Upper Gastrointestinal Tract Infection After ESD
- ClinicalTrials.gov ID
- NCT03492827
- Acronym / sponsor ID
- LM2017252
- Conditions
- Esophageal Cancer, Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 10 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
Detailed description
The investigator proposed to gargle patients with chlorhexidine acetate before ESD to improve the oral microenvironment and reduce the pathogenic bacteria in the oral cavity. The main 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.
Patients and Methods:
Patients:
Inclusion criteria:
- Diagnosis of early gastrointestinal cancer
- in line with endoscopic ESD treatment indications
- no limitation of age
Exclusion criteria:
- patients do not agree with the mouthwash
- The patient requested surgery
Methods
Screening and enrollment:
- Patients with early-stage upper gastrointestinal cancer diagnosed endoscopically in the ivestigator's hospital.
- ESD indications evaluation: endoscopic ultrasonography was used to assess the depth of lesion infiltration and surrounding lymph nodes. Abdominal or chest CT was used to further evaluate local lymph nodes and distant metastases.
- Patients with indications for treatment sign informed consent
Treatment programs:
- After the patient signed the informed consent, they will be divided into the experimental group and control group according to random envelopes in accordance with the sequence of patients were admitted. Patients in the treatment group are given twice daily three days before endoscopic treatment.Patients in the controlled group will not receive gargle.
- Treatment of second-generation cephalosporins or levofloxacin (allergic cephalosporins) intravenously half an hour before ESD procedure to prevent infection.
- The main steps of ESD include: marking around the lesion, submucosal injection to fully lift of the lesion, cutting the mucosa around the circumference, submucosal peeling to completely separate the submucosa and the muscularis propria to achieve a complete resection of the lesion, and checking the wound surface vessels and lesions.
- Monitor blood routine and body temperature changes on the first and third days after treatment. If there are signs of infection in the clinic, monitor PCT and add appropriate antibiotics.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gargle group | Experimental | Drug: chlorhexidine acetate gargledrugs，chlorhexidine acetate gargle dosage，15ml，twice daily， duration，3days before ESD |
| Control group | No intervention | –Control group will not be interventioned with gargle |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of early gastrointestinal cancer or high grade intraepithelial neoplasia
- In line with endoscopic ESD treatment indications
- No limitation of age
Key exclusion criteria (2 listed)
- Patients do not agree with gargling
- The patient requested surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chlorhexidine acetate gargleobserve whether it can achieve the effect of preventing postoperative infection | Drug | gargle group |
Primary outcome
infection rate 8 hours after ESD
Time frame: 8 hours after ESD procedure
infection is defined as temperature is higher than 38.5℃，WBC is higher than 10000/mm3，PCT is higher than 0.5ng/ml
1 secondary outcome
infection rate 72 hours after ESD
Time frame: 72 hours after ESD procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
Related trials for Esophageal Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yonghui Huang, MD study director
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chlorhexidine acetate gargle in people with Esophageal Cancer and Gastric Cancer, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yonghui Huang, MD (86-10-13911765322, 13911765322@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
infection rate 8 hours after ESD (time frame: 8 hours after ESD procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2018.