UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056976 |
|---|---|
| Receipt number | R000065077 |
| Scientific Title | A Randomized Controlled Trial on the Effectiveness of Prophylactic Antibiotics in Gastric Endoscopic Submucosal Dissection |
| Date of disclosure of the study information | 2025/02/07 |
| Last modified on | 2025/10/09 12:04:59 |
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Basic information
Public title
A Randomized Controlled Trial on the Effectiveness of Prophylactic Antibiotics in Gastric Endoscopic Submucosal Dissection
Acronym
Prophylactic Antibiotics in Gastric ESD: RCT
Scientific Title
A Randomized Controlled Trial on the Effectiveness of Prophylactic Antibiotics in Gastric Endoscopic Submucosal Dissection
Scientific Title:Acronym
Prophylactic Antibiotics in Gastric ESD: RCT
Region
| Japan |
Condition
Condition
gastric tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of prophylactic antibiotics on the incidence of post-ESD coagulation syndrome (PECS) in gastric endoscopic submucosal dissection (ESD) and to verify their effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of complications (PPS, pneumonia, post-procedural bleeding, delayed perforation) after gastric ESD.
Key secondary outcomes
Frequency of side effects associated with antibiotic administration (rash, diarrhea, anaphylactic reactions, etc.)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Prophylactic Antibiotic Administration Group
Medication used: Ampicillin + Sulbactam (injectable),3g per dose
Administration schedule: Intravenous injection three times
1 hour before surgery
8 hours after the initial dose
16 hours after the initial dose
Interventions/Control_2
Non-antibiotic group (untreated control)
No prophylactic antibiotics will be administered, and standard post-ESD management will be provided.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 years or older at registration
Diagnosed with gastric cancer and scheduled for endoscopic treatment (endoscopic treatment eligibility according to the gastric cancer guidelines)
Adenomas (size not specified)
Other tumor-like lesions (such as neuroendocrine tumors) diagnosed or suspected, and scheduled for ESD
Key exclusion criteria
Patients who develop multiple ESD-induced ulcers simultaneously
Patients with a gastric tube or post-surgical stomach
Patients with an allergy to antibiotics (Ampicillin/Sulbactam)
Patients with a history of hypersensitivity to penicillin antibiotics
Patients diagnosed with infectious mononucleosis
Patients requiring heparinization (oral anticoagulants are acceptable according to the guidelines of the Endoscopic Society)
Patients who regularly take analgesics
Pregnant patients
Patients undergoing maintenance dialysis
Patients taking steroid medications
Patients with cognitive dysfunction making it difficult to participate in the trial
Patients deemed unsuitable for the trial by the physician's judgment
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | TAKASHI |
| Middle name | |
| Last name | IBUKA |
Organization
Gifu University Hospital
Division name
Department of Gastroenterology
Zip code
501-1194
Address
1-1 Yanagido, Gifu City, Gifu Prefecture, Japan
TEL
058-230-6000
th_newword@yahoo.co.jp
Public contact
Name of contact person
| 1st name | HIROKI |
| Middle name | |
| Last name | TANIGUCHI |
Organization
Gifu University Hospital
Division name
Department of Gastroenterology
Zip code
501-1194
Address
1-1 Yanagido, Gifu City, Gifu Prefecture, Japan
TEL
058-230-6000
Homepage URL
th_newword@yaoo.co.jp
Sponsor or person
Institute
Gifu University Hospital
Institute
Department
Personal name
Funding Source
Organization
No external funding source
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gifu University Graduate School of Medicine Ethics Review Committee for Medical Research
Address
1-1 Yanagido, Gifu City, Gifu Prefecture, Japan
Tel
058-230-6059
rinri@t.gifu-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
200
Results
Two hundred patients who underwent gastric ESD were randomized to antibiotic (ampicillin-sulbactam) and non-antibiotic groups. The incidence of PECS was significantly lower in the antibiotic group (41.3% vs 57.3%, p=0.031). However, tumor location differed, and after adjustment the effect was not significant (adjusted OR 0.64, p=0.15). WBC change on POD1 was lower in the antibiotic group, while CRP and recovery were similar. One mild diarrhea case resolved spontaneously. No clear benefit was shown.
Results date posted
| 2025 | Year | 10 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The per-protocol population consisted of 181 patients (92 in the antibiotic group and 89 in the non-antibiotic group).
Baseline characteristics, including age, sex, body mass index (BMI), preoperative inflammatory markers (CRP and WBC), tumor size, macroscopic type, and ulcerative findings, were generally well balanced between groups.
However, tumor location differed significantly, with upper-third gastric lesions being more frequent in the non-antibiotic group (U/M/L = 24/42/23 vs. 7/61/24, p = 0.002).
Participant flow
Of 237 patients assessed for eligibility, 37 were excluded due to refusal to participate or ineligibility, leaving 200 patients who were randomized equally to the antibiotic group (n = 100) and the non-antibiotic group (n = 100).
After exclusions for post-randomization ineligibility and protocol deviations, 97 and 94 patients were included in the full analysis set, and 92 and 89 patients in the per-protocol set for the antibiotic and non-antibiotic groups, respectively.
Adverse events
One case of mild diarrhea was observed in the antibiotic group, which resolved spontaneously after completion of antibiotic therapy.
No serious adverse events, including drug-related rashes, were observed in either group.
Outcome measures
Primary Outcome:
The primary outcome was the incidence of post-ESD coagulation syndrome (PECS), defined as the presence of any of the following on postoperative day 1 without perforation or pneumonia: fever >=37.6C, abdominal pain (VAS >=5/10), white blood cell count >=10000/uL, or C-reactive protein (CRP) >=0.5 mg/dL.
Secondary Outcomes:
Changes in WBC and CRP levels, postoperative pain (VAS), time to oral intake, length of hospital stay, and incidence of adverse events.
Plan to share IPD
There is no plan to share individual participant data (IPD).
Only anonymized, aggregated data will be disclosed through conference presentations and journal publications.
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 02 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2025 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 07 | Day |
Last modified on
| 2025 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065077
