UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035178 |
|---|---|
| Receipt number | R000040093 |
| Scientific Title | Performance of Preoperative Antibiotics for Post-ESD coagulation syndrome |
| Date of disclosure of the study information | 2018/12/12 |
| Last modified on | 2021/12/14 17:13:58 |
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Basic information
Public title
Performance of Preoperative Antibiotics for Post-ESD coagulation syndrome
Acronym
PPAP trial
Scientific Title
Performance of Preoperative Antibiotics for Post-ESD coagulation syndrome
Scientific Title:Acronym
PPAP trial
Region
| Japan |
Condition
Condition
colorectal epithelial neoplasm equal or larger than 20mm
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of preoperative antibiotics for colorectal endoscopic submucosal dissection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of post electrocoagulation syndrome after colorectal endoscopic submucosal dissection
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Antibiotics
Interventions/Control_2
Without antibiotics
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) colorectal epithelial neoplasm equal or larger than 20mm
2) Only one lesion is performed endoscopic submucosal dissection.
Key exclusion criteria
1) allergy to penicillin
2) pregnancy
3) Antiplatelets except low dose aspirin can not be stopped during endoscopic treatment.
4) During steroid therapy
5) The lesion invades appendix orifice, diverticulum, or ileum
6) Circumferencial lesion
Target sample size
431
Research contact person
Name of lead principal investigator
| 1st name | Yoji |
| Middle name | |
| Last name | Takeuchi |
Organization
Osaka International Cancer Institute
Division name
Department of Gastrointestinal Oncology
Zip code
541-8567
Address
3-1-69, Otemae, Chuo-ku, Osaka, Japan
TEL
06-6945-1181
yoji.endoscopy@oici.jp
Public contact
Name of contact person
| 1st name | Satoki |
| Middle name | |
| Last name | Shichijo |
Organization
Osaka International Cancer Institute
Division name
Department of Gastrointestinal Oncology
Zip code
541-8567
Address
3-1-69, Otemae, Chuo-ku, Osaka, Japan
TEL
06-6945-1181
Homepage URL
7satoki@oici.jp
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
Funding Source
Organization
Endoscopic Device Selection Conference in Kansai
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
Review board, Osaka International Cancer Institute
Address
3-1-69, Otemae, Chuo-ku, Osaka
Tel
81669451181
rinri01@opho.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
| 2018 | Year | 12 | Month | 12 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Published
Result
URL related to results and publications
https://www.giejournal.org/article/S0016-5107(21)01617-5/fulltext
Number of participants that the trial has enrolled
432
Results
From February 5, 2019 to September 7, 2020, 432 patients were enrolled and assigned to the antibiotic
group (n = 216) or nonantibiotic group (n = 216). After withdrawal of 52 patients, 192 in the antibiotic group
and 188 in the nonantibiotic group were analyzed. PECS occurred in 9 of 192 patients (4.7%) in the antibiotic
group and 14 of 188 patients (7.5%) in the nonantibiotic group, with an odds ratio of .61 (95% confidence interval,
.23-1.56; P = .29).
Results date posted
| 2021 | Year | 12 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Background characteristics of patients (sex and location)
were comparable between the antibiotic and nonantibiotic
groups, including the number of patients taking
nonsteroidal anti-inflammatory drugs. Median
tumor size was 30 mm in both groups. Previous biopsy
samples of the lesions were performed in 52 (27%) and
42 (22%) patients in the antibiotic and nonantibiotic
groups, respectively. Three of these samples were local
recurrent lesions after endoscopic resection and the
others were naive tumor. No tumor on the anastomosis
site was included.
Participant flow
Trial recruitment was conducted from February 5, 2019
to September 7, 2020, and follow-up was completed on
October 8, 2020. Of 464 recruited patients, 32 declined
to participate were excluded, and 432 patients were
enrolled and assigned to either the antibiotic group
(n=216) or nonantibiotic group (n=216) at 21 Japanese
tertiary institutions.
Adverse events
Perforation occurred in 10 patients (5.0%, 8 intraprocedural and 2 delayed perforations) in the antibiotic group
and in 12 patients (6.0%, 8 intraprocedural and 4 delayed
perforations) in the nonantibiotic group. All perforation
cases could be managed conservatively without surgical
intervention, and no significant difference was confirmed
between the 2 groups. Twelve patients
developed other adverse events (5.9%, 9 post-ESD
bleeding, 1 hemorrhoidal bleeding, 1 chronic cholecystitis,
and 1 reflux esophagitis) in the antibiotic group, and
adverse events occurred in 11 patients (5.5%, 7 post-ESDbleeding, 1 ileus, 1 bacteremia, 1 arrhythmia, and 1 cystitis)
in the nonantibiotic group (P =.83).
Outcome measures
PECS occurred in 9 of 192 patients (4.7%) in the antibiotic
group (interventional group) and 14 of 188 patients
(7.5%) in the nonantibiotic group, with an odds ratio of .61
(95% confidence interval [CI], .23-1.56; P = .29)
when analyzed by the PPS. By intention to treat analysis,
PECS occurred in 9 of 214 patients (4.2%) in the
antibiotic group and in 14 of 213 patients (6.6%) in the
nonantibiotic group, with an odds ratio of .62 (95% CI,
.27-1.44; P = .29). White blood cell counts on the day
after ESD were 7400 cells/mL and 8100
cells/mL in the antibiotic and nonantibiotic groups,
respectively (P < .001). The time from ESD to discharge
was 3.4 days (95% CI, 3.2-3.6) and 3.6 days (95% CI, 3.3-
3.8) in the antibiotic and nonantibiotic groups,
respectively (P = .39).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 28 | Day |
Date of closure to data entry
| 2020 | Year | 10 | Month | 28 | Day |
Date trial data considered complete
| 2020 | Year | 10 | Month | 28 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 08 | Day |
Last modified on
| 2021 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040093
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2020/10/28 | PPAP trial：UMIN固定用シート別(20201027).xlsx |
