UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038049 |
|---|---|
| Receipt number | R000043371 |
| Scientific Title | Prospective study to analyze the efficacy of new electrocoagulation system (maXium) for preventing post-ESD Coagulation syndrome |
| Date of disclosure of the study information | 2019/09/18 |
| Last modified on | 2025/09/22 14:52:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
New electrocoagulation system for preventing post-ESD Coagulation syndrome
Acronym
NewPEC trial
Scientific Title
Prospective study to analyze the efficacy of new electrocoagulation system (maXium) for preventing post-ESD Coagulation syndrome
Scientific Title:Acronym
NewPEC trial
Region
| Japan |
Condition
Condition
colorectal adenoma, early colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze the efficacy of colorectal ESD with new electrocoagulation system (maXium) for preventing PECS
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Frequency of PECS
Key secondary outcomes
PECS frequency according to type and tumor location; The rate of delayed perforation, delayed bleeding and other complications;
Treatment time of ESD; En bloc resection rate; Elucidation for clinical features of PECS
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Colorectal adenoma or eraly colorectal cancer =< 5cm that will be treated with ESD
2. Age from 20 to 85 years old
3. Agreement with signed informed consent
Key exclusion criteria
1. Tumor size > 5cm
2. Cutting line will be into appendix, ileo-cecal valve or anus
3. Severe dysfunction of heart, lung and kidney
4. Poor status: Performance Status(ECOG) 3 or 4
5. VAS>20mm, BT>37.0(celsius) or WBC>normal range
6. Administration of steroid or pain killer
7. Administration of anti-cogulant drugs
8. Pregnancy
9. Inappropriateness with physician's judgement
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Takaya |
| Middle name | |
| Last name | Shimura |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Gastroenterology and Metabolism
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
TEL
052-853-8211
tshimura@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Takaya |
| Middle name | |
| Last name | Shimura |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Gastroenterology and Metabolism
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
TEL
052-853-8211
Homepage URL
tshimura@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Management Center, Nagoya City University Hospital
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
Tel
052-858-7215
clinical_research@med.nagoya-cu.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
名古屋市立大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 18 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1111/jgh.16444
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/jgh.16444
Number of participants that the trial has enrolled
104
Results
Ninety-one patients meeting the inclusion criteria were included in the final study analysis. The incidence of PECS was 16 percent, comprising type 1 (11 percent) and type 2 (5 percent) PECS. Simple extra-luminal air without PECS was observed in 7 percent of patients. Use of the maXium electrosurgical unit did not reduce the incidence of PECS after colorectal ESD; however, the maXium unit had equivalent performance to a conventional electrosurgical unit used for colorectal ESD.
Results date posted
| 2025 | Year | 09 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 12 | Month | 14 | Day |
Baseline Characteristics
Of the 91 patients included in the final analysis, right-sided colon cancer, including the ascending colon and cecum was 26 percent (24/92), and morphology was 31 percent in protruded type, 51 percent in flat type and 19 percent in depressed type. The median tumor size and resected specimen size was
22 mm and 33 mm, respectively. The final pathological diagnosis was sessile serrated lesion in 7 patients, adenoma in 47 patients, pTis CRC in 24 patients, and pT1 CRC in 13 patients.
Participant flow
During the study enrollment period from October 2019 to September 2021, 173 patients who underwent colorectal ESD were screened. Of these, 104 patients met the study inclusion criteria and were enrolled; however, 13 patients were excluded due to intra-ESD perforation, muscular damage, non-completion of ESD, or pT2 stage after ESD. Accordingly, a total of 91 patients were included in the final study analysis.
Adverse events
The incidence of PECS, which is primary endpoint of the present study, was 16 percent. The incidence of type 1 PECS and type 2 PECS was 11 percent and 5 percent, respectively. The upper limit of the 90 percent CI for the incidence of PECS was greater than 15 percent, which was the calculated threshold for adequate statistical power. All patients with PECS improved with conservative management which consisted of a few days of fasting and antibiotics administration. No patients with PECS required emergency surgery. One patient had delayed perforation and underwent emergency surgery. Simple extra-luminal air without PECS was observed in six patients (7 percent), however, no specific treatment was required.
Outcome measures
The incidence of PECS, which is primary endpoint of the present study, was 16 percent. The incidence of type 1 PECS and type 2 PECS was 11 percent and 5 percent, respectively. The upper limit of the 90 percent CI for the incidence of PECS was greater than 15 percent, which was the calculated threshold for adequate statistical power.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 09 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 23 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
PECS was defined as either of the following findings after ESD:
1. VAS >= 30 mm or a raise of VAS >= 20 mm from baseline VAS
2. BT >= 37.5 celsius
3. WBC >= 10,000/ul
type I PECS: PECS without extra-luminal air
type II PECS: PECS with peri-luminal air
CT scan for all enrolled cases after ESD
Management information
Registered date
| 2019 | Year | 09 | Month | 18 | Day |
Last modified on
| 2025 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043371
