UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052033 |
|---|---|
| Receipt number | R000058649 |
| Scientific Title | Endoscopic submucosal dissection for colorectal tumors as day surgery |
| Date of disclosure of the study information | 2023/08/29 |
| Last modified on | 2023/08/29 05:58:32 |
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Basic information
Public title
Endoscopic submucosal dissection for colorectal tumors as day surgery
Acronym
Endoscopic submucosal dissection for colorectal tumors as day surgery
Scientific Title
Endoscopic submucosal dissection for colorectal tumors as day surgery
Scientific Title:Acronym
Endoscopic submucosal dissection for colorectal tumors as day surgery
Region
| Japan |
Condition
Condition
Colorectal tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether endoscopic submucosal dissection for colorectal tumors can be performed safely as a day procedure in a single-arm prospective study.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Readmission rate
Key secondary outcomes
Rate of adverse event (posterior hemorrhage, delayed perforation, PECS, others)
Risk factor analysis for adverse event and readmission
Patient Satisfaction
Patient survey: 1) Satisfaction with this day surgery 2) If similar surgery is needed next time, would you prefer day surgery 3) Any problems
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with a pretreatment endoscopic diagnosis of colorectal adenoma of 20 mm or more or early-stage colorectal cancer with a suspected depth of submucosal slight invasion.
All of the following requirements are met.
1) The patient is between 18 and 80 years of age at the time of registration.
2) PS (ECOG) is either 0 or 1.
3) The most recent blood collection laboratory tests within 30 days prior to study enrolment meet all of the following (no blood transfusion within 14 days prior to the blood collection used for enrolment).
1. hemoglobin > 9 g/dL
2. platelets >100,000/mm3
3. AST and ALT < 100
4. serum creatinine < 2.0 mg/dL
4) It is possible to follow the patient for 30 days after treatment.
5) Written consent to participate in the study has been obtained
6) Have an adult living with them at home and be able to come to the hospital within 2 hours.
Key exclusion criteria
1) Has undergone endoscopic treatment for a lower gastrointestinal lesion within 30 days prior to enrolment.
2) Scheduled endoscopic treatment of lower gastrointestinal lesions within 30 days of enrolment.
3) Women of childbearing potential, pregnant or lactating.
4) Complicated psychiatric symptoms and lack of good understanding of the study.
5) History of myocardial infarction or unstable angina within 3 months.
6) Patients with coagulopathies.
7) With active bacterial and fungal infections (fever above 38.5, complicated by bacterial infectivity on imaging or bacteriological examination).
8) Complicated respiratory disease requiring continuous oxygen administration.
9) On dialysis.
10) Positive COVID-19 antigen test or PCR test, e.g. in advance. No symptoms are required.
11) Complicated by poorly controlled hypertension.
12) Other cases in which participation in the study is deemed unjustified by the physician in charge.
13) Cases with a preoperative endoscopic diagnosis of more than 3/4 circumference or more than 10 cm in length, extension into or proximity to the appendiceal orifice or diverticulum, requiring ESD treatment of the orifice or diverticulum area.
14) Sporadic localized tumors with a background of chronic inflammation such as ulcerative colitis, DALM
15) Local residuals after endoscopic resection, postoperative anastomotic lesions
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Ohata |
Organization
NTT medical center Tokyo
Division name
Department of Gastrointestinal Endoscopy
Zip code
141-0022
Address
5 Chome-9-22 Higashigotanda, Shinagawa City, Tokyo
TEL
03-3448-6111
ken.ohata1974@gmail.com
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Minato |
Organization
NTT medical center Tokyo
Division name
Department of Gastrointestinal Endoscopy
Zip code
141-0022
Address
5 Chome-9-22 Higashigotanda, Shinagawa City, Tokyo
TEL
03-3448-6111
Homepage URL
yoheiminato55925@gmail.com
Sponsor or person
Institute
NTT medical center Tokyo
Institute
Department
Personal name
Yohei Minato
Funding Source
Organization
None
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
NTT medical center Tokyo Ethics Committee
Address
5 Chome-9-22 Higashigotanda, Shinagawa City, Tokyo
Tel
0334486111
yoheiminato55925@gmail.com
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
NTT東日本関東病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 29 | 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
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Endoscopic submucosal dissection for colorectal tumors as day surgery
Management information
Registered date
| 2023 | Year | 08 | Month | 29 | Day |
Last modified on
| 2023 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058649
