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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047703
Receipt No. R000054276
Scientific Title Endoscopic hand-suturing (EHS) using a newly designed through the scope needle holder for mucosal defects after colorectal endoscopic submucosal dissection : a multicenter study
Date of disclosure of the study information 2022/05/15
Last modified on 2022/05/10

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Basic information
Public title Endoscopic hand-suturing (EHS) for mucosal defects after colorectal endoscopic submucosal dissection
Acronym Endoscopic hand-suturing (EHS) for mucosal defects after colorectal endoscopic submucosal dissection
Scientific Title Endoscopic hand-suturing (EHS) using a newly designed through the scope needle holder for mucosal defects after colorectal endoscopic submucosal dissection : a multicenter study
Scientific Title:Acronym Endoscopic hand-suturing (EHS) using a newly designed through the scope needle holder for mucosal defects after colorectal endoscopic submucosal dissection : a multicenter study
Region
Japan

Condition
Condition rectal cancer and sigmoid colon cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluate the suture retention on postoperative days 3-4 and suture time with a modified flexible needle holder.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Suture retention on postoperative days 3-4.
Suture time with a modified flexible needle holder.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Endoscopic hand suturing
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patient has a preoperative diagnosis of early-stage rectal cancer or sigmoid colon cancer (including suspected cancer) measuring 2-5 cm
2) Scheduled to undergo ESD
3) At least 20 years old
4) PS 0-1
5) Informed consent has been obtained.
Key exclusion criteria 1) Patients with a bleeding tendency (specifically if the following applies).
*Platelet count less than 50,000/mm3 or PT-INR 2 or higher under non-compliance with anticoagulants.
*Liver cirrhosis, Child-Pugh score B-C.
*Chronic renal failure needs dialysis.
2) Patients who are unable to withdraw antithrombotic medications based on the guidelines.
3) Post-ESD mucosal defects overlying the anal verge.
4) History of abdominal or pelvic surgical resection.
5) History of radiation to the abdominal or pelvic region.
6) Patients whose attending physician determines that participation in this study is inappropriate.
Target sample size 23

Research contact person
Name of lead principal investigator
1st name Yutaka
Middle name
Last name Saito
Organization National Cancer Center Hospital
Division name Endoscopy Division
Zip code 104-0045
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL 0335422511
Email ytsaito@ncc.go.jp

Public contact
Name of contact person
1st name Takeshi
Middle name
Last name Uozumi
Organization National Cancer Center Hospital
Division name Endoscopy Division
Zip code 104-0045
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL 0335422511
Homepage URL
Email tuozumi@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization Japan Consortium for Advanced Surgical Endoscopy
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Shizuoka Cancer Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Cancer Center Institutional Review Board
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
Tel 0335422511
Email ncch-irb@ml.res.ncc.go.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
2022 Year 05 Month 15 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 Preinitiation
Date of protocol fixation
2022 Year 04 Month 22 Day
Date of IRB
2022 Year 05 Month 07 Day
Anticipated trial start date
2022 Year 05 Month 10 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 05 Month 10 Day
Last modified on
2022 Year 05 Month 10 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054276

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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