UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050513 |
|---|---|
| Receipt number | R000057432 |
| Scientific Title | An observational study to evaluate the efficacy of suturing mucosal defects post duodenal endoscopic submucosal dissection |
| Date of disclosure of the study information | 2023/03/07 |
| Last modified on | 2023/07/31 11:05:08 |
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Basic information
Public title
An observational study to evaluate the efficacy of suturing mucosal defects post duodenal endoscopic submucosal dissection
Acronym
Suturing study post duodenal ESD
Scientific Title
An observational study to evaluate the efficacy of suturing mucosal defects post duodenal endoscopic submucosal dissection
Scientific Title:Acronym
Suturing study post duodenal ESD
Region
| Japan |
Condition
Condition
superficial non-ampullary duodenal epithelial tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine whether suturing of post-ESD mucosal defects on the anal side of the descending duodenum, which can be affected by pancreatic juice and bile exposure, can reduce the risk of delayed complications such as bleeding and perforation, and to determine the cost-effectiveness of this procedure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of delayed adverse events (bleeding, perforation) within 28 days postoperatively
Key secondary outcomes
(1) Postoperative outcomes
rate of delayed bleeding
rate of delayed perforation
rate of surgery due to adverse events
rate of maintenance of complete sutures and the number of remaining clips at the second-look endoscopy 3-5 days after surgery
(2) Healthcare economics
length of hospital stay
total medical cost of hospitalization
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)The lesion is located anal side than descending part of duodenum (lesions crossing the superior duodenal angle can be included).
(2)The lesion size is less than 50 mm at preoperative evaluation.
(3)Endoscopically suspected adenoma or adenocarcinoma (preoperative biopsy not required)
(4)No endoscopic findings suggestive of submucosal invasion
(5)Patients aged 20 to 85 years at the time of obtaining consent
(6)Patients who give written consent to participate in this study
Key exclusion criteria
(1) Patients with familial adenomatous polyposis (FAP)
(2) Patients who are treated for multiple lesions at the same time (patients with multiple lesions, including those of other organs, can be included if only one lesion is treated during the protocol treatment period)
(3) Patients with history of duodenal resection in the past
(4) Patients with a distance of 10 mm or less between the lesion and the duodenal papilla or accessory papilla
(5) Patients whose lesions involve the duodenal bulb on the oral side
(6) Vital organ insufficiency (heart, lung, liver, kidney, bone marrow)
(7) Patients who cannot be managed perioperatively with antithrombotic drugs according to the guidelines proposed by Japan Gastroenterological Endoscopy Society
(8) Other patients considered by the attending physician to be ineligible for entry
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Motohiko |
| Middle name | |
| Last name | Kato |
Organization
Keio University School of Medicine
Division name
Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
motohikokato@keio.jp
Public contact
Name of contact person
| 1st name | Kurato |
| Middle name | |
| Last name | Miyazaki |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
k.miyazaki30417@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Olympus Corporation
Century Medical Corporation
MC Medical Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
| 2023 | Year | 03 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 02 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will perform this study to determine whether suturing of post-ESD mucosal defects on the anal side of the descending duodenum, which can be affected by pancreatic juice and bile exposure, can reduce the risk of delayed complications such as bleeding and perforation, and to determine the cost-effectiveness of this procedure.
Management information
Registered date
| 2023 | Year | 03 | Month | 06 | Day |
Last modified on
| 2023 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057432
