UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033674 |
|---|---|
| Receipt number | R000038392 |
| Scientific Title | A proper sedation/analgesia to enhance safety in endoscopic submucosal dissection for early gastric cancer or superficial esophageal cancer |
| Date of disclosure of the study information | 2018/09/01 |
| Last modified on | 2023/08/15 12:35:33 |
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Basic information
Public title
A proper sedation/analgesia to enhance safety in endoscopic submucosal dissection for early gastric cancer or superficial esophageal cancer
Acronym
A proper anesthesia for endoscopic submucosal dissection
Scientific Title
A proper sedation/analgesia to enhance safety in endoscopic submucosal dissection for early gastric cancer or superficial esophageal cancer
Scientific Title:Acronym
A proper anesthesia for endoscopic submucosal dissection
Region
| Japan |
Condition
Condition
early gastric cancer/superficial esophageal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to establish a guideline selecting safe and effective way of sedation/analgesia in endoscopic submucosal dissection for early gastric cancer or superficial esophageal cancer.
Basic objectives2
Others
Basic objectives -Others
Evaluation of the difference among the methods of anesthesia with respect to the procedural completeness of ESD and the frequency and severity of complications.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The procedural completeness of ESD (completion rate of ESD in block and histological margin in vertical and horizontal directions on 2 weeks after ESD)
Key secondary outcomes
The frequency and severity of complications (Bleeding, perforation, aspiration pneumonia, respiratory suppression, circular disturbance, cognitive ability, and factors affecting those complications on discharge)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Intravenous anesthesia without intubation (during ESD procedure)
Interventions/Control_2
Systemic anesthesia without intubation (during ESD procedure)
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
Early gastric cancer
Absolute indication; differentiated adenocarcinoma in situ no larger than 2 cm in diameter without ulcer formation
Relative indication;
i) Absolute indication over 2 cm in diameter
ii) Absolute indication less than 3 cm with ulcer formation
iii) Absolute indication, but poorly differentiated adenocarcinoma
Superficial esophageal cancer
Absolute indication; squamous cell carcinoma invading no deeper than the submucosa and less than two-thirds of circumference
Relative indication;
i) Absolute indication extending two-thirds of circumference or more
ii) squamous cell carcinoma invading down to 1000 micro meter of submucosal layer
Key exclusion criteria
No indication of general anesthesia
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Hoshi |
Organization
Institute of Community Medicine, Niigata University Medical and Dental Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
949-7302
Address
4132 Urasa, Minami Uonuma, Niigata
TEL
81-25-777-3200
thoshi0725@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Suda |
Organization
Institute of Community Medicine, Niigata University Medical and Dental Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
949-7302
Address
4132 Urasa, Minami Uonuma, Niigata
TEL
81-25-777-3200
Homepage URL
tspitt@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Niigata University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, Institute of Community Medicine, Niigata University Hospital
Address
4132 Urasa, Minami Uonuma, Niigata
Tel
025-777-3200
tspitt@med.niigata-u.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
魚沼基幹病院（新潟県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 01 | 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
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 08 | Day |
Last modified on
| 2023 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038392
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