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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033674
Receipt No. 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 2018/08/08

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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
Middle name
Last name Takahiro Hoshi
Organization Institute of Community Medicine, Niigata University Medical and Dental Hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address 4132 Urasa, Minami Uonuma, Niigata 949-7302, Japan
TEL 81-25-777-3200
Email thoshi0725@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Suda
Organization Institute of Community Medicine, Niigata University Medical and Dental Hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address 4132 Urasa, Minami Uonuma, Niigata 949-7302, Japan
TEL 81-25-777-3200
Homepage URL
Email tspitt@med.niigata-u.ac.jp

Sponsor
Institute Niigata University
Institute
Department

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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2018 Year 08 Month 07 Day
Date of IRB
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
2018 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038392

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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