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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036323
Receipt No. R000041364
Scientific Title An enhanced recovery protocol of oral intake could improve nutritional status in patients after endoscopic submucosal dissection for esophageal or gastric neoplasms.
Date of disclosure of the study information 2019/04/01
Last modified on 2020/09/27

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Basic information
Public title An enhanced recovery protocol of oral intake could improve nutritional status in patients after endoscopic submucosal dissection for esophageal or gastric neoplasms.
Acronym An enhanced recovery protocol of oral intake could improve nutritional status in patients after endoscopic submucosal dissection for esophageal or gastric neoplasms.
Scientific Title An enhanced recovery protocol of oral intake could improve nutritional status in patients after endoscopic submucosal dissection for esophageal or gastric neoplasms.
Scientific Title:Acronym An enhanced recovery protocol of oral intake could improve nutritional status in patients after endoscopic submucosal dissection for esophageal or gastric neoplasms.
Region
Japan

Condition
Condition esophageal or gastric neoplasms
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Our aim is to verify whether an enhanced recovery protocol of oral intake could improve nutritional status in patients after endoscopic submucosal dissection for esophageal or gastric neoplasms
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes effect on nutritional status a week after endoscopic submucosal dissection
Key secondary outcomes rate of post-ESD bleeding, rate of ulcer healing 6 weeks after endoscopic submucosal dissection, effect on patients' satisfaction, effect on dietary intake

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 conventional diet form after endoscopic submucosal dissection
Interventions/Control_2 enhanced recovery of oral intake after endoscopic submucosal dissection
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 patients who will undergo endoscopic submucosal dissection for esophageal or gastric neoplasms
Key exclusion criteria (1)a lesion with active gastroduodenal ulcer
(2)a lesion in the remnant stomach
(3)a recurrent lesion after for esophageal or gastric neoplasms
(4)use of dual antiplatelet therapy
(5)severe anemia
(6)severe liver damage or liver cirrhosis
(7)severe renal dysfunction or hemodialysis
(8)oral administration of steroid or immunosuppressive drug
(9)hypersensitivity to vonoprazan
(10)informed consent was not obtained
(11)pregnancy or nursing
(12)inadequacy judged by investigators



Target sample size 50

Research contact person
Name of lead principal investigator
1st name Naoto
Middle name
Last name Iwai
Organization Fukuchiyama City Hospital

Division name Department of Gastroenterology and Hepatology
Zip code 620-8505
Address 231 Atsunaka-cho, Fukuchiyama-city, Kyoto
TEL 0773-22-2101
Email na-iwai@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name Naoto
Middle name
Last name Iwai
Organization Fukuchiyama City Hospital
Division name Department of Gastroenterology and Hepatology
Zip code 620-8505
Address 231 Atsunaka-cho, Fukuchiyama-city, Kyoto
TEL 0773-22-2101
Homepage URL
Email na-iwai@koto.kpu-m.ac.jp

Sponsor
Institute Fukuchiyama City Hospital
Institute
Department

Funding Source
Organization Fukuchiyama City Hospital
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Fukuchiyama City Hospital
Address 231 Atsunaka-cho, Fukuchiyama-city, Kyoto
Tel 0773-22-2101
Email na-iwai@koto.kpu-m.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 市立福知山市民病院(京都府)

Other administrative information
Date of disclosure of the study information
2019 Year 04 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 Enrolling by invitation
Date of protocol fixation
2019 Year 03 Month 28 Day
Date of IRB
2019 Year 03 Month 27 Day
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2021 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
2019 Year 03 Month 28 Day
Last modified on
2020 Year 09 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041364

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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