UMIN-CTR Clinical Trial

Basic information
Public title	Prospective intervention trial to evaluate the effectiveness of PPI for healing of ulcer after ESD
Acronym	Prospective intervention trial to evaluate the effectiveness of PPI for healing of ulcer after ESD
Scientific Title	Prospective intervention trial to evaluate the effectiveness of PPI for healing of ulcer after ESD
Scientific Title:Acronym	Prospective intervention trial to evaluate the effectiveness of PPI for healing of ulcer after ESD
Region	Japan

Condition
Condition	superficial esophageal cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	In endoscopic ulcers after gastric ESD, the effectiveness of proton pump inhibitor (PPI) on ulcer healing and prevention of postoperative bleeding has been reported, but after esophageal ESD there is no hint of adequate evidence PPI is used in the current situation. In this study, we will prospectively investigate the effectiveness of PPI for ulcer healing after esophageal cancer ESD.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Presence or absence of healing of ulcer 4 weeks after esophagus ESD.
Key secondary outcomes	Presence or absence of healing of ulcer 8 weeks after esophagus ESD.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Oral PPI for 8 weeks
Interventions/Control_2	Do not take PPI for 8 weeks
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 Patients with lesions whose resected area is expected to be less than three-fourths round 2 With regard to participation in this study, patients who gained document consent by their own voluntary intention
Key exclusion criteria	1 Patients with lesions whose resection range is predicted to be more than three-fourths round 2 Patients who can not receive endoscopic examination for evaluating ulcer healing 3 Patients taking steroids before treatment 4 Patients who have taken PPI from before treatment and can not be discontinued
Target sample size	160

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Shinwa Tanaka
Organization	Kobe University Graduate School of Medicine
Division name	Department of Gastroenterology
Zip code
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe,650-0017, Japan
TEL	078-382-5774
Email	tanakas@med.kobe-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Koki Matsuoka
Organization	Kobe University Graduate School of Medicine
Division name	Department of Endoscopy
Zip code
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe,650-0017, Japan
TEL	078-382-5774
Homepage URL
Email	mkouki@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University
Institute
Department

Funding Source
Organization	Kobe 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

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 10 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	Terminated
Date of protocol fixation	2017 Year 10 Month 31 Day
Date of IRB	2018 Year 04 Month 01 Day
Anticipated trial start date	2018 Year 01 Month 01 Day
Last follow-up date	2018 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 11 Month 10 Day
Last modified on	2019 Year 05 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033909