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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002544
Receipt No. R000003092
Scientific Title Evaluation of clinical usefulness of proton pump inhibitor after endoscopic mucosal resection or endoscopic submucosal dissection for esophageal cancer: A multicenter prospective randomized controlled trial
Date of disclosure of the study information 2009/09/28
Last modified on 2013/04/08

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Basic information
Public title Evaluation of clinical usefulness of proton pump inhibitor after endoscopic mucosal resection or endoscopic submucosal dissection for esophageal cancer: A multicenter prospective randomized controlled trial
Acronym PPI after EMR/ESD for esophageal cancer
Scientific Title Evaluation of clinical usefulness of proton pump inhibitor after endoscopic mucosal resection or endoscopic submucosal dissection for esophageal cancer: A multicenter prospective randomized controlled trial
Scientific Title:Acronym PPI after EMR/ESD for esophageal cancer
Region
Japan

Condition
Condition early esophageal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess whether proton pump inhibitor (PPI) can relieve the gastroesophageal reflux disease (GERD) like symptoms after performed endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) for esophageal cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Rates of GERD symptom
Key secondary outcomes 1) Rates of scar formation at the 5 weeks after endoscopic treatment.
2) Rates of GERD symptom with seven terms according to acid-reflux-related symptoms in FSSG (Frequency Scale for the Symptoms of GERD).
3) Incidence of EMR or ESD associated symptoms of pain
4) Improvement rates of GERD symptoms in those who got started PPI because of GERD symptom in non-PPI medicated group.
5) Adverse events and side effects of PPI medication.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 PPI medicated group, in whom PPI is given after endoscopic esophageal mucosal resection or endoscopic submucosal dissection
Interventions/Control_2 non PPI medicated group
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 who will be performed endoscopic treatment for esophageal cancer.
2. Absolute or relative indication of endoscopic treatment within the therapy guidelines for esophageal cancer.
3. Patients who have no risk of esophageal stricture after endoscopic treatment, e.g, the lesion is less than 5 cm of the longitudinal length or smaller than 3/4 of the circumference.
4. Patients with no prior chemotherapy, radiotherapy and surgical treatment for esophageal cancer.
5. Total score of FSSG is equal or lower than seven before endoscopic treatment.
6. Patients without apparent gastroesophageal reflux disease in endoscopy.
7. Patients without medication of PPI and H2 receptor antagonist.
8. Patients without history of radiotherapy for neck, chest, and upper abdominal region.
9. ECOG-Performance Status is zero or one.
10. Adult patients aged upper 20 years old.
11. Patient who can answer FSSG and VAS about his certain symptom.
12. Patients with adequate liver and renal function.
Laboratory data obtained within 4 weeks of enrollment must be as follows;
AST(GOT)<100 IU/L, ALT(GPT)<100 IU/L
13. Patients must sign an informed consent.

Key exclusion criteria 1. Patients with active peptic ulcer in stomach or duodenum.
2. Patients with active concomitant cancers.
3. Patients requiring systemic steroids medication.
4. Patients with continuous systemic medication of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
5. Patients who cannot discontinue anticoagulant drug or antiplatelet drug before endoscopic treatment.
6. Patients with severe mental disease or psychotic manifestation.
7.Patients who have been judged as inappropriate for this study for any reasons by the concerning investigators.
Target sample size 220

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Manabu Muto
Organization Kyoto University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 54 Shogoin-kawaharacho, Sakyo-ku, Kyoto 606-8507, Japan
TEL 075-751-4592
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kimiko Hori
Organization Kyoto University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address
TEL 075-751-4319
Homepage URL
Email

Sponsor
Institute Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization Kyoto University Graduate School of Medicine
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 京都大学医学部附属病院(京都府)、国立がんセンター中央病院(東京都)、国立がんセンター東病院(千葉県)、静岡県立がんセンター(静岡県)、大阪府立成人病センター(大阪府)、石川県立中央病院(石川県)、北里大学病院(神奈川県)、北野病院(大阪府)、NTT東日本関東病院(東京都)、岡山大学病院(岡山県)、福岡大学筑紫病院(福岡県)、広島市立市民病院(広島県)、東京大学医学部付属病院(東京都)、三豊総合病院(愛媛県)、福島県立医大病院(福島県)、富山大学医学部付属病院(富山県)

Other administrative information
Date of disclosure of the study information
2009 Year 09 Month 28 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
2009 Year 09 Month 25 Day
Date of IRB
Anticipated trial start date
2010 Year 03 Month 01 Day
Last follow-up date
2013 Year 12 Month 31 Day
Date of closure to data entry
2013 Year 12 Month 31 Day
Date trial data considered complete
2013 Year 12 Month 31 Day
Date analysis concluded
2014 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2009 Year 09 Month 25 Day
Last modified on
2013 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003092

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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