UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002544 |
|---|---|
| Receipt number | 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 18:57:32 |
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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
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
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003092
