UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017320 |
|---|---|
| Receipt number | R000019948 |
| Scientific Title | A randomized phase II study to assess the efficacy of acid blocker on prevention of hemorrhage and healing of ulcers after endoscopic submucosal dissection(ESD) for gastric neoplasms |
| Date of disclosure of the study information | 2015/04/30 |
| Last modified on | 2017/05/13 18:28:55 |
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Basic information
Public title
A randomized phase II study to assess the efficacy of acid blocker on prevention of hemorrhage and healing of ulcers after endoscopic submucosal dissection(ESD) for gastric neoplasms
Acronym
PCAB study
Scientific Title
A randomized phase II study to assess the efficacy of acid blocker on prevention of hemorrhage and healing of ulcers after endoscopic submucosal dissection(ESD) for gastric neoplasms
Scientific Title:Acronym
PCAB study
Region
| Japan |
Condition
Condition
early gastric cancer/gastric adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess efficacy and safety of vonoprazan on prevention of hemorrhage and healing of ulcers after endoscopic submucosal dissection (ESD) for gastric neoplasms.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Post-ESD bleeding rate (soon after ESD to 28 days after ESD)
Key secondary outcomes
1) Healing rate of ulcer at follow - up endoscopy (56 days after ESD +- 3 days)
2) Post-ESD bleeding rate according to tumor location, tumor size and ulcerative findings (soon after ESD to 28 days after ESD)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Vonoprazan administration
Interventions/Control_2
Lansoprazole administration
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) Clinical diagnosis of Stage IA gastric cancer or gastric adenoma, and suspicion for Stage IA gastric cancer or gastric adenoma.
2) Performance of endoscopic treatment for only one lesion.
3) 20 years old or older.
4) Performance status (ECOG) of 0 to 2.
5) Meeting all of the following criteria without blood transfusion in the past 14 days.
i) Hb: >=9g/dl
ii) Plt: >=100000/mm3
iii) AST, ALT: <=100U/l
iv) Cre: <=2.0mg/dl
v) PT%: >=70%
6) Available to be observed more than 28 days after ESD.
7) Written informed consent.
Key exclusion criteria
1) History of gastrectomy or reconstruction of gastric tube.
2) History of radiation therapy to the upper abdominal region.
3) Undifferentiated-type cancer
4) Schedule of endoscopic treatment for esophageal or duodenal lesion concurrently.
5) History of endoscopic treatment for upper GI lesion in the past 28 days.
6) Schedule of endoscopic treatment for upper GI lesion within 28 days after the gastric ESD.
7) Allergy to vonoprazan and lansoprazole.
8) Systemic administration (intravenously or orally) of either one or more drugs of corticosteroid, anticoagulant agent or antiplatelet agent.
9) Systemic administration of non-steroid anti-inflammatory drug which cannot be suspended through 7 days before to 28 days after gastric ESD.
10) Pregnant or lactation woman.
11) Diagnosis of psychiatric diseases.
12) With active bacterial or fungus infection.
13) History of myocardial infarction or unstable angina pectoris within 3 months.
14) With uncontrollable hypertension.
15) With severe respiratory disease requiring continuous oxygen therapy.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriya Uedo |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Gastrointestinal Oncology
Zip code
Address
1-3-3, Nakamichi, Higashinari-ku, Osaka, Japan
TEL
06-6972-1181
uedou-no@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuyuki Ito |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Research Center, Osaka Medical Center for Cancer and Cardiovascular Diseases
Zip code
Address
1-3-3, Nakamichi, Higashinari-ku, Osaka, Japan
TEL
06-6972-1181
Homepage URL
kbyori01@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
No
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
大阪府立成人病センター(大阪府)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 30 | 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
| 2015 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 29 | Day |
Last modified on
| 2017 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019948
