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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017320
Receipt No. 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

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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
Email 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
Email kbyori01@mc.pref.osaka.jp

Sponsor
Institute Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019948

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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