UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Noriya Uedo
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Department of Gastrointestinal Oncology
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	Kazuyuki Ito
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Research Center, Osaka Medical Center for Cancer and Cardiovascular Diseases
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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