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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015091
Receipt No. R000017329
Scientific Title Randomized Controlled Trial to assess the efficacy of a shielding method that utilises polyglycolic acid(PGA) sheets and fibrin glue to prevent bleeding after endoscopic submucosal dissection (ESD) for gastric neoplasms
Date of disclosure of the study information 2014/09/09
Last modified on 2019/09/14

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Basic information
Public title Randomized Controlled Trial to assess the efficacy of a shielding method that utilises polyglycolic acid(PGA) sheets and fibrin glue to prevent bleeding after endoscopic submucosal dissection (ESD) for gastric neoplasms
Acronym PAGER BUSTER trial (Polyglycolic acid And fibrin Glue to ERadicate Bleeding Ulcer in the STomach Esd for Risked patients)
Scientific Title Randomized Controlled Trial to assess the efficacy of a shielding method that utilises polyglycolic acid(PGA) sheets and fibrin glue to prevent bleeding after endoscopic submucosal dissection (ESD) for gastric neoplasms
Scientific Title:Acronym PAGER BUSTER trial (Polyglycolic acid And fibrin Glue to ERadicate Bleeding Ulcer in the STomach Esd for Risked patients)
Region
Japan

Condition
Condition early gastric cancer/gastric adenoma
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy of a shielding method that utilises polyglycolic acid(PGA) sheets and fibrin glue to prevent bleeding after endoscopic submucosal dissection(ESD) for gastric neoplasms.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes post-ESD bleeding rate(from soon after ESD to 28 days after ESD)
Key secondary outcomes 1)late post-ESD bleeding rate(from meal commencement after ESD to 28 days after ESD)
2)blood transfusion rate associated with post-ESD bleeding
3)the rate of complications caused by PGA sheets or fibrin glue
4)risk factor for post-ESD bleeding
5)post-ESD bleeding rate in the patients whose resected specimen sizes are over 40mm
6)post-ESD bleeding rate in the cases where mucosal defects are shielding completely by PGA sheets
7)the rate of emergency endoscopy after ESD

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
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 NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 endoscopic tissue shielding method with PGA sheets and fibrin glue will be performed after gastric ESD.
Interventions/Control_2 endoscopic tissue shielding method with PGA sheets and fibrin glue will not be performed after gastric ESD.
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)Meet at least one of the following criteria of high risk bleeding after ESD.
a)resection size would exceed 40mm because tumor size is expected to be >= 20mm.
b)resection size would exceed 40mm because ulcer scar is inside the tumor.
c)resection size would exceed 40mm because multiple adjacent lesions have to be resected in an en block fashion.
d)taking oral antithrombotic drug.
2)Post-ESD ulcer scar is expected to be one lesion (irrespective of the number of tumors).
3)Preoperative pathological diagnosis of gastric cancer or adenoma is confirmed by endoscopic biopsy.
4)no evidence of metastasis on computed tomography.
5)Aged 20 years old or over.
6)PS (ECOG) of 0 to 2.
7)Meet all of the following criteria (without blood transfusion in the past 14 days).
a) Hb >=9g/dl
b) Plt >=100,000/mm3
c) AST,ALT <=100IU/l
d) Cre <=2.0mg/dl
8)Available to be observed for at least 28 days after ESD.
9)With written informed consent.
Key exclusion criteria 1)History of endoscopic treatment for upper GI lesion in the past 28 days.
2)With a scheduled endoscopic treatment for esophageal lesion or duodenal lesion concurrently.
3)With a scheduled endoscopic treatment for upper GI lesion in 28 days after gastric ESD.
4)with heparinization.
5)With an allergy to proton pomp inhibitor.
6)Pregnant or lactation woman.
7) History of myocardial infarction or unstable angina pectoris within 3 months.
8)With uncontrollable hypertension.
9)Patients whom investigators judge to be unsuitable for this trial.
Target sample size 140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuhiro Fujishiro
Organization Graduate School of Medicine, University of Tokyo
Division name Department of Endoscopy and Endoscopic Surgery
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3815-5411
Email mtfujish-kkr@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yosuke Kataoka
Organization Graduate School of Medicine, University of Tokyo
Division name Department of gastroenterology Laboratory No.108
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3815-5411
Homepage URL
Email ykataoka-nms@umin.org

Sponsor
Institute Graduate School of Medicine, University of Tokyo
Institute
Department

Funding Source
Organization Graduate School of Medicine, University of Tokyo
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor NTT Medical Center Tokyo, Takeda General Hospital, Sanraku Hospital, Tokatsu-Tsujinaka Hospital, Yokohama City University Medical Center
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 東京大学医学部附属病院(東京都)、NTT東日本関東病院(東京都)、武田総合病院(京都府)、公益社団法人東京都教職員互助会三楽病院(東京都)、東葛辻仲病院(千葉県)、横浜市立大学附属市民総合医療センター

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 09 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
2014 Year 08 Month 05 Day
Date of IRB
2014 Year 08 Month 05 Day
Anticipated trial start date
2014 Year 09 Month 15 Day
Last follow-up date
2016 Year 10 Month 11 Day
Date of closure to data entry
2016 Year 10 Month 11 Day
Date trial data considered complete
2016 Year 10 Month 20 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 09 Month 08 Day
Last modified on
2019 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017329

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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