UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015091 |
|---|---|
| Receipt number | 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 00:31:35 |
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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
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
ykataoka-nms@umin.org
Sponsor or person
Institute
Graduate School of Medicine, University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017329
