UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015382 |
|---|---|
| Receipt number | R000017896 |
| Scientific Title | Evaluation of sodium carboxymethyl cellulose (SCMC) and hyaluronic acid (HA) as a local injection solution of endoscopic submucosal dissection for early gastric cancer;Randomized controlled trial |
| Date of disclosure of the study information | 2014/10/14 |
| Last modified on | 2020/11/28 16:50:12 |
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Basic information
Public title
Evaluation of sodium carboxymethyl cellulose (SCMC) and hyaluronic acid (HA) as a local injection solution of endoscopic submucosal dissection for early gastric cancer;Randomized controlled trial
Acronym
RCT of ESD with SCMC or HA
Scientific Title
Evaluation of sodium carboxymethyl cellulose (SCMC) and hyaluronic acid (HA) as a local injection solution of endoscopic submucosal dissection for early gastric cancer;Randomized controlled trial
Scientific Title:Acronym
RCT of ESD with SCMC or HA
Region
| Japan |
Condition
Condition
Early gastric cancer and gastric adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the safety and efficacy of SCMC-ESD as compared to the HA-ESD of early gastric cancer and adenoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
procedural time
Key secondary outcomes
1.The amount of local injection solution of HA or SCMC
2.Number of times of use of hemostatic forceps for stop bleeding
3.Status of ulcer healing
4.Bleeding rate
5.Incidence rate of adverse events related to ESD
6.En block resection rate
7.R0 resection rate
8.Blood test: WBC,CRP (next day)
9.Changes in body temperature
10.Evaluate of technically difficult (evaluated at 10 levels with a VAS score)
(10point: very easy, 1point: very difficult)
11.Change of local injection solution
12.Change of the operator
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Using SCMC as a for submucosal injection solution.
Interventions/Control_2
Using HA as a for submucosal injection solution.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patient who will be performed ESD for gastric cancer or gastric adenoma.
2. Gastric neoplasms with indication of ESD.
3. Patient has no history of allergy to SCMC or HA.
4. ECOG performance status is 0 or 1 or 2.
5. Patient must sign an informed consent.
Key exclusion criteria
1.Psychosis
2.Patient who have synchronous lesion
3. Patients who cannot consent to use SCMC.
4. Patient with AP, Respiratory failure, Chronic hepatitis, Renal failure requiring dialysis, simultaneous cancer, continuous systemic steroid medication.
5. Patients with allergy to SCMC and HA.
6.Patients temporary interruption of antiplatlet agents and anticoagulants is not possible.
7.Patient under heparin replacement.
8.Patient who have been judged as psychotic manifestation.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ohira |
| Middle name | |
| Last name | Hiromasa |
Organization
Fukushima Medical University School of Medicine
Division name
Department of Gastroenterology
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima, Japan
TEL
024-547-1202
h-ohira@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Nakamura |
| Middle name | |
| Last name | Jun |
Organization
Fukushima medical university
Division name
Endoscopy division
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima, Japan
TEL
024-547-1583
Homepage URL
junn7971@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University School of Medicine, Department of Gastroenterology.
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University School of Medicine, Department of Gastroenterology.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB
Address
1 Hikarigaoka, Fukushima, Japan
Tel
024-547-1825
junn7971@fmu.ac.jp
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
福島県立医科大学部附属病院（福島県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
60
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 | 09 | Month | 10 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 10 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 09 | Day |
Last modified on
| 2020 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017896
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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