UMIN-CTR Clinical Trial

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
Email	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
Email	junn7971@fmu.ac.jp

Sponsor
Institute	Fukushima Medical University School of Medicine, Department of Gastroenterology.
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017896