UMIN-CTR Clinical Trial

Basic information
Public title	Technical feasibility and safety of Underwater endoscopic mucosal resection versus Cold snare polypectomy for superficial non-ampullary Duodenal epithelial tumor; A randomized control trials.
Acronym	DUC study
Scientific Title	Technical feasibility and safety of Underwater endoscopic mucosal resection versus Cold snare polypectomy for superficial non-ampullary Duodenal epithelial tumor; A randomized control trials.
Scientific Title:Acronym	DUC study
Region	Japan

Condition
Condition	Superficial non-ampullary duodenal epithelial tumor
Classification by specialty	Gastroenterology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To conduct a comparative study on the efficacy and safety of underwater endoscopic mucosal resection (UEMR) and cold snare polypectomy (CSP) for duodenal non-papillary epithelial tumors of 12 mm or less.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Primary endpoint is the percentage of complete pathological resection (negative horizontal and vertical resection margins and proportion of resected specimens with submucosa).
Key secondary outcomes	Secondary endpoints include en bloc resection rate, R0 resection rate, resected lesion diameter, treatment time, pathological evaluation of resected lesions (resection thickness, resection distance, presence or absence of mucosal muscle plate, presence or absence of submucosal layer), accidental occurrence (bleeding, perforation, etc.) And the rate of remnants and recurrences after 6 months.

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Regarding UEMR, the lumen is first evacuated and then saline is injected. Thereafter, the snare is placed on the lesion and strangled. After confirming that there is no tumor left on the margin, the lesion is resected. After resection, confirm that there are no complications such as bleeding or perforation and no residual lesions. Finally, clipping is performed on the resected part.
Interventions/Control_2	As for CSP, when the lumen is filled with air (carbon dioxide) and the lesion is visually recognized, a snare is placed on the lesion and strangulation is performed. After confirming that there is no tumor left on the margin, resection is performed using a snare wire for CSP without applying power. In principle, clipping after resection is not performed, and if spurting bleeding is recognized, hemostatic closure is performed at the discretion of the attending physician.
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	Patients aged 20 years or older who are scheduled to undergo endoscopic treatment for lesions diagnosed as low-grade duodenal tumors of 12 mm or less in our department. If there are multiple lesions, only the largest lesion, which is 12 mm or less, shall be regarded as accurate and assigned. Regarding postoperative complications, if only the same lesion is involved and bleeding or perforation occurs in other lesions of multiple lesions, it is regarded as different.
Key exclusion criteria	1) Patients with multiple duodenal tumors associated with Familiar adenomatous polyposis and hereditary non-polyposis colorectal cancer 2) Patients who strongly suspect cancer / high grade adenoma in preoperative examination and biopsy 3) Patients who have undergone surgery for the upper gastrointestinal tract 4) Patients with blood coagulation dysfunction, patients who cannot manage anticoagulant / antiplatelet agents according to the guidelines for medical treatment of gastrointestinal endoscopy 5) Severe organ failure case 6) Cases determined by the attending physician to be inappropriate for registration
Target sample size	130

Research contact person
Name of lead principal investigator	1st name Motohiko Middle name Last name Kato
Organization	Keio University, school of medicine
Division name	Gastroenterology
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	0333531211
Email	motohikokato@keio.jp

Public contact
Name of contact person	1st name Yoshiyuki Middle name Last name Kiguchi
Organization	Keio University, school of medicine
Division name	Cancer center, division of research and development for minimal invasive treatment
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	0333531211
Homepage URL
Email	kiguchiyoshiyuki@keio.jp

Sponsor
Institute	Keio University
Institute
Department

Funding Source
Organization	Self funding
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	Keio University, school of medicine
Address	35, Shinanomachi, Shinjyuku-ku, Tokyo, Japan
Tel	0333531211
Email	kiguchiyoshiyuki@keio.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

Other administrative information
Date of disclosure of the study information	2020 Year 01 Month 06 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	Open public recruiting
Date of protocol fixation	2020 Year 01 Month 06 Day
Date of IRB	2019 Year 11 Month 26 Day
Anticipated trial start date	2020 Year 01 Month 06 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 01 Month 06 Day
Last modified on	2020 Year 07 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044419