UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility of underwater endoscopic mucosal resection for superficial nonampullary duodenal tumors
Title of the study (Brief title)	Feasibility of UEMR for nonampullary duodenal tumors
Region	Japan

Condition
Condition	duodenal tumor
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the utility and safety of underwater endoscopic mucosal resection for superficial nonampullary duodenal tumors
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Pathological complete resection rate (completeness of resection on follow-up endoscopy)
Key secondary outcomes	Endoscopic complete resection rate, R0 resection rate, Procedure time, Total procedure time, Total amount of infusion water, Adverse events

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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:Nonampullary duodenal tumors that can be removed endoscopically 2:Adenoma or Intramucosal cancer
Key exclusion criteria	1:ampullary tumor 2:tumors that are difficult to remove endoscopically 3:invasive cancer 4:residual lesions after EMR 5:patients with FAP or Lynch syndrome 6:patients with hematological abnormality 7:patients with severe organ failure 8:patients who have been judged as in appropriate for this study
Target sample size	25

Research contact person
Name of lead principal investigator	Noriya Uedo
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Department of Gastrointestinal Oncology
Address	1-3-3, Higashinari-ku, Osaka 537-8511, Japan
TEL	+81-6-6972-1181
Email	uedou-no@mc.pref.osaka.jp

Public contact
Name of contact person	Yasushi Yamasaki
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Department of Gastrointestinal Oncology
Address	1-3-3, Higashinari-ku, Osaka 537-8511, Japan
TEL	+81-6-6972-1181
Homepage URL
Email	yasshifive@yahoo.co.jp

Sponsor
Institute	Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 08 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 10 Day
Anticipated trial start date	2015 Year 08 Month 19 Day
Last follow-up date	2016 Year 09 Month 12 Day
Date of closure to data entry	2016 Year 09 Month 12 Day
Date trial data considered complete	2016 Year 09 Month 12 Day
Date analysis concluded	2016 Year 09 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	A follow up EGD 3 month after duodenal UEMR should be performed.

Management information
Registered date	2015 Year 08 Month 18 Day
Last modified on	2016 Year 09 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021649