UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of clinical and pathological features, and endoscopic therapy of nonampullary duodenal adenoma/carcinoma
Acronym	Analysis of features and endoscopic therapy of duodenal adenoma/carcinoma
Scientific Title	Analysis of clinical and pathological features, and endoscopic therapy of nonampullary duodenal adenoma/carcinoma
Scientific Title:Acronym	Analysis of features and endoscopic therapy of duodenal adenoma/carcinoma
Region	Japan

Condition
Condition	Nonampullary duodenal adenoma/carcinoma
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To reveal clinical and pathological features, and appropriate method of endoscopic therapy of nonampullary duodenal adenoma/carcinoma, retrospectively
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Rate of en bloc resection of lesions according to the method of endoscopic therapy
Key secondary outcomes	Relationship between patients background such as age, sex and comorbid disease, and lesions information such as localization, morphological findings, size and pathological findings

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who underwent endoscopic resection for nonampullary duodenal lesions which were pathologically diagnosed as adenoma or carcinoma
Key exclusion criteria	Patients evaluated incompetent by doctors in attendance
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Makoto Middle name Last name Arai
Organization	Chiba University Hospital
Division name	Gastroenterology
Zip code	260-8670
Address	Department of Gastroenterology and Nephrology, Graduate School of Medicine, Chiba University (K1), 1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken, 260-8670, Japan
TEL	043-226-2083
Email	araim-cib@umin.ac.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Maruoka
Organization	Chiba University Hospital
Division name	Gastroenterology
Zip code	260-8670
Address	1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken, 260-8670, Japan
TEL	043-226-2083
Homepage URL
Email	maruoka-cib@umin.ac.jp

Sponsor
Institute	Chiba University
Institute
Department

Funding Source
Organization	Chiba University
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	Research Ethics Committee, Graduate School of Medicine, Chiba University
Address	1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken, Japan
Tel	043-226-2501
Email	igaku-rinri@office.chiba-u.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	千葉大学医学部附属病院（千葉県）

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 19 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://pubmed.ncbi.nlm.nih.gov/34284025/
Number of participants that the trial has enrolled	126
Results	Both UEMR and EMRC had a significantly higher R0 resection rate than EMR. UEMR had significantly lower multiple resection and postbleeding rates than EMR. Only 1 patient (2.1%) who underwent EMRC experienced intraoperative and postoperative perforation. EMR was involved in RX/1 and piecemeal resection. The recurrence rates of EMR, UEMR, and EMRC were 4.3%, 2.0%, and 6.3%, respectively.
Results date posted	2022 Year 01 Month 26 Day
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	2007 Year 01 Month 08 Day
Date of IRB	2015 Year 01 Month 26 Day
Anticipated trial start date	2015 Year 01 Month 26 Day
Last follow-up date	2024 Year 01 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Retrospective study

Management information
Registered date	2015 Year 03 Month 19 Day
Last modified on	2022 Year 01 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019557