UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and safety of cold polypectomy for nonampullary duodenal adenomatous lesion
Acronym	Cold polypectomy for nonampullary duodenal adenoma
Scientific Title	Efficacy and safety of cold polypectomy for nonampullary duodenal adenomatous lesion
Scientific Title:Acronym	Cold polypectomy for nonampullary duodenal adenoma
Region	Japan

Condition
Condition	Nonampullary duodenal adenomatous lesion
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To reveal the efficacy and safety of endoscopic cold polypectomy for nonampullary duodenal adenomatous lesion
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The rate of pathological local recurrence at 3 months after endoscopic cold polypectomy for nonampullary duodenal adenomatous lesion by biopsy from the scar after polypectomy
Key secondary outcomes	The rate of morphological local recurrence at 3 months after endoscopic cold polypectomy for nonampullary duodenal adenomatous lesion by biopsy from the scar after polypectomy and relationship between these and patients background or lesion information

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 cold polypectomy for nonampullary duodenal adenomatous lesions
Key exclusion criteria	Patients evaluated incompetent by doctors in attendance
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Makoto Arai
Organization	Chiba University Hospital
Division name	Gastroenterology
Zip code
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 Middle name Last name Daisuke Maruoka
Organization	Chiba University Hospital
Division name	Gastroenterology
Zip code
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
Address
Tel
Email

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 17 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://www.ncbi.nlm.nih.gov/pubmed/28493238
Number of participants that the trial has enrolled
Results	Overall, 39 lesions in 30 patients were removed via cold polypectomy (CFP, 9 lesions in 8 patients; CSP, 30 lesions in 22 patients). Seven of 9 (77.8%) and 29 of 30 (96.7%) lesions were removed en bloc via CFP and CSP, respectively. Pathologically, 34 of the 39 lesions (87.2%) were confirmed as adenomas, and their mean size was 3.9+-1.2mm (range 2-6mm). Of the 34 adenomas, 20 (58.8%) were R0 resection lesions, of which 3 of 9 (33.3%) and 17 of 25 (68.0%) had undergone CFP and CSP, respectively. No delayed bleeding or intraprocedural/delayed perforation was observed. All 30 patients with the 34 pathologically confirmed adenomas underwent upper gastrointestinal endoscopy 3 months after cold polypectomy, and no morphological or pathological recurrence was identified.
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	2015 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date	2015 Year 03 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Patients who had undergone cold polypectomy for nonampullary duodenal adenomatous lesion underwent periodic endoscopy and biopsied scar after cold polypectomy at 3 months after ESD.

Management information
Registered date	2015 Year 03 Month 17 Day
Last modified on	2017 Year 07 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019531

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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