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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016829
Receipt No. R000019531
Scientific Title Efficacy and safety of cold polypectomy for nonampullary duodenal adenomatous lesion
Date of disclosure of the study information 2015/03/17
Last modified on 2017/07/02

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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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