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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Nonampullary duodenal adenomatous lesion | |
Classification by specialty |
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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 | |
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Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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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 |
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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 | ||||||
araim-cib@umin.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 | |
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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 |
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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 | |
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Baseline Characteristics | |
Participant flow | |
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Outcome measures | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019531 |
Research Plan | |
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Research case data specifications | |
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Research case data | |
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