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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022525
Receipt No. R000024376
Scientific Title A study to assess the feasibility, safety and efficacy of cold snare polypectomy for multiple duodenal adenomas in patients with familial adenomatous polyposis (a single center, prospective phase I/II study)
Date of disclosure of the study information 2016/05/31
Last modified on 2021/07/08

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Basic information
Public title A study to assess the feasibility, safety and efficacy of cold snare polypectomy for multiple duodenal adenomas in patients with familial adenomatous polyposis (a single center, prospective phase I/II study)
Acronym Cold snare polypectomy for multiple duodenal adenomas in patients with familial adenomatous polyposis
Scientific Title A study to assess the feasibility, safety and efficacy of cold snare polypectomy for multiple duodenal adenomas in patients with familial adenomatous polyposis (a single center, prospective phase I/II study)
Scientific Title:Acronym Cold snare polypectomy for multiple duodenal adenomas in patients with familial adenomatous polyposis
Region
Japan

Condition
Condition Familial adenomatous polyposis (FAP), Multiple duodenal polyposis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the feasibility, safety and efficacy of cold snare polypectomy for multiple duodenal adenomas in patients with familial adenomatous polyposis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Phase I: Adverse event rate (during the 28 days after the intervention, >= CTCAE v4.0 Grade 3)

Phase II: Downstaged patient rate using Spigelman staging system (at follow-up endoscopy a year after the intervention)
Key secondary outcomes Phase I
(1) Arterial bleeding rate (during the procedure)
(2) Adverse event rate (during the 28 days after the intervention)
(3) Procedure time

Phase II:
(1) Spigelman score (stage) differences between pre-procedure and post-procedure (at follow-up endoscopy 2-3 months after the intervention and a year after the intervention)
(2) Arterial bleeding rate (during the procedure)
(3) Adverse event rate (during the 28 days after the intervention, >= CTCAE v4.0 Grade 3)
(4) Adverse event rate (during the 28 days after the intervention)
(5) Procedure time

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Cold snare polypectomy is performed for multiple duodenal adenomas, then the patients will be followed -up endoscopically and histological tissue examination of duodenal adenomas will be performed.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria (1) Spigelman stage of I-IV disease.
(2) Performance status (ECOG) of 0-2.
(3) Meeting all of the following criteria without blood transfusion in the past 14 days.
i) Hb: >=9.0 g/dl
ii) Plt: >=100000 /mm3
iii) AST, ALT: <=150 U/l
iv) Cre: <=2.0 mg/dl
v) PT%: >= 70 %
(4) Available to be observed more than a year after the intervention.
(5) Written informed consent.
Key exclusion criteria (1) Endoscopic diagnosis of duodenal invasive cancer.
(2) History of duodenectomy.
(3) History of radiation therapy to the upper abdominal region.
(4) Systemic administration (intravenously or orally) of corticosteroid.
(5) Systemic administration (intravenously or orally) of either one or more drugs of anticoagulant agent or antiplatelet agent which cannot be suspended according to the Japanese guideline about antithrombotic agent.
(6) Systemic administration of non-steroid anti-inflammatory drug which cannot be suspended through 7 days before to 28 days after the intervention.
(7) Pregnant or lactation woman.
(8) Diagnosis of psychiatric diseases.
(9) With active bacterial or fungus infection.
(10) History of myocardial infarction or unstable angina pectoris within 3 months.
(11) With uncontrollable hypertension.
(12) With severe respiratory disease requiring continuous oxygen therapy.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Yoji
Middle name
Last name Takeuchi
Organization Osaka International Cancer Institute
Division name Department of Gastrointestinal Oncology
Zip code 541-8567
Address 3-1-69, Otemae, Chuo-ku, Osaka, Japan
TEL 06-6945-1181
Email takeuti-yo@mc.pref.osaka.jp

Public contact
Name of contact person
1st name Yoji
Middle name
Last name Takeuchi
Organization Osaka International Cancer Institute
Division name Department of Gastrointestinal Oncology
Zip code 541-8567
Address 3-1-69, Otemae, Chuo-ku, Osaka, Japan
TEL 06-6945-1181
Homepage URL
Email yoji.endoscopy@oici.jp

Sponsor
Institute Osaka International Cancer Institute
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor No
Name of secondary funder(s)

IRB Contact (For public release)
Organization Osaka International Cancer Institute IRB
Address 3-1-69, Otemae, Chuo-ku, Osaka 541-8567, Japan
Tel 06-6945-1181
Email yamamototaka@opho.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 大阪国際がんセンター(大阪府)

Other administrative information
Date of disclosure of the study information
2016 Year 05 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 60
Results
Results date posted
Results Delayed
Delay expected
Results Delay Reason On going for publication
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 No longer recruiting
Date of protocol fixation
2016 Year 03 Month 31 Day
Date of IRB
2016 Year 03 Month 31 Day
Anticipated trial start date
2016 Year 06 Month 01 Day
Last follow-up date
2020 Year 05 Month 31 Day
Date of closure to data entry
2020 Year 07 Month 31 Day
Date trial data considered complete
2020 Year 09 Month 04 Day
Date analysis concluded
2020 Year 12 Month 31 Day

Other
Other related information Phase I study had finished and phase II study is ongoing now.

Management information
Registered date
2016 Year 05 Month 30 Day
Last modified on
2021 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024376

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2021/07/08 20210621十二指腸FAP(UMIN再固定用2) .xlsx


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