UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022525 |
|---|---|
| Receipt number | 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 19:21:46 |
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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
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
yoji.endoscopy@oici.jp
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024376
