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

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 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

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

Value
https://center6.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