UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009025
Receipt number R000010593
Scientific Title Randomized comparison study(III phase)between manual inflation of the room air and Carbon dioxide(Co2) automatic inflation for the colon distension procedure during FDG-PET/C colonograph and CTA simultaneous examination as a preoperative colon cancer.
Date of disclosure of the study information 2012/10/03
Last modified on 2012/10/02 19:48:25

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Basic information

Public title

Randomized comparison study(III phase)between manual inflation of the room air and Carbon dioxide(Co2) automatic inflation for the colon distension procedure during FDG-PET/C colonograph and CTA simultaneous examination as a preoperative colon cancer.

Acronym

Same as above.

Scientific Title

Randomized comparison study(III phase)between manual inflation of the room air and Carbon dioxide(Co2) automatic inflation for the colon distension procedure during FDG-PET/C colonograph and CTA simultaneous examination as a preoperative colon cancer.

Scientific Title:Acronym

Same as above.

Region

Japan


Condition

Condition

Colon cancer

Classification by specialty

Gastrointestinal surgery Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To find out an appropriate colon distension procedure during FDG-PET/C colonograph and CTA simultaneous examination(preoperative colon cancer multi-mode fusion examination) as a preoperative colon cancer, compare prospectively the image evaluation, patient comfortability, amount o9f radiation for the operater between manual air inflation and Carbon dioxide(Co2) automatic inflation.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

Colon CT imaging evaluation(intestine and lesion display ability) during preoperative colon cancer multi-mode
fusion examination .

Key secondary outcomes

The degree of patient discomfort (pain, a sense of distension)
Comparison of examination times
Radiation dose to the examining staff measured during examination
Estimated patient radiation dose


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Manual air insufflation

Interventions/Control_2

Automated carbon dioxide insufflation

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

81 years-old >

Gender

Female

Key inclusion criteria

1.Palliative operation for Colon primary carcinoma
2.Diagnosed colon cancer histologically by endoscopic biopsy from the colon primary carcinoma lesion.
3.The tumor location comprehensively judged using endoscopic exam and preoperative imaging exam( abdomen, pelvis exam) are ceca, ascending colon, hepatic flexure, colon transversem,
splenic fleure,colon descendens, colon signoideum, proctosigmoid, rectum.
4.Radically resectable under the laparoscopic colon resection.
5. Registration age is over 20y, less than 80y.
6.No anamnesis of intestine excision(including stomach, excluding appendectomy)
7.No anamnesis of chemotherapy a/o radiation therapy for treatment of malignancy like other cancer.
8. 0 or 1 of performance status(ECOG)
9. Functions other organotrophics.
10.Acquired Preoperative colon cancer multi-modal fusion exam consent.
11. Performed colon endoscopy exam at Osaka University Hospital just before the pre operative colon cancer multi-modal fusion exam.
12.Acquired patient consent to understand the purpose of this study and patient will to join this clinical study by having thoroughly explanation.

Key exclusion criteria

1.Without satisfaction of selection std.
2.Active duplication cancer(synchronia duplication cancer as well as metachronous duplication cancer within 5 years of nondisease period. However, Carcinoma in situ healed by local therapy or lesion cancer in mucosa are not included in the active duplication cancer.)
3.Complicated insanity or mental disorder and judged the difficulty to join this study.
4.Non-controlable Diabates(HbA1c>=8.0%)
5.Need dialysis chronicity renal failure.
6.Continuous constitutional dose of steroid(via peroral or pervenous) or require state of immunosuppressant.
7.Severe heart disease case.
8.Having Pulmonary pneumatosis, fibrosis of lung
9.Continuous ingestion of analgetic including NSAIDs.
10.Complaining bellyache, distension just before the preoperative colon cancer multi-modal fusion exam.
11. In case of stomatosyte produced in Large intestine, small intestine.
12.Difficulity of walk by oneself.
13.In case of sever colon stenosis is informed before the colon cancer preoperative multi-modal fusion exam and study representative doctor or sub representative doctor judged no possibility of inflation to colon intestine.
14. eGFR calculated from Age, sexuality and serum creatine is less than 30 ml/min/1.73m2
15.In case of Iodo anaphyraxis.
16.Sever Anamnesis of thyroiditis
17. Anamnesis of iodo contrast media side effect.
18.Recognized intestine hemorrhage.
19.The others,In case of the doctor incharge judged inappropriate to join this study.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Seiki Hamada

Organization

Jinsenkai MI Clinic

Division name

Radiology

Zip code


Address

1-12-13,Shoji,Toyonaka,Osaka 560-0004,Japan

TEL

06-6840-0100.322

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yasuo Iwamoto

Organization

Jinsenkai MI Clinic

Division name

Research Secretariat

Zip code


Address

1-12-13,Shoji,Toyonaka,Osaka 560-0004,Japan

TEL

06-6840-0100.311

Homepage URL

http://www.jinsen-pet.jp/

Email

iwamoto@jinsen-pet.jp


Sponsor or person

Institute

Jinsenkai MI Clinic

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Osaka University
gastroenterological surgery

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

医療法人仁泉会MIクリニック(大阪府)


Other administrative information

Date of disclosure of the study information

2012 Year 10 Month 03 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


Results


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

Preinitiation

Date of protocol fixation

2012 Year 09 Month 10 Day

Date of IRB


Anticipated trial start date

2012 Year 10 Month 05 Day

Last follow-up date

2013 Year 04 Month 30 Day

Date of closure to data entry

2013 Year 04 Month 30 Day

Date trial data considered complete

2013 Year 04 Month 30 Day

Date analysis concluded

2013 Year 05 Month 31 Day


Other

Other related information



Management information

Registered date

2012 Year 10 Month 02 Day

Last modified on

2012 Year 10 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010593


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name