UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008169
Receipt number R000009619
Scientific Title Single center randomized control trial of ultra-slim colonoscope with passive bending and high force transmission (PCF-PQ260) versus conventionally used slim colonoscope for unsedated colonoscopy in inflammatory bowel disease (IBD) patients.
Date of disclosure of the study information 2012/06/14
Last modified on 2018/06/22 09:24:02

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Basic information

Public title

Single center randomized control trial of ultra-slim colonoscope with passive bending and high force transmission (PCF-PQ260) versus conventionally used slim colonoscope for unsedated colonoscopy in inflammatory bowel disease (IBD) patients.

Acronym

PCF-PQ260 study for IBD

Scientific Title

Single center randomized control trial of ultra-slim colonoscope with passive bending and high force transmission (PCF-PQ260) versus conventionally used slim colonoscope for unsedated colonoscopy in inflammatory bowel disease (IBD) patients.

Scientific Title:Acronym

PCF-PQ260 study for IBD

Region

Japan


Condition

Condition

Inflammatory Bowel Disease

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

PCF-PQ260 was developed in order to achieve the facilitation of intubation, and to reduce patient's pain. The aim of this single center randomized control study is to compare the efficacy of the PCF-PQ260 with that of a conventionally used slim colonoscope in unsedated IBD patients undergoing total colonoscopy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

I. Patients rating of procedural pain related to colonoscopy by visual analogue scale

Key secondary outcomes

II. The facilitation of intubation
II-1. Completeness of intubation to the cecum
II-2. Time required for intubation to the cecum
III. Procedural complications in colonoscopy


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration


Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

II.Intervened group: Patients who are randomly assigned to receive total colonoscopy with PCF-PQ260. Intervention is at the day when patients are examined by total colonoscopy.

Interventions/Control_2

II.Control group: Patients who are randomlyassigned to receive total colonoscopy with conventionally used slim colonoscope (PCF-Q260A).
Intervention is at the day when patients are examined by total colonoscopy.

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

18 years-old <=

Age-upper limit


 Not applicable

Gender

Male and Female

Key inclusion criteria

I.IBD patients undergoing an elective, diagnostic, or screening colonoscopy at Hyogo college of Medicine Hospital are prospectively included.
II.Patients who had a diagnosis of IBD before colonoscopy
III.Patient was able to provide written informed consent to total colonoscopy basically without sedation and being randomized to the new ultrathin flexible scope (PCF-PQ260) group or to the conventional scope (PCF-Q260A) group.
IV.Patients aged 18 or older.

Key exclusion criteria

I.Cases of the short bowel syndrome.
II.Cases that have obvious bleeding from intestine and possibility of perforation.
III.Cases of the megacolon or toxic megacolon.
IV.Cases that have severe stenosis or adhesion.
V.Cases that have severe inflammation and high risk for colonoscopy.
VI.Patients could not provide consent or when patients preferred to receive sedation/analgesia from the start.
VII.Patient had undergone prior partial colonic resection
VIII.Cases whose preparation was incomplete before colonoscopy

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shiro Nakamura, MD. Ph.D.

Organization

Hyogo College of Medicine

Division name

Dept.of Internal medicine, Lower gastroenterology

Zip code


Address

1-1 Mukogawa, Nishinomiya, Hyogo 663-8501

TEL

0798-45-6662

Email

shiro@hyo-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshio Ohda MD.Ph.D.

Organization

Hyogo College of Medicine

Division name

Dept.of Internal medicine, Lower gastroenterology

Zip code


Address

1-1 Mukogawa, Nishinomiya, Hyogo 663-8501

TEL

0798-45-6662

Homepage URL


Email

y-ohda@hyo-med.ac.jp


Sponsor or person

Institute

Hyogo College of Medicine, Dept. of Internal medicine, Lower gastroenterology

Institute

Department

Personal name



Funding Source

Organization

None

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


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

兵庫医科大学病院


Other administrative information

Date of disclosure of the study information

2012 Year 06 Month 14 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications

https://www.ecco-ibd.eu/publications/congress-abstract-s/item/

Number of participants that the trial has enrolled


Results

The UC patient demographic characteristics were similar between these two study arms(one arm n=42). There were no significant differences in the cecal intubation rate(97.6%)and time (4min)between the new type scope group and the conventional type scope group.
However,the VAS score was significantly lower in the new type scope group than the conventional type scope group.

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

Enrolling by invitation

Date of protocol fixation

2012 Year 04 Month 10 Day

Date of IRB


Anticipated trial start date

2012 Year 04 Month 01 Day

Last follow-up date

2014 Year 04 Month 01 Day

Date of closure to data entry

2014 Year 06 Month 01 Day

Date trial data considered complete

2014 Year 08 Month 01 Day

Date analysis concluded

2014 Year 10 Month 01 Day


Other

Other related information

1)The subjects of this study became 156 people(UC107, CD49)in total.
2)We added the inclusion and exclusion criteria of the patients.
3)We set the main outcome end-point of the evaluation only the painful degree of subjects. Because VAS and Face rating scale were things of the same contents, we decided to evaluate it only in VAS.
Also,we set time required for intubation to the cecum and completeness of
intubation to the cecum and procedural complications in colonoscopy as secondary outcome.


Management information

Registered date

2012 Year 06 Month 14 Day

Last modified on

2018 Year 06 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009619


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name