UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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	Shiro Nakamura, MD. Ph.D.
Organization	Hyogo College of Medicine
Division name	Dept.of Internal medicine, Lower gastroenterology
Address	1-1 Mukogawa, Nishinomiya, Hyogo 663-8501
TEL	0798-45-6662
Email	shiro@hyo-med.ac.jp

Public contact
Name of contact person	Yoshio Ohda MD.Ph.D.
Organization	Hyogo College of Medicine
Division name	Dept.of Internal medicine, Lower gastroenterology
Address	1-1 Mukogawa, Nishinomiya, Hyogo 663-8501
TEL	0798-45-6662
Homepage URL
Email	y-ohda@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine, Dept. of Internal medicine, Lower gastroenterology
Institute
Department

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2012 Year 04 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results	https://www.ecco-ibd.eu/publications/congress-abstract-s/item/
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009619