Does Endoscope Position Detecting Unit Facilitate a Complete Colonoscopy Examination (UPD-3)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Chinese University of Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Hon Sok Fei, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01434199
First received: June 20, 2011
Last updated: September 13, 2011
Last verified: September 2011
  Purpose

As the incidence of colorectal cancer (CRC) has been rapidly rising in Asian countries, more and more screening colonoscopies are now being performed for prevention or early detection of this fatal disease. Complete colonoscopy as indicated by caecal intubation is essential to make it a reliable screening tool for colorectal cancer or polyps. Cecal intubation rate is highly variable and dependent on individual experience. Colonic looping is the commonest cause of incomplete colonoscopy. Magnetic endoscope imaging (MEI) is a non-radiological imaging technique to provide real time, three-dimensional image and position of the colonoscope during the procedure. It may facilitate straightening of colonic loops and hence cecal intubation.

The investigators aim to evaluate the benefit of MEI in term of cecal intubation rate across endoscopists of all levels of experience by making use of the newly developed Endoscopy Position Detecting Unit (UPD-3)by Olympus Optical Co, Ltd, Japan.

The investigators propose to conduct a prospective randomized controlled trial to compare the caecal intubation rate of colonoscopy being performed with and without UPD-3 guidance. Colonoscopies performed by endoscopists with different level of experience will be randomized to UPD-3 guided group or conventional group (no UPD-3 guidance). Patient controlled sedation (PCS) containing propofol and alfentanil will be given to all patients. The investigators hypothesize that UPD-3 guided colonoscopy is associated with high caecal intubation rate (complete colonoscopy), shorter time to caecum, less patient pain and lower sedative medication requirement. A high caecal intubation rate facilitates a reliable colonoscopy screening. Decreased colonic looping and shorter time to caecum may reduce patient discomfort during the procedure. It may also facilitate learning and acquiring the skill of colonoscopy in trainees.


Condition Intervention Phase
Colorectal Neoplasms
Procedure: UPD guidance
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Does Endoscope Position Detecting Unit Facilitate Caecal Intubation? A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • caecal intubation rate [ Time Frame: 10minutes in average after starting the procedure ] [ Designated as safety issue: No ]
    Caeal intubation is the landmark for complete colonoscopy. Caecal intubation would be documented after each procedure. The caecal intubation rate with or without UPD guidance would be compared. The result would provide information whether the UPD device can faciliate complete colonoscopy.


Secondary Outcome Measures:
  • Caecal intubation time [ Time Frame: 10 minutes in average after starting the procedure ] [ Designated as safety issue: No ]
    Comparison of caecal intubaton time between UPD guided and non-UPD guided group would provide information on whether UPD device faciliate complete colonoscopy.


Estimated Enrollment: 870
Study Start Date: July 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: UPD guided group
Both the colonoscopist and assistant will be viewing the imager screen during the whole procedure.
Procedure: UPD guidance
A real time, three-dimensional image and position of the colonoscope would be provided to the endoscopist during the procedure.
Other Name: Magnetic endoscope imaging (MEI)
No Intervention: non-UPD guided group
Conventional colonoscopy would be done without image guidance.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18 years or above
  • American Society of Anaesthesiologist (ASA) grading I-III
  • Scheduled for elective colonoscopy

Exclusion Criteria:

  • Previous colonic resection
  • Refuse to consent to participate
  • History of allergy to propofol or alfentanil
  • Has a pacemaker in situ
  • Pregnant lady
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01434199

Contacts
Contact: Sophie SF Hon, MD 852-2632 1495 honsf@surgery.cuhk.edu.hk
Contact: James YW Lau, MD 852-2632 1441 laujyw@surgery.cuhk.edu.hk

Locations
China, Hong Kong
Alice Ho Miu Ling Nethersole Hospital Recruiting
Hong Kong, Hong Kong, China
Contact: Sophie SF Hon, MD    852-2632 1495    honsf@surgery.cuhk.edu.hk   
Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong, China
Contact: Sophie SF Hon, MD    852-2632 1495    honsf@surgery.cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Sophie SF Hon, MD Chinese University of Hong Kong
  More Information

Publications:
Responsible Party: Hon Sok Fei, Associate consultant, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01434199     History of Changes
Other Study ID Numbers: CRE-2011.125-T
Study First Received: June 20, 2011
Last Updated: September 13, 2011
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
magnetic endoscope imaging
colonoscopy
caecal intubation

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 23, 2014