Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Colon Adenoma Detection Rate Using Two Distal Colonoscope Attachments

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02665741
Recruitment Status : Completed
First Posted : January 28, 2016
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
The goal of this study is to compare two FDA approved distal colonoscope attachment devices, in order to identify which device can increase adenoma detection rate the most without increasing procedure time or risk.

Condition or disease Intervention/treatment Phase
Colon Cancer Screening Colon Polyps Colon Adenomas Water Exchange Colonoscopy Device: Olympus transparent cap Device: Medivators Endocuff Device: Control Not Applicable

Detailed Description:

Although mortality from colon cancer is decreasing, it remains the second leading cause of cancer related death in the United States. There are multiple factors contributing to this decrease, such as increased awareness, improving screening techniques, etc.

Of the available modalities approved for colon cancer screening in the United States, colonoscopy is considered the gold standard. Colonoscopy has the advantage of being both diagnostic and therapeutic, allowing the removal of pre-cancerous polyps, before the polyps can transform into cancer. Colonic polyps can occur at any location from the rectum to the cecum. Colonoscopy has been shown to be more effective in decreasing incidence of cancer in the left colon but remains limited in the detection of right sided polyps /lesions 2. This difference based on location is thought to be due to several reasons. Typically the right side of the colon is less clean than the left side during colonoscopy, thereby impairing visualization of polyps. This problem has been overcome by incorporating a "split bowel preparation", which has not become standard of care. However, the problem of not being able to visualize polyps behind folds seen in the colon persists despite improvements in the quality of cleansing of the colon. Various endoscopic technologies have been introduced with the goal of assisting with the manipulation of such colonic folds, and thereby reducing chances of missing polyps behind fold. Two such colonoscope assisted devices including the distal transparent cap and the Endocuff endoscopic overtube.

The Endocuff overtube is a small device with flexible arms arranged in 2 rows. Each row has 8 short, soft arms projecting away from the device. These arms are used to peel back the colonic folds without causing physical damage to enable visualization behind colonic folds. The use of Endocuff overtube has shown promising results in terms of cecal intubation rate and time as well as adenoma detection rates 3.

The transparent cap attachment is a clear plastic device that fits at the end of the colonoscope and extends a short distance past the tip of the colonoscope. It aids in the manipulation of folds and in maintaining a suitable distance from the mucosa, with the goal of improving visualization. Although some studies comparing cap fitted colonoscopy to standard (non- attachment) colonoscopies have shown improved adenoma detection 4, others have shown no significant benefit 5.

Although, these devices have been compared with conventional colonoscopies (i.e without any distal attachment), to the investigator's knowledge, there are currently no studies that have compared these two distal colonoscope attachment devices head-to-head, and none has specifically evaluated effects on detection of right sided adenomas. Also, here at UCDavis, these devices are being used specifically in diagnostic colonoscopies for removal of large polyps and the choice of which specific device is used dependends on level of comfort of the advanced endoscopist. The endoscopists participating in the investigators' study do not currently use these devices as part of their routine colonoscopies, thus it is important to provide head to head comparison of these devices to help guide management practice.

Therefore, the investigators' goal is to compare the Endocuff overtube assisted, transparent cap fitted, and non-cap fitted ( standard) colonoscopy in patients presenting to UC Davis Medical Center for screening colonoscopies.

In addition, 2 of the 3 investigators will employ the water exchange method during for all arms of the trial, while the other investigator will employ the conventional air method of colonoscopy.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Comparison of Colon Adenoma Detection Rate Using Two Distal Colonoscope Attachments
Study Start Date : January 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Arm Intervention/treatment
Control
No distal colonoscope attachment will be used in this arm
Device: Control
No distal colonoscope attachments

Experimental: Olympus transparent cap
The Olympus transparent cap will be attached to the distal end of colonoscope prior to starting the procedure
Device: Olympus transparent cap
distal colonscope attachment

Experimental: Medivators Endocuff
The Medivators Endocuff will be attached to the distal end of colonoscope prior to starting the procedure
Device: Medivators Endocuff
distal colonscope attachment




Primary Outcome Measures :
  1. Adenoma detection rate [ Time Frame: 1 year ]
    The investigators will compare adenoma detection rate at completion of study across the 4 arms


Secondary Outcome Measures :
  1. Proximal adenoma detection rate [ Time Frame: 1 year ]
    The investigators will compare proximal adenoma detection rate at completion of study across the 4 arms

  2. Polyp detection rate [ Time Frame: 1 year ]
    The investigators will compare polyp detection rate at completion of study across the 4 arms

  3. Cecal intubation rate [ Time Frame: 1 year ]
    The investigators will compare cecal intubation rate at completion of study across the 4 arms

  4. Withdrawal time [ Time Frame: 1 year ]
    The investigators will compare colonoscopy withdrawal time rate at completion of study across the 4 arms

  5. Major complications (perforation, bleeding requiring transfusion) [ Time Frame: 1 year ]
    The investigators will compare major complications at completion of study across the 4 arms



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All patients >/= 50 years of age, presenting for a screening or surveillance colonoscopy at UC Davis Endoscopy Suites

Exclusion Criteria:

i) Age less than 50 (ii) Prior history of colon cancer (iii) Patients with inflammatory bowel disease (iv) Patients suspected to have colon cancer based on non invasive tests such as stool tests for hemoglobin or DNA, or imaging finding suggestive of colon cancer (CT or barium enema).

(v) Patients undergoing colonoscopy for evaluation of symptoms such as abdominal pain, rectal bleeding, diarrhea, constipation, etc, or patient with iron deficiency anemia suspected to be due to ongoing bleeding inside the colon (vi) Patients with family history of colon cancer in 1st degree relative below the age of 60 (vii) Patients with family history of hereditary polyposis syndromes such as Lynch syndrome, familial adenomatous polyposis etc, which are associated with an increased risk of colon cancer (viii) Patients unable to consent (ix) Pregnant patients (x) Incarcerated patients (xi) Non-English speakers


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02665741


Locations
Layout table for location information
United States, California
University of California, Davis
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis

Publications:
Layout table for additonal information
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02665741     History of Changes
Other Study ID Numbers: 797109
First Posted: January 28, 2016    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by University of California, Davis:
distal colonoscope attachments, colon cancer screening, screening colonoscopy, adenoma detection

Additional relevant MeSH terms:
Layout table for MeSH terms
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenoma
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases