PillCam Colon Capsule Endoscopy for Ulcerative Colitis

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. Identifier: NCT01467609
Recruitment Status : Completed
First Posted : November 8, 2011
Last Update Posted : November 8, 2011
Information provided by (Responsible Party):
Zhizheng Ge, Shanghai Jiao Tong University School of Medicine

Brief Summary:
Pillcam colon capsule (PCC) endoscopy is a novel strategy tool to inspect colon mucosa. The aim of the present study is to evaluate if PCC endoscopy is able to precisely investigate patients with ulcerative colitis and reach high consistency to conventional colonoscopy.

Condition or disease
Ulcerative Colitis

Detailed Description:
Symptomatic patients with confirmed ulcerative colitis (UC) were enrolled in this prospective single-center study. No sooner had patients gone through Pillcam colon capsule (PCC) endoscopy solution than they got conventional colonoscopy which is recognized as the "gold standard" examination technique. The extent of mucosal damage and inflammatory lesions during both modalities were recorded for comparison. In addition, the regimen of bowel preparation, completion rate, colonic cleanliness, compliance or adverse events were analyzed.

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PillCam Colon Capsule Endoscopy Versus Conventional Colonoscopy for the Detection of the Severity and Extent of Ulcerative Colitis
Study Start Date : July 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Evaluate the accuracy of PCC endoscopy in the survey of ulcerative colitis compared with conventional compared with conventional
    the severity of patients investigated by PCC endoscopy and conventional colonoscopy the extent of evolved lesions extent investigated by PCC endoscopy and conventional colonoscopy the safety of PCC endoscopy course (eg: adverse events during bowel preparation and the course; the completion rate)

Secondary Outcome Measures :
  1. the gastrointestinal transit time (transit time from ingestion to excretion), cecum arrival time (transit time from ingestion to the cecum), and colon residence time (transit time from the arrival in the cecum to excretion)
  2. clinical data such as age, gender,chief complaint
  3. the Mayo score of each case
  4. the quality of colonic preparation
    4 grades contain excellent, good, fair and poor

Biospecimen Retention:   Samples Without DNA
regular biopsy was taken during conventional colonoscopy according to the activity and position of ulcerative colitis involved.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
academic hospital endoscopist of digestive department

Inclusion Criteria:

  • Adult patients (aged 18-70)
  • Ulcerative Colitis history
  • Suffering from symptoms such as hematochezia, diarrhea or abdominal pain

Exclusion Criteria:

  • Patients with a high risk for capsule retention (such as intestinal diverticula, acute abdominal pain without regular defecation indicating intestinal obstruction or a history of abdominal operation or intestinal reconstructed operation),
  • Patients allergic to sodium phosphate or polyethylene glycol (PEG) solution,
  • Patients with a history of Crohn's disease
  • Patients with serious systematic diseases such as congestive heart failure, renal failure or severe liver disease.

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 identifier (NCT number): NCT01467609

Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Principal Investigator: zhi zheng Ge, MD. Ph.D Clinical Professor of Gastroenterology Department, Shanghai Renji Hospital; Director, Head of Digestive Endoscopy Department, Shanghai Renji Hospital

Responsible Party: Zhizheng Ge, Shanghai Institute of Digestive Disease,Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Jiao Tong University School of Medicine Identifier: NCT01467609     History of Changes
Other Study ID Numbers: rjyyxhk2319
First Posted: November 8, 2011    Key Record Dates
Last Update Posted: November 8, 2011
Last Verified: November 2011

Keywords provided by Zhizheng Ge, Shanghai Jiao Tong University School of Medicine:
Pillcam colon capsule endoscopy
conventional colonoscopy
ulcerative colitis
endoscopic manifestation

Additional relevant MeSH terms:
Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases