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PillCam Colon Capsule Endoscopy for Ulcerative Colitis

Sponsor
Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT01467609
Collaborator
(none)
20
Enrollment
16
Duration (Months)

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    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 :
    Jul 1, 2009
    Actual Primary Completion Date :
    Jul 1, 2010
    Actual Study Completion Date :
    Nov 1, 2010

    Outcome Measures

    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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Shanghai Jiao Tong University School of Medicine

    Investigators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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
    ClinicalTrials.gov Identifier:
    NCT01467609
    Other Study ID Numbers:
    • rjyyxhk2319
    First Posted:
    Nov 8, 2011
    Last Update Posted:
    Nov 8, 2011
    Last Verified:
    Nov 1, 2011
    Keywords provided by Zhizheng Ge, Shanghai Institute of Digestive Disease，Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Jiao Tong University School of Medicine
    Pillcam colon capsule endoscopy
    conventional colonoscopy
    ulcerative colitis
    endoscopic manifestation
    colonoscopy
    Additional relevant MeSH terms:
    Colitis
    Colitis, Ulcerative
    Ulcer

    Study Results

    No Results Posted as of Nov 8, 2011