PillCam Colon Capsule Endoscopy for Ulcerative Colitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zhizheng Ge, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01467609
First received: October 20, 2011
Last updated: November 4, 2011
Last verified: November 2011
  Purpose

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
Ulcerative Colitis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • Evaluate the accuracy of PCC endoscopy in the survey of ulcerative colitis compared with conventional compared with conventional [ Designated as safety issue: No ]
    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:
  • 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) [ Designated as safety issue: Yes ]
  • clinical data such as age, gender,chief complaint
  • the Mayo score of each case
  • 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.


Enrollment: 20
Study Start Date: July 2009
Study Completion Date: November 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

academic hospital endoscopist of digestive department

Criteria

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
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: NCT01467609

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
  More Information

No publications 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     History of Changes
Other Study ID Numbers: rjyyxhk2319
Study First Received: October 20, 2011
Last Updated: November 4, 2011
Health Authority: China: Ethics Committee
China: Ministry of Health

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

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

ClinicalTrials.gov processed this record on September 16, 2014