Clinical trial NCT01467609: PillCam Colon Capsule Endoscopy for Ulcerative Colitis
Official title: PillCam Colon Capsule Endoscopy Versus Conventional Colonoscopy for the Detection of the Severity and Extent of Ulcerative Colitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Keywords: Pillcam colon capsule endoscopy
conventional colonoscopy
ulcerative colitis
endoscopic manifestation
colonoscopy
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2011-11-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: academic hospital endoscopist of digestive department

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.

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 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.

Primary outcomes:
measure: Evaluate the accuracy of PCC endoscopy in the survey of ulcerative colitis compared with conventional compared with conventional
Secondary outcomes:
measure: 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)
measure: clinical data such as age, gender,chief complaint
measure: the Mayo score of each case
measure: the quality of colonic preparation
Other outcomes:
Locations:
Study officials:
affiliation: Clinical Professor of Gastroenterology Department, Shanghai Renji Hospital; Director, Head of Digestive Endoscopy Department, Shanghai Renji Hospital
name: zhi zheng Ge, MD. Ph.D
role: PRINCIPAL_INVESTIGATOR
References: