PillCam Colon Capsule Endoscopy for Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

PillCam Colon Capsule Endoscopy Versus Conventional Colonoscopy for the Detection of the Severity and Extent of Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01467609
• Other study ID #: rjyyxhk2319
• Status: Completed
• Phase: N/A
• First received: October 20, 2011
• Last updated: November 4, 2011
• Start date: July 2009
• Est. completion date: November 2010

Study information

• Verified date: November 2011
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	clinical data such as age, gender,chief complaint
Secondary	the Mayo score of each case
Secondary	the quality of colonic preparation	4 grades contain excellent, good, fair and poor