PillCam Colon Capsule Endoscopy for Ulcerative Colitis

NCT01467609 | Completed

• 1 other identifier: rjyyxhk2319
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ulcerative Colitis

Keywords

Pillcam colon capsule endoscopy; conventional colonoscopy; ulcerative colitis; endoscopic manifestation; colonoscopy

Outcome Measures

Primary Outcomes (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 Outcomes (4)

• 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)

• clinical data such as age, gender,chief complaint

• the Mayo score of each case

• the quality of colonic preparation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

academic hospital endoscopist of digestive department

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

regular biopsy was taken during conventional colonoscopy according to the activity and position of ulcerative colitis involved.

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• zhi zheng Ge, MD. Ph.D

  Clinical Professor of Gastroenterology Department, Shanghai Renji Hospital; Director, Head of Digestive Endoscopy Department, Shanghai Renji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Shanghai Institute of Digestive Disease，Renji Hospital, Shanghai Jiao Tong University School of Medicine

Study Record Dates

• First Submitted: October 20, 2011
• First Posted: November 8, 2011
• Study Start: July 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: November 1, 2010
• Last Updated: November 8, 2011

Record last verified: 2011-11