Gastroenterology Department, Hospital da Senhora da Oliveira
Guimarães, 4835-044, Portugal
NCT Number: NCT04782986
The authors hypothesize that in patients with iron deficiency anemia or gastrointestinal bleeding, pan-intestinal capsule endoscopy is a safe and well tolerated procedure that may improve diagnostic yield comparatively to the current standard invasive colonoscopy.
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Notify Me8 year–100 year
All sexes
Interventional
Not applicable
Guimarães, 4835-044, Portugal
Patients presenting with iron deficiency anemia (IDA) or overt GI bleeding are often submitted to conventional upper GI endoscopy and colonoscopy, followed by small bowel capsule endoscopy if diagnosis remains elusive. Recently, however, the possibility of performing pan-intestinal endoscopy using a video capsule that evaluates both the small bowel and the colon in a single non-invasive examination, opens new perspectives for the management of those conditions, particularly when the initial upper GI endoscopy has been non-diagnostic. The authors hypothesize that performing early pan-intestinal capsule endoscopy strategy may allow, in a safe and well tolerated manner, to identify which patients would benefit of further interventions, such as colonoscopy or invasive enteroscopy, guided by findings pre-identified at capsule examination. The study aims to evaluate whether pan-intestinal capsule endoscopy is superior to the current standard strategy of conventional colonoscopy after non-diagnostic upper endoscopy in patients with IDA or overt GI bleeding, regarding diagnostic yield, safety and tolerability.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients with iron deficiency anemia or overt GI bleeding with non-diagnostic upper GI endoscopy will be submitted to same-day pan-intestinal capsule endoscopy using PillCam Crohn's Capsule (Medtronic) followed by conventional colonoscopy under propofol sedation
Other names: Conventional colonoscopy
Time frame: 2 weeks
Potentially bleeding lesions include tumors, angiectasias, erosions, ulcers, diverticula or active bleeding
Time frame: 2 weeks
Adverse events include capsule retention, bowel preparation-related (nausea, vomiting, dizziness, seizures, abdominal pain or bloating), bleeding, perforation or cardiopulmonary complications
Time frame: 2 weeks
Questionnaire regarding preference based on overall experience and perception of the strengths and limitations of each procedure
Time frame: 2 weeks
Use of validated Brotz scale (4-grade qualitative assessment as excellent, good, fair or poor bowel preparation)
Time frame: 2 weeks
Use of validated scale CC-CLEAR (Colon Capsule CLEansing Assessment and Report) - quantitative scale: adequate bowel preparation if overall score >= 6 points, and >= 2 points in each bowel segment (right, transverse, and left colon). Overall 0-5 points inadequate; 6-7 points good; 8-9 points excellent bowel preparation
Time frame: 2 weeks
Use of validated Boston Bowel Preparation Scale: quantitative scale 0-9 points - adequate bowel preparation if overall score >= 6 points, and >= 2 points in each bowel segment (right, transverse, and left colon)
Unidade Local de Saúde do Alto Ave, EPE
Other
Pan-intestinal Capsule Endoscopy Versus Conventional Colonoscopy in Iron Deficiency Anemia or Overt GI Bleeding: a Prospective Cohort Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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