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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pan-intestinal capsule endoscopy | Experimental | PillCam Crohn's capsule protocol |
|
| Conventional colonoscopy | Active Comparator | Same-day colonoscopy under propofol sedation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pan-intestinal capsule endoscopy | Diagnostic Test | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with at least one potentially bleeding lesion detected in small bowel and/or colon | Potentially bleeding lesions include tumors, angiectasias, erosions, ulcers, diverticula or active bleeding | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: number of participants with any procedure-related adverse events | Adverse events include capsule retention, bowel preparation-related (nausea, vomiting, dizziness, seizures, abdominal pain or bloating), bleeding, perforation or cardiopulmonary complications | 2 weeks |
| Patient's preference: number of participants preferring capsule endoscopy or colonoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of bowel preparation at capsule endoscopy (small bowel) | Use of validated Brotz scale (4-grade qualitative assessment as excellent, good, fair or poor bowel preparation) | 2 weeks |
| Quality of bowel preparation at capsule endoscopy (colon) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruno Rosa, MD | Gastroenterology Department, Hospital da Senhora da Oliveira - Guimarães, Portugal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastroenterology Department, Hospital da Senhora da Oliveira | Guimarães | 4835-044 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42323957 | Derived | Souto M, Goncalves J, Silva VM, Rosa B, Cotter J. Concordance Between Pan-Intestinal Capsule Endoscopy and Colonoscopy for the Detection and Characterization of Colonic Lesions: Post Hoc Analysis on the Impact of Colonic Transit Time. J Gastroenterol Hepatol. 2026 Jun 21. doi: 10.1111/jgh.70505. Online ahead of print. |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| D006471 | Gastrointestinal Hemorrhage |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D004724 | Endoscopy |
| ID | Term |
|---|---|
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
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Prospective, single-blinded, single center cohort study. All patients will undergo pan-intestinal capsule endoscopy followed by conventional colonoscopy with deep sedation in the same day, with no need for further bowel preparation.
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The capsule endoscopy reader will be independent from the physicians performing the conventional colonoscopies, and all investigators will be blinded to each other's findings and reports. Capsule endoscopy and colonoscopy findings will be compared and in case of disagreement it will be discussed until a consensus is reached, if necessary, with the intervention of an independent third reader, experienced in both techniques and not involved in the primary reading of any of the examinations.
|
|
Questionnaire regarding preference based on overall experience and perception of the strengths and limitations of each procedure |
| 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
| 2 weeks |
| Quality of bowel preparation at colonoscopy | 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) | 2 weeks |
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013514 | Surgical Procedures, Operative |