Gastrointestinal Diseases Clinical Trial
Official title:
Assessing Depth of Small Bowel Insertion at Push Enteroscopy by Using Capsule Endoscopy to Determine Best Diagnostic Approach for Patients With Obscure Gastrointestinal Bleeding
Verified date | June 2023 |
Source | Unity Health Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Bleeding from the gastrointestinal tract can originate from the small bowel. Typically, upper and lower endoscopies are unable to identify the site of bleeding and patients need to undergo special endoscopies with longer cameras to examine the small bowel and find the bleeding site. One of the most commonly used scopes to investigate the first part of the small intestinal is called "push enteroscopy". This is an upper endoscopy that uses a pediatric colonoscope, which is longer. To date, it is unknown what percentage of small bowel can be observed with this technique. Hence, this study aimed to determine the extent of small bowel examined by push enteroscopy. Consecutive patients with suspected bleeding from the small intestine will undergo a push enteroscopy and the depth of the examination will be marked with metallic clips. Subsequently, patients will have a capsule endoscopy, which is a little camera that will take multiple pictures of the whole small intestine. The percentage of small bowel that the push enteroscopy examined will be determined by the percentage of small bowel corresponding to the location of the clips visualized on capsule endoscopy.
Status | Active, not recruiting |
Enrollment | 59 |
Est. completion date | December 1, 2023 |
Est. primary completion date | November 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients with overt signs of GI bleeding (OGIB) (hematochezia or melena with an associated drop in hemoglobin) or occult signs of GI bleeding in the form of persistent or recurrent iron deficiency anemia and had undergone esophagogastroduodenoscopy (EGD) and colonoscopy that were negative for a source of bleeding. Exclusion Criteria: - Significant cardiopulmonary disease, an implanted electromedical device, pregnancy, previous gastrectomy, extensive Crohn's disease with suspicion for stricturing or fistulizing small bowel disease |
Country | Name | City | State |
---|---|---|---|
Canada | St. Michael's Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Unity Health Toronto |
Canada,
Barkin JS, Lewis BS, Reiner DK, Waye JD, Goldberg RI, Phillips RS. Diagnostic and therapeutic jejunoscopy with a new, longer enteroscope. Gastrointest Endosc. 1992 Jan-Feb;38(1):55-8. doi: 10.1016/s0016-5107(92)70333-2. No abstract available. — View Citation
Cortegoso Valdivia P, Skonieczna-Zydecka K, Pennazio M, Rondonotti E, Marlicz W, Toth E, Koulaouzidis A. Capsule endoscopy transit-related indicators in choosing the insertion route for double-balloon enteroscopy: a systematic review. Endosc Int Open. 2021 Feb;9(2):E163-E170. doi: 10.1055/a-1319-1452. Epub 2021 Jan 25. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of small bowel examination | Proportion of the small intestine that can be evaluated by using the PE technique. | through study completion, an average of 3 years | |
Secondary | Diagnostic yield of CE and PE in identifying the cause of obscure gastrointestinal bleeding, comparison of the detection rates between the two modalities and adverse events related to these procedures | through study completion, an average of 3 years |
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