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To evaluate the incidence and etiology of small bowel or large bowel bleeding in patients presenting with melena.
Although tarry stool is a common feature of peptic ulcer bleeding, it can also be a manifestation of lower gastrointestinal (GI) bleeding. Examples include colonic cancer, small bowel tumors, and small or large bowel ulcers induced by aspirin or painkillers (NSAIDs). However, clinicians are often misled by the finding of peptic ulcers as the source of GI bleeding. It is not uncommon to detect peptic ulcers incidentally but the source of bleeding is actually in the lower GI tract (e.g. NSAID- or aspirin-induced small or large bowel bleeding ulcers, small bowel tumors, or colorectal cancer). Delay in diagnosis of lower GI bleeding often leads to serious consequences.
The preferred investigations for lower GI bleeding are colonoscopy plus video capsule endoscopy. Colonoscopy has been the gold standard for the diagnosis of colonic bleeding. The risk of colonoscopy-induced complications such as bleeding or perforation is less than 1 in 3500. Video capsule endoscopy is a non-invasive, safe and accurate technology that has been approved by the FDA for investigation of small bowel diseases. The video capsule is an 11x 26mm capsule that encases a digital camera, light-emitting diodes, batteries, and a transmitter. The patient needs to swallow the video capsule after an overnight fast and wear a recording device for eight hours. Images are taken twice-per-second and transmitted to the recording device. Oral feeding can be resumed after four hours. There is no restriction to daily activities. The swallowed capsule will be expelled naturally after 5 to 12 hours virtually in all patients. The risk of capsule retention is very low and only occurs in patients with severe small bowel stricture.
This study aims to assess the incidence and etiology of lower GI bleeding in patients presenting with tarry stool. The result will provide important information about the magnitude of the problem of lower GI bleeding that will improve our patient care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NSAID | Other | patients taking NSAID will undergo capsule endoscopy |
|
| Aspirin | Other | patients taking Aspirin will undergo capsule endoscopy |
|
| Non-user | Other | patients didn't take NSAID or ASA will undergo capsule endoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capsule endoscopy | Procedure | Capsule endoscopy and colonoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic yield of capsule endoscopy as the primary investigation for small bowel after negative esophagogastroduodenoscopy | 48 hours |
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Consecutive patients with a clinical diagnosis of upper gastrointestinal bleeding will be enrolled if they meet all of the following criteria:
Presence of melena or melena concomitant with PR bleeding;
Gastroscopic findings not accountable for the upper GI bleeding including: (i) clean base ulcers /erosions (refer to User Groups below) without high-risk stigmata, fresh or altered blood but can have grade A or B esophagitis concomitantly ; and (ii) meet the criteria of either the User groups or Non-user group as below
User Groups Definition: Patients who used any dose of NSAIDs or aspirin via oral or systemic (intramuscular, Per rectal) route within 2 weeks prior to the onset of upper GI bleeding NSAID group: Clean base gastric or duodenal ulcer is required (i.e., patients with normal finding or erosions alone on endoscopy will not be eligible) Aspirin group: Either an ulcer or multiple (>5) erosions found on endoscopy
Non-user group
Definition :
Age ³18;
Willing to meet the capsule endoscopy procedure requirements, and have provided written informed consent prior to admission to this study.
Concomitant clean base GU and DU can be recruited
Exclusion criteria
The presence of any of the following will exclude a subject from study enrollment:
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| Name | Affiliation | Role |
|---|---|---|
| Francis KL Chan, MD | CUHK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endoscopy Center in Prince of Wales Hospital | Hong Kong (sar) | China |
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| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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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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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013514 | Surgical Procedures, Operative |