Status:
COMPLETED
Endoscopic Evaluation of Lower Gastrointestinal Bleeding (GIB) in Patients Presenting With Melena
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Gastrointestinal Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To evaluate the incidence and etiology of small bowel or large bowel bleeding in patients presenting with melena.
Detailed Description
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 smal...
Eligibility Criteria
Inclusion
- 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 :
- No continuous use of NSAIDs or aspirin for more than 1 week within the past 3 Months and patients who had not been exposed to NSAIDs, aspirin, or unknown drugs ≥ 4 weeks prior to GI bleed;
- Clean base gastric or duodenal ulcer is required (i.e., patients with normal finding or erosions alone on OGD will not be eligible)
- 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:
- Hematemesis as the presenting symptom;
- Gastroscopic findings accountable for the bleeding episode (i.e., presence of blood in the stomach, ulcers showing high-risk bleeding stigmata, bleeding gastroesophageal varices, Mallory-Weiss tear showing bleeding stigmata, portohypertensive gastropathy);
- Gastroscopic findings are normal.
- Uncontrolled bleeding requiring emergency surgery or mesenteric angiography;
- Has cardiac pacemaker or other electromedical implant;
- Is expected to undergo MRI examination or be in the vicinity of powerful electromagnetic fields between ingesting the capsule and its excretion;
- Active malignancy or history of a malignancy within 5 years prior to enrollment;
- Previous gastric surgery;
- Known or suspected complete or partial stenosis of the small intestine;
- Established delayed gastric emptying or diabetic gastroparesis;
- Known inflammatory bowel disease;
- Use of misoprostol within the 2 weeks prior to admission;
- Concomitant use of NSAIDs and aspirin;
- Currently taking anticoagulants or lithium;
- Has a swallowing disorder that precludes safe ingestion of the capsule;
- Pregnancy;
- History of clinically significant substance abuse, drug addiction or a history of chronic ingestion of more than two alcoholic drinks per day;
- Any mental or physical condition, which precludes compliance with study and/or device instructions;
- Received any investigational medication within 30 days prior to the treatment period;
- Currently participating in another clinical study that may affect the results of this study.
- Ulcer \> 2cm
- clean base ulcer with grade C or D esophagitis
Exclusion
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT00164723
Start Date
February 1 2005
End Date
November 1 2014
Last Update
August 13 2015
Active Locations (1)
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1
Endoscopy Center in Prince of Wales Hospital
Hong Kong (sar), China