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Endoscopic Evaluation of Lower Gastrointestinal Bleeding (GIB) in Patients Presenting With Melena

Primary Purpose

Gastrointestinal Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Capsule endoscopy
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastrointestinal Hemorrhage focused on measuring Capsule Endoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Endoscopy Center in Prince of Wales Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

NSAID

Aspirin

Non-user

Arm Description

patients taking NSAID will undergo capsule endoscopy

patients taking Aspirin will undergo capsule endoscopy

patients didn't take NSAID or ASA will undergo capsule endoscopy

Outcomes

Primary Outcome Measures

Diagnostic yield of capsule endoscopy as the primary investigation for small bowel after negative esophagogastroduodenoscopy

Secondary Outcome Measures

Full Information

First Posted
September 9, 2005
Last Updated
August 10, 2015
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT00164723
Brief Title
Endoscopic Evaluation of Lower Gastrointestinal Bleeding (GIB) in Patients Presenting With Melena
Official Title
Endoscopic Evaluation of the Incidence and Etiology of Lower Gastrointestinal Bleeding in Patients Presenting With Melena
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Hemorrhage
Keywords
Capsule Endoscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NSAID
Arm Type
Other
Arm Description
patients taking NSAID will undergo capsule endoscopy
Arm Title
Aspirin
Arm Type
Other
Arm Description
patients taking Aspirin will undergo capsule endoscopy
Arm Title
Non-user
Arm Type
Other
Arm Description
patients didn't take NSAID or ASA will undergo capsule endoscopy
Intervention Type
Procedure
Intervention Name(s)
Capsule endoscopy
Intervention Description
Capsule endoscopy and colonoscopy
Primary Outcome Measure Information:
Title
Diagnostic yield of capsule endoscopy as the primary investigation for small bowel after negative esophagogastroduodenoscopy
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis KL Chan, MD
Organizational Affiliation
CUHK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endoscopy Center in Prince of Wales Hospital
City
Hong Kong (SAR)
Country
China

12. IPD Sharing Statement

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Endoscopic Evaluation of Lower Gastrointestinal Bleeding (GIB) in Patients Presenting With Melena

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