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

NCT00164723 | Completed

• 1 other identifier: CE_GIB
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the incidence and etiology of small bowel or large bowel bleeding in patients presenting with melena.

Conditions

Gastrointestinal Hemorrhage

Keywords

Capsule Endoscopy

Outcome Measures

Primary Outcomes (1)

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

  48 hours

Study Arms (3)

NSAID

OTHER

patients taking NSAID will undergo capsule endoscopy

Procedure: Capsule endoscopy

Aspirin

OTHER

patients taking Aspirin will undergo capsule endoscopy

Procedure: Capsule endoscopy

Non-user

OTHER

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

Procedure: Capsule endoscopy

Interventions

Capsule endoscopy PROCEDURE

Capsule endoscopy and colonoscopy

Aspirin; NSAID; Non-user

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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;

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Endoscopy Center in Prince of Wales Hospital

Hong Kong (sar), China

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Francis KL Chan, MD

  CUHK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 14, 2005
• Study Start: February 1, 2005
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: August 13, 2015

Record last verified: 2011-01

Locations

CN (1)