Video Capsule Endoscopy Versus Colonoscopy in Patients With Melena and Negative Upper Endoscopy

Not Applicable

Terminated

• Conditions: Gastrointestinal Hemorrhage
• Interventions: Procedure: Video Capsule Endoscopy; Procedure: Colonoscopy; Device: 1.0 X 2.5 cm 'pill' containing a camera

• Registration Number: NCT02609100
• Lead Sponsor: Washington University School of Medicine

Brief Summary

Acute gastrointestinal bleeding is a common medical problem. When patients with gastrointestinal bleeding present with melena (dark, tarry stool) the blood loss is usually originating in the upper gastrointestinal tract (esophagus, stomach or duodenum) and first step in evaluating the patient is an upper endoscopy; which allows direct visualization of the esophagus, stomach and duodenum. However, the cause of bleeding is located in the small bowel or colon in 20-30% of patients who present with melena. Traditionally colonoscopy has been the next test preformed if upper endoscopy does not identify the cause of melena/ gastrointestinal bleeding, however less than 25% of patients who present with melena have bleeding originating in the colon, and the remainder of patients have bleeding originating in the small intestine, which can only be fully evaluated with video capsule endoscopy (a pill camera which is swallowed and takes pictures while it travels thought the small bowel and colon). Currently patients only undergo video capsule endoscopy if colonoscopy does not identify the cause of bleeding. The investigators are preforming a randomized study which seeks to determine if colonoscopy or video capsule endoscopy is a better way to identify the cause of gastrointestinal bleeding in patients who present with melena and have normal findings on upper endoscopy. To do this the investigators will enroll patients who present with melena prior to their upper endoscopy and if the cause of bleeding is not identified at that time patients will be randomized to video capsule endoscopy (with the capsule being placed into the small bowel during the upper endoscopy) or next day colonoscopy.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-16
• Study First Submitted QC: 2015-11-18
• Study First Posted: 2015-11-20
• Primary Completion: 2016-12-06
• Study Completion: 2016-12-06
• Results First Submitted: 2018-02-02
• Status Verified: 2018-06
• Results First Submitted QC: 2018-06-19
• Last Update Submitted: 2018-06-19
• Results First Posted: 2018-06-20
• Last Update Posted: 2018-06-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• Inpatients >18 years of age presenting with lower gastrointestinal bleeding and have melenic stool

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Exclusion Criteria

• Unable to provide written informed consent
• A probable bleeding source is identified on upper endoscopy
• Pregnancy or lactation
• Swallowing Disorder
• Unable to tolerate sedation or anesthesia due to medical co-morbidities
• Uncorrected coagulopathy (platelet count <50,000, INR> 2, PTT> 2x upper limit of normal)
• Known or suspected gastrointestinal obstruction or stricture
• Cardiac pacemaker or other implanted electromedical device
• Contraindication to bowel preparation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Video Capsule Endoscopy	Video Capsule Endoscopy	Randomization arm one is to video capsule endoscopy (VCE) a non-invasive procedure in which a patient swallows a disposable 1.0 X 2.5 cm 'pill' containing a camera electronically linked to equipment outside the patient which records images as it passes from the esophagus through the entire tract and is excreted in feces. It images the small intestine in areas beyond the reach of upper GI endoscopy and the terminal ileum and is similarly beyond the reach of colonoscopy. Its greatest use is in identifying points of bleeding and ulcers.
Next Day Colonoscopy	Colonoscopy	Randomization arm two is to colonoscopy, a test that allows the doctor to look at the inner lining of the large intestine (rectum and colon). He or she uses a thin, flexible tube called a colonoscope to look at the colon.
Video Capsule Endoscopy	1.0 X 2.5 cm 'pill' containing a camera	Randomization arm one is to video capsule endoscopy (VCE) a non-invasive procedure in which a patient swallows a disposable 1.0 X 2.5 cm 'pill' containing a camera electronically linked to equipment outside the patient which records images as it passes from the esophagus through the entire tract and is excreted in feces. It images the small intestine in areas beyond the reach of upper GI endoscopy and the terminal ileum and is similarly beyond the reach of colonoscopy. Its greatest use is in identifying points of bleeding and ulcers.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Clinically Significant Findings Defined as Lesions Considered to Have a High Potential for Bleeding to Participants With no Significant Findings From Video Capsule Endoscopy	Up to twenty four hours	Video Capsule Endoscopy identifies clinically significant lesions defined as lesions considered to have high potential for bleeding, such as a large ulceration, tumor or typical angiomata
Number of Participants With Clinically Significant Findings Defined as Lesions Considered to Have a High Potential for Bleeding to Participants With no Significant Findings From Colonoscopy	Up to one hour	Colonoscopy identifies clinically significant lesions defined as lesions considered to have high potential for bleeding, such as a large ulceration, tumor or typical angiomata

Secondary Outcome Measures

Name	Time	Method
Therapeutic Yield of Video Capsule Endoscopy	Up to 7 days	Therapeutic yield of video capsule endoscopy is defined as the proportion of endoscopies leading to a therapeutic intervention.
Therapeutic Yield of Colonoscopy	Up to 7 days	Therapeutic yield of colonoscopy is defined as the proportion of endoscopies leading to a therapeutic intervention.
Number of Blood Units Transfused	Up to 60 days	Number of blood units transfused measured in units of packed red blood cells
Number of Diagnostic Studies Performed for Evaluation of Gastrointestinal Bleeding	Up to 60 days	Includes repeat endoscopies or imaging
Duration of Hospital Stay	Up to 60 days	The duration of hospital stay will be recorded in number of days
Procedure Related Adverse Events	Up to 60 days	Adverse events related to the video capsule endoscopy and colonoscopy will be recorded

Trial Locations

Locations (1)

Center for Advanced Medicine; 🇺🇸 Saint Louis, Missouri, United States