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

Gastrointestinal Hemorrhage Clinical Trial

Official title:

Video Capsule Endoscopy Versus Colonoscopy in Patients With Melena and Negative Upper Endoscopy: A Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02609100
• Other study ID #: 201507101
• Status: Terminated
• Phase: N/A
• Start date: November 2015
• Est. completion date: December 6, 2016

Study information

• Verified date: June 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: December 6, 2016
• Est. primary completion date: December 6, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

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

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage

Intervention

Procedure:
• Video Capsule Endoscopy
Video Capsule Endoscopy allows for imaging of the small intestine between the distant duodeno-jejunal junction, which is beyond the reach of upper GI endoscopy and the terminal ileum and is similarly beyond the reach of colonoscopy. It is of greatest use in identifying points of bleeding and ulcers.
• Colonoscopy
The colonoscopy helps find ulcers, tumors, and areas of inflammation or bleeding in the large intestine.

Device:
• 1.0 X 2.5 cm 'pill' containing a camera

Locations

Country	Name	City	State
United States	Center for Advanced Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Up to twenty four hours
Primary	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	Colonoscopy identifies clinically significant lesions defined as lesions considered to have high potential for bleeding, such as a large ulceration, tumor or typical angiomata	Up to one hour
Secondary	Therapeutic Yield of Video Capsule Endoscopy	Therapeutic yield of video capsule endoscopy is defined as the proportion of endoscopies leading to a therapeutic intervention.	Up to 7 days
Secondary	Therapeutic Yield of Colonoscopy	Therapeutic yield of colonoscopy is defined as the proportion of endoscopies leading to a therapeutic intervention.	Up to 7 days
Secondary	Number of Blood Units Transfused	Number of blood units transfused measured in units of packed red blood cells	Up to 60 days
Secondary	Number of Diagnostic Studies Performed for Evaluation of Gastrointestinal Bleeding	Includes repeat endoscopies or imaging	Up to 60 days
Secondary	Duration of Hospital Stay	The duration of hospital stay will be recorded in number of days	Up to 60 days
Secondary	Procedure Related Adverse Events	Adverse events related to the video capsule endoscopy and colonoscopy will be recorded	Up to 60 days