Clinical trial NCT02609100: Video Capsule Endoscopy Versus Colonoscopy in Patients With Melena and Negative Upper Endoscopy
Official title: Video Capsule Endoscopy Versus Colonoscopy in Patients With Melena and Negative Upper Endoscopy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gastrointestinal Hemorrhage
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Up to twenty four hours
measure: 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
timeFrame: Up to one hour
Secondary outcomes:
measure: Therapeutic Yield of Video Capsule Endoscopy
timeFrame: Up to 7 days
measure: Therapeutic Yield of Colonoscopy
timeFrame: Up to 7 days
measure: Number of Blood Units Transfused
timeFrame: Up to 60 days
measure: Number of Diagnostic Studies Performed for Evaluation of Gastrointestinal Bleeding
timeFrame: Up to 60 days
measure: Duration of Hospital Stay
timeFrame: Up to 60 days
measure: Procedure Related Adverse Events
timeFrame: Up to 60 days
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Center for Advanced Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Vladimir M Kushnir, MD
role: PRINCIPAL_INVESTIGATOR
References: