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

NCT ID: NCT02609100

Last Updated: 2018-06-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2016-12-06

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.

Conditions

Gastrointestinal Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Video Capsule Endoscopy

Intervention Type: PROCEDURE

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.

1.0 X 2.5 cm 'pill' containing a camera

Intervention Type: DEVICE

Next Day 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.

Group Type: ACTIVE_COMPARATOR

Colonoscopy

Intervention Type: PROCEDURE

The colonoscopy helps find ulcers, tumors, and areas of inflammation or bleeding in the large intestine.

Interventions

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.

Intervention Type: PROCEDURE

Colonoscopy

The colonoscopy helps find ulcers, tumors, and areas of inflammation or bleeding in the large intestine.

Intervention Type: PROCEDURE

1.0 X 2.5 cm 'pill' containing a camera

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vladimir M Kushnir, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Center for Advanced Medicine

St Louis, Missouri, United States

Countries

United States

Other Identifiers

201507101

Identifier Type: -

Identifier Source: org_study_id