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

NCT02609100 | Terminated Results

• 1 other identifier: 201507101
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Therapeutic Yield of Video Capsule Endoscopy

  Up to 7 days

• Therapeutic Yield of Colonoscopy

  Up to 7 days

• Number of Blood Units Transfused

  Up to 60 days

• Number of Diagnostic Studies Performed for Evaluation of Gastrointestinal Bleeding

  Up to 60 days

• Duration of Hospital Stay

  Up to 60 days

Study Arms (2)

Video Capsule Endoscopy

ACTIVE COMPARATOR

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.

Procedure: Video Capsule Endoscopy; Device: 1.0 X 2.5 cm 'pill' containing a camera

Next Day Colonoscopy

ACTIVE COMPARATOR

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.

Procedure: Colonoscopy

Interventions

Video Capsule Endoscopy 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.

Video Capsule Endoscopy

Colonoscopy PROCEDURE

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

Next Day Colonoscopy

1.0 X 2.5 cm 'pill' containing a camera DEVICE

Video Capsule Endoscopy

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Center for Advanced Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Videotape Recording; Endoscopy; Colonoscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Digestive System Surgical Procedures

Limitations and Caveats

Overall limit is that study was stopped and closed after only four successful enrollments.

Results Point of Contact

• Title: Dr. Vladimir M. Kushnir
• Organization: Washington University School of Medicine in St. Louis

vkushnir@wustl.edu

314-362-3685

Study Officials

• Vladimir M Kushnir, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2015
• First Posted: November 20, 2015
• Study Start: November 1, 2015
• Primary Completion: December 6, 2016
• Study Completion: December 6, 2016
• Last Updated: June 20, 2018
• Results First Posted: June 20, 2018

Record last verified: 2018-06

Locations

US (1)