Trial Outcomes & Findings for Comparing Early Capsule Deployment to Current Standard of Care for Management of Gastrointestinal Bleeding (NCT NCT02442830)

Last Updated: 2018-08-07

Results Overview

Time to localization of bleeding refers to the time after a patient is admitted to the emergency room and a bleeding source is localized. We defined localization of bleeding as endoscopic visualization of stigmata of recent hemorrhage.

Recruitment status

COMPLETED

Study phase

Target enrollment

87 participants

Primary outcome timeframe

Enrollment to localization of bleeding as measured in hours, up to 720 hours, whichever is sooner.

Results posted on

2018-08-07

Participant Flow

Participant milestones

Participant milestones
Measure	Early Video Capsule Endoscopy The intervention for subjects in this arm will be to have a video capsule (VC) deployed as soon as possible after presentation to the emergency department. Information from the VC will be obtained and reviewed to determine location of bleeding. Once that information has been obtained a decision will be made on which endoscopic test is most pertinent in finding and treating the source of bleeding. Early VC Endoscopy (VCE): The intervention is the use of VCE as the first test in a patient presenting to the Emergency Department (ED) with active bleeding. The capsule allows for visualization of the entire bowel. Once a capsule has been given to a study patient, a staff member will use the capsule's real-time viewer to see if there is any active bleeding in the stomach. If bleeding is seen the investigators will pursue an upper endoscopy. If no bleeding is seen a staff member will review the entire findings of the VCE and make a decision regarding which therapeutic measure to pursue.	Standard of Care Workup Group In this arm, patients will receive "standard of care workup" for non-hematemesis gastrointestinal bleeding. This could include upper endoscopy, colonoscopy, and additional capsule or small bowel enteroscopy depending on the subject's presentation and the results of the workup performed by the gastroenterology team. For patients requiring a video capsule endoscopy as part of "standard of care workup" the patients will be given the same Olympus video capsule that is used in the "Early Capsule" group.
Overall Study STARTED	42	45
Overall Study COMPLETED	42	44
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Early Video Capsule Endoscopy The intervention for subjects in this arm will be to have a video capsule (VC) deployed as soon as possible after presentation to the emergency department. Information from the VC will be obtained and reviewed to determine location of bleeding. Once that information has been obtained a decision will be made on which endoscopic test is most pertinent in finding and treating the source of bleeding. Early VC Endoscopy (VCE): The intervention is the use of VCE as the first test in a patient presenting to the Emergency Department (ED) with active bleeding. The capsule allows for visualization of the entire bowel. Once a capsule has been given to a study patient, a staff member will use the capsule's real-time viewer to see if there is any active bleeding in the stomach. If bleeding is seen the investigators will pursue an upper endoscopy. If no bleeding is seen a staff member will review the entire findings of the VCE and make a decision regarding which therapeutic measure to pursue.	Standard of Care Workup Group In this arm, patients will receive "standard of care workup" for non-hematemesis gastrointestinal bleeding. This could include upper endoscopy, colonoscopy, and additional capsule or small bowel enteroscopy depending on the subject's presentation and the results of the workup performed by the gastroenterology team. For patients requiring a video capsule endoscopy as part of "standard of care workup" the patients will be given the same Olympus video capsule that is used in the "Early Capsule" group.
Overall Study Technical Failure	0	1

Baseline Characteristics

Comparing Early Capsule Deployment to Current Standard of Care for Management of Gastrointestinal Bleeding

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Early Video Capsule Endoscopy n=42 Participants The intervention for subjects in this arm will be to have a video capsule (VC) deployed as soon as possible after presentation to the emergency department. Information from the VC will be obtained and reviewed to determine location of bleeding. Once that information has been obtained a decision will be made on which endoscopic test is most pertinent in finding and treating the source of bleeding. Early Video Capsule Endoscopy: The intervention is the use of video capsule endoscopy as the first test in a patient presenting to the ED with active bleeding. The capsule allows for visualization of the entire GI tract. Once a capsule has been given to a study patient, a staff member will use the capsule's real-time viewer to see if there is any active bleeding in the stomach. If bleeding is seen the investigators will pursue an upper endoscopy. If no bleeding is seen a staff member will review the entire findings of the capsule and make a decision regarding which therapeutic me	Standard of Care Workup Group n=45 Participants In this arm, patients will receive "standard of care workup" for non-hematemesis gastrointestinal bleeding. This could include upper endoscopy, colonoscopy, and additional capsule or small bowel enteroscopy depending on the subject's presentation and the results of the workup performed by the gastroenterology team. For patients requiring a video capsule endoscopy as part of "standard of care workup" the patients will be given the same Olympus video capsule that is used in the "Early Capsule" group.	Total n=87 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants	13 Participants n=7 Participants	34 Participants n=5 Participants
Age, Categorical >=65 years	21 Participants n=5 Participants	32 Participants n=7 Participants	53 Participants n=5 Participants
Age, Continuous	67.0 years STANDARD_DEVIATION 12.6 • n=5 Participants	70.4 years STANDARD_DEVIATION 16.4 • n=7 Participants	68.7 years STANDARD_DEVIATION 14.7 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	17 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	28 Participants n=7 Participants	51 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=5 Participants	43 Participants n=7 Participants	82 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	36 Participants n=5 Participants	42 Participants n=7 Participants	78 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	42 Participants n=5 Participants	45 Participants n=7 Participants	87 Participants n=5 Participants
Type of bleeding at admission Melena	26 Participants n=5 Participants	34 Participants n=7 Participants	60 Participants n=5 Participants
Type of bleeding at admission Hematochezia	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Type of bleeding at admission Symptomatic anemia	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Enrollment to localization of bleeding as measured in hours, up to 720 hours, whichever is sooner.

Outcome measures

Outcome measures
Measure	Early Video Capsule Endoscopy n=42 Participants The intervention for subjects in this arm will be to have a video capsule (VC) deployed as soon as possible after presentation to the emergency department. Information from the VC will be obtained and reviewed to determine location of bleeding. Once that information has been obtained a decision will be made on which endoscopic test is most pertinent in finding and treating the source of bleeding. Early Video Capsule Endoscopy: The intervention is the use of video capsule endoscopy as the first test in a patient presenting to the ED with active bleeding. The capsule allows for visualization of the entire GI tract. Once a capsule has been given to a study patient, a staff member will use the capsule's real-time viewer to see if there is any active bleeding in the stomach. If bleeding is seen the investigators will pursue an upper endoscopy. If no bleeding is seen a staff member will review the entire findings of the capsule and make a decision regarding which therapeutic me	Standard of Care Workup Group n=45 Participants In this arm, patients will receive "standard of care workup" for non-hematemesis gastrointestinal bleeding. This could include upper endoscopy, colonoscopy, and additional capsule or small bowel enteroscopy depending on the subject's presentation and the results of the workup performed by the gastroenterology team. For patients requiring a video capsule endoscopy as part of "standard of care workup" the patients will be given the same Olympus video capsule that is used in the "Early Capsule" group.
Time to Localization of Bleeding	21 hours Interval 9.0 to 31.0	16 hours Interval 13.0 to 31.0

SECONDARY outcome

Timeframe: Patient's will be assessed for the duration of their hospital stay and for thirty days afterwards.

This measurement counts the number of participants with a bleeding source localized by the end of admission.

Outcome measures

Outcome measures
Measure	Early Video Capsule Endoscopy n=42 Participants The intervention for subjects in this arm will be to have a video capsule (VC) deployed as soon as possible after presentation to the emergency department. Information from the VC will be obtained and reviewed to determine location of bleeding. Once that information has been obtained a decision will be made on which endoscopic test is most pertinent in finding and treating the source of bleeding. Early Video Capsule Endoscopy: The intervention is the use of video capsule endoscopy as the first test in a patient presenting to the ED with active bleeding. The capsule allows for visualization of the entire GI tract. Once a capsule has been given to a study patient, a staff member will use the capsule's real-time viewer to see if there is any active bleeding in the stomach. If bleeding is seen the investigators will pursue an upper endoscopy. If no bleeding is seen a staff member will review the entire findings of the capsule and make a decision regarding which therapeutic me	Standard of Care Workup Group n=45 Participants In this arm, patients will receive "standard of care workup" for non-hematemesis gastrointestinal bleeding. This could include upper endoscopy, colonoscopy, and additional capsule or small bowel enteroscopy depending on the subject's presentation and the results of the workup performed by the gastroenterology team. For patients requiring a video capsule endoscopy as part of "standard of care workup" the patients will be given the same Olympus video capsule that is used in the "Early Capsule" group.
Number of Participants With Localization of Bleeding by the End of Admission	27 Participants	15 Participants

Adverse Events

Early Video Capsule Endoscopy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Standard of Care Workup Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Principal Investigator

UMass Medical School

Phone: (774) 442-4098

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place