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

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ClinicalTrials.gov Identifier: NCT02442830
Recruitment Status : Completed
First Posted : May 13, 2015
Results First Posted : August 7, 2018
Last Update Posted : August 7, 2018
Sponsor:
Collaborator:
Olympus Corporation
Information provided by (Responsible Party):
David Cave, University of Massachusetts, Worcester

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Melena
Gastrointestinal Hemorrhage
Intervention Device: Early Video Capsule Endoscopy
Enrollment 87
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Early Video Capsule Endoscopy Standard of Care Workup Group
Hide Arm/Group Description

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.

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.
Period Title: Overall Study
Started 42 45
Completed 42 44
Not Completed 0 1
Reason Not Completed
Technical Failure             0             1
Arm/Group Title Early Video Capsule Endoscopy Standard of Care Workup Group Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 42 45 87
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 45 participants 87 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
21
  50.0%
13
  28.9%
34
  39.1%
>=65 years
21
  50.0%
32
  71.1%
53
  60.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 45 participants 87 participants
67.0  (12.6) 70.4  (16.4) 68.7  (14.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 45 participants 87 participants
Female
19
  45.2%
17
  37.8%
36
  41.4%
Male
23
  54.8%
28
  62.2%
51
  58.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 45 participants 87 participants
Hispanic or Latino
3
   7.1%
2
   4.4%
5
   5.7%
Not Hispanic or Latino
39
  92.9%
43
  95.6%
82
  94.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 45 participants 87 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   7.1%
1
   2.2%
4
   4.6%
White
36
  85.7%
42
  93.3%
78
  89.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   7.1%
2
   4.4%
5
   5.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 42 participants 45 participants 87 participants
42
 100.0%
45
 100.0%
87
 100.0%
Type of bleeding at admission  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 45 participants 87 participants
Melena
26
  61.9%
34
  75.6%
60
  69.0%
Hematochezia
11
  26.2%
9
  20.0%
20
  23.0%
Symptomatic anemia
5
  11.9%
2
   4.4%
7
   8.0%
1.Primary Outcome
Title Time to Localization of Bleeding
Hide Description 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.
Time Frame Enrollment to localization of bleeding as measured in hours, up to 720 hours, whichever is sooner.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early Video Capsule Endoscopy Standard of Care Workup Group
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 42 45
Median (Inter-Quartile Range)
Unit of Measure: hours
21
(9 to 31)
16
(13 to 31)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Video Capsule Endoscopy
Comments [Not Specified]
Type of Statistical Test Other
Comments Log rank test
Statistical Test of Hypothesis P-Value .002
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Localization of Bleeding by the End of Admission
Hide Description This measurement counts the number of participants with a bleeding source localized by the end of admission.
Time Frame Patient's will be assessed for the duration of their hospital stay and for thirty days afterwards.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early Video Capsule Endoscopy Standard of Care Workup Group
Hide Arm/Group Description:

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 VC 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 measure to pursue.

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 Number of Participants Analyzed 42 45
Measure Type: Count of Participants
Unit of Measure: Participants
27
  64.3%
15
  33.3%
Time Frame 30 days
Adverse Event Reporting Description Adverse events were collected only if they were considered procedure-related.
 
Arm/Group Title Early Video Capsule Endoscopy Standard of Care Workup Group
Hide Arm/Group Description

The intervention for subjects in this arm will be to have a video capsule deployed as soon as possible after presentation to the emergency department. Information from the video capsule 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

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.
All-Cause Mortality
Early Video Capsule Endoscopy Standard of Care Workup Group
Affected / at Risk (%) Affected / at Risk (%)
Total   1/42 (2.38%)   2/45 (4.44%) 
Show Serious Adverse Events Hide Serious Adverse Events
Early Video Capsule Endoscopy Standard of Care Workup Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/42 (0.00%)   0/45 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Early Video Capsule Endoscopy Standard of Care Workup Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/42 (0.00%)   0/45 (0.00%) 
The study was performed in a single center with a relatively homogeneous population. Study personnel were not blinded to group allocation following randomization.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Principal Investigator
Organization: UMass Medical School
Phone: (774) 442-4098
Publications:
Jawaid S, Gondal B, Singh, A, Marshall C, and Cave D. The epidemiology of gastrointestinal bleeding in an academic emergency department as a basis for reconfiguring the conventional approach to its diagnosis and management. Gastrointestinal Endsocopy 2013;77:Supplement, Page AB483.
Jawaid S, Marya N, Gondal B, Maranda L, Marshall C, Charpentier J, Singh A, Foley A, and Cave D. . A reconsideration of the diagnosis and management of gastrointestinal bleeding based on its epidemiology and outcomes analysis. Gastrointestinal Endsocopy 2014;79:Supplement, Page AB231.
Responsible Party: David Cave, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT02442830     History of Changes
Other Study ID Numbers: H00006661
First Submitted: April 23, 2015
First Posted: May 13, 2015
Results First Submitted: June 26, 2018
Results First Posted: August 7, 2018
Last Update Posted: August 7, 2018