Upper Gastrointestinal BleedingNCT02446678
Use of PillCam ESO2 in Triaging Patients Present With Upper GIB
A study testing PillCam ESO2 in people with Upper Gastrointestinal Bleeding, run by Chinese University of Hong Kong.
Trial summary
Background Patients presented to hospital with coffee ground vomiting and black stool may not be actually having upper gastrointestinal bleeding (UGIB) Hospital admission can be avoided if serious UGIB can be excluded To date, the only useful tool to triage patient for hospital admission in UGIB is by using clinical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Gastrointestinal Bleeding
- What is being tested?
- PillCam ESO2
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individual aged ≥ 18 years presenting to the emergency department with acute, overt UGIB defined as coffee ground vomiting and/or melena
Who cannot join
- UGIB with hemodynamic shock (BP<90mmHg and pulse>120 per minutes) requiring urgent endoscopy,
- UGIB with fresh hematemesis requiring urgent endoscopy
- dysphagia, odynophagia, swallowing disorder, Zencker's diverticulum, suspected bowel obstruction or bowel perforation,
- prior bowel obstruction, gastroparesis or known gastric outlet obstruction, Crohn's disease, past GI tract surgery.
- presence of an electromedical device (pacemaker or internal cardiac defibrillator),
- altered mental status (e.g., hepatic encephalopathy) that would limit patient ability in swallowing the capsule, pregnancy and/or lactating, allergy to conscious sedation medications, allergy to Maxolon, unwillingness to swallow the capsule, patient expected to undergo Magnetic Resonance Imaging examination within 7 days of ingesting the capsule, patient on medications that may coat the upper GI tract such as antacids or sucralfate, or inability to provide written informed consent.
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- Allergy to Maxolon
- Patients with known Esophageal Varices or Gastric Varices with or without prior bleeding episodes
- Known upper/ lower GI cancer (eg, cancer of esophagus, stomach, small bowel, colon) or hepatocellular carcinoma or pancreatic cancer
About this study
Official title: The Use Of PillCam Esophagus In Triaging Patients Presented With Upper Gastrointestinal Bleeding
Background
- Patients presented to hospital with coffee ground vomiting and black stool may not be actually having upper gastrointestinal bleeding (UGIB)
- Hospital admission can be avoided if serious UGIB can be excluded
- To date, the only useful tool to triage patient for hospital admission in UGIB is by using clinical score such as Rockall score or Blatchford score
- These scores are cumbersome and only exclude the most benign cases, but they are not useful in differentiating those who needs intervention
- In our pilot study, investigators found that capsule endoscopy can be used to identify patients with fresh blood and real coffee ground substance in the stomach and it is superior to nasogastric tube
- Most of UGI lesions leading to bleeding can be diagnosed by capsule endoscopy
Read more
Objectives The current study is designed
- to validate capsule endoscopy is an effective method in identifying patients with UGIB
- to study whether the capsule endoscopy can reduce requirement of hospital admission in patients with suspected UGIB
- to study if capsule endoscopy can help to identify patients with UGIB that may require urgent (within 24 hours) endoscopy and intervention
- to study the cost-effectiveness of capsule endoscopy being used as a triaging tool in the management of UGIB
- to compare the effectiveness of capsule endoscopy against Blatchford score in identifying patients with UGIB that may require endoscopic intervention.
Read the detailed description
Hypothesis PillCam Esophagus is effective in identifying genuine UGIB and hence able to reduce hospital admission due to unsubstantiated UGIB cases
Methodology
- Patients presented to the Accident \& Emergency Department (A\&ED) of the Prince of Wales Hospital Hong Kong with symptoms suggestive of UGIB will be recruited into this study
- Patients will receive the following tests
- Complete blood count
- Coagulation profile
- Renal and liver function tests
- Hourly BP, Pulse up to 6 hours
- Glasgow Blatchford score calculated on admission
- Randomization
- Capsule Group: Capsule Endoscopy (CE) by using PillCam Esophagus (PillCam ESO) OR
- Standard group: Hospitalization and Standard of Care
- The video in capsule endoscopy will be read by trained personnel who have undergone at least one hour lecture about realtime reviewing.
- Legally a patient has to be signed off by a clinician within 6 hours. The finding of fresh blood or coffee ground will be documented. Upper GI pathology that may lead to bleeding will also be recorded.
Capsule Endoscopy (CE) After confirming patient has been fasted for at least 5 hours, the subject ingested the PillCam® ESO 2 (Given Imaging Ltd., Yoqneam, Israel) (PillCam ESO) using the Simplified Ingestion Procedure.
Thirty to sixty minutes prior to capsule ingestion, each subject received a single dose of intravenous Maxolon 10mg. Intravenous Maxolon, through its motilin receptor agonist effect, has been shown to promote gastric motility and improve visualization of the gastric mucosa at endoscopy. Moreover, use of Maxolon was thought to facilitate the capsule entering the duodenum.
Using the REAL time viewer, UGI tract images (esophagus to the second portion of the duodenum) were obtained in real time at the patient's bedside. The video images that are transmitted by the PillCam ESO 2 are displayed in real time on the tablet computer screen.
Each subject is also fitted with and wore the standard CE sensor array and data recorder so that a full-length CE video recording can be obtained for subsequent capsule workstation downloading and complete review.
Other demographic data and parameters for Blatchford score calculation will be collected. 10 ml of blood will be taken for routine blood checking. Patients will receive standard care according to EGD findings.
- Conditions
- Upper Gastrointestinal Bleeding
- Being tested
- PillCam ESO2
- Keywords
- Gastrointestinal bleeding, emergency department, PillCam ESO2
- Medical subject headings
- Gastrointestinal Hemorrhage, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PillCam ESO2Device
Capsule endoscopy
| Study group | Role | What they receive |
|---|---|---|
| Capsule group: PillCam ESO2 | Active comparator | Perform capsule endoscopy and esophagogastroduodenoscopy will be preformed within 24 hours after capsule ingestion Receives: Device: PillCam ESO2 |
| Standard group | No intervention | Perform standard esophagogastroduodenoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients requiring hospital admission
Patients with evidence of significant bleeding will be admitted to ward and receive early endoscopy (EGD)
Measured: 24 hours
Secondary outcomes (4)
Clinical rebleeding
Recurrent GI bleeding
Measured: 30 days
Mortality
Death rate
Measured: 30 days
Cost of management in different strategies
Cost of management in different strategies
Measured: One year
Comparing the effectiveness of CE against Glasgow Blatchford score in identifying patients with UGIB that may require endoscopic intervention
Using Glasgow Blatchford score
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2015 (estimated)
- Study startNov 2013
- Primary completionApr 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Gastrointestinal BleedingStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph JY SUNG, Chinese University of Hong Kong
- Investigators
- Jessica Y.L. Ching, MPH, Study director, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02446678
- Sponsor's protocol ID
- ESO2
- Status last verified
- Apr 2017
- First submitted
- 12 May 2015
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sung JJ, Tang RS, Ching JY, Rainer TH, Lau JY. Use of capsule endoscopy in the emergency department as a triage of patients with GI bleeding. Gastrointest Endosc. 2016 Dec;84(6):907-913. doi: 10.1016/j.gie.2016.04.043. Epub 2016 May 6.
PubMed 27156655
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use Of PillCam Esophagus In Triaging Patients Presented With Upper Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT02446678
- Acronym / sponsor ID
- ESO2
- Conditions
- Upper Gastrointestinal Bleeding
- Keywords
- Gastrointestinal bleeding, emergency department, PillCam ESO2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 18 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background
- Patients presented to hospital with coffee ground vomiting and black stool may not be actually having upper gastrointestinal bleeding (UGIB)
- Hospital admission can be avoided if serious UGIB can be excluded
- To date, the only useful tool to triage patient for hospital admission in UGIB is by using clinical score such as Rockall score or Blatchford score
- These scores are cumbersome and only exclude the most benign cases, but they are not useful in differentiating those who needs intervention
- In our pilot study, investigators found that capsule endoscopy can be used to identify patients with fresh blood and real coffee ground substance in the stomach and it is superior to nasogastric tube
- Most of UGI lesions leading to bleeding can be diagnosed by capsule endoscopy
Objectives The current study is designed
- to validate capsule endoscopy is an effective method in identifying patients with UGIB
- to study whether the capsule endoscopy can reduce requirement of hospital admission in patients with suspected UGIB
- to study if capsule endoscopy can help to identify patients with UGIB that may require urgent (within 24 hours) endoscopy and intervention
- to study the cost-effectiveness of capsule endoscopy being used as a triaging tool in the management of UGIB
- to compare the effectiveness of capsule endoscopy against Blatchford score in identifying patients with UGIB that may require endoscopic intervention.
Detailed description
Hypothesis PillCam Esophagus is effective in identifying genuine UGIB and hence able to reduce hospital admission due to unsubstantiated UGIB cases
Methodology
- Patients presented to the Accident \& Emergency Department (A\&ED) of the Prince of Wales Hospital Hong Kong with symptoms suggestive of UGIB will be recruited into this study
- Patients will receive the following tests
- Complete blood count
- Coagulation profile
- Renal and liver function tests
- Hourly BP, Pulse up to 6 hours
- Glasgow Blatchford score calculated on admission
- Randomization
- Capsule Group: Capsule Endoscopy (CE) by using PillCam Esophagus (PillCam ESO) OR
- Standard group: Hospitalization and Standard of Care
- The video in capsule endoscopy will be read by trained personnel who have undergone at least one hour lecture about realtime reviewing.
- Legally a patient has to be signed off by a clinician within 6 hours. The finding of fresh blood or coffee ground will be documented. Upper GI pathology that may lead to bleeding will also be recorded.
Capsule Endoscopy (CE) After confirming patient has been fasted for at least 5 hours, the subject ingested the PillCam® ESO 2 (Given Imaging Ltd., Yoqneam, Israel) (PillCam ESO) using the Simplified Ingestion Procedure.
Thirty to sixty minutes prior to capsule ingestion, each subject received a single dose of intravenous Maxolon 10mg. Intravenous Maxolon, through its motilin receptor agonist effect, has been shown to promote gastric motility and improve visualization of the gastric mucosa at endoscopy. Moreover, use of Maxolon was thought to facilitate the capsule entering the duodenum.
Using the REAL time viewer, UGI tract images (esophagus to the second portion of the duodenum) were obtained in real time at the patient's bedside. The video images that are transmitted by the PillCam ESO 2 are displayed in real time on the tablet computer screen.
Each subject is also fitted with and wore the standard CE sensor array and data recorder so that a full-length CE video recording can be obtained for subsequent capsule workstation downloading and complete review.
Other demographic data and parameters for Blatchford score calculation will be collected. 10 ml of blood will be taken for routine blood checking. Patients will receive standard care according to EGD findings.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capsule group: PillCam ESO2 | Active comparator | Device: PillCam ESO2Perform capsule endoscopy and esophagogastroduodenoscopy will be preformed within 24 hours after capsule ingestion |
| Standard group | No intervention | –Perform standard esophagogastroduodenoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individual aged ≥ 18 years presenting to the emergency department with acute, overt UGIB defined as coffee ground vomiting and/or melena
Key exclusion criteria (9 listed)
- UGIB with hemodynamic shock (BP<90mmHg and pulse>120 per minutes) requiring urgent endoscopy,
- UGIB with fresh hematemesis requiring urgent endoscopy
- dysphagia, odynophagia, swallowing disorder, Zencker's diverticulum, suspected bowel obstruction or bowel perforation,
- prior bowel obstruction, gastroparesis or known gastric outlet obstruction, Crohn's disease, past GI tract surgery.
- presence of an electromedical device (pacemaker or internal cardiac defibrillator),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PillCam ESO2Capsule endoscopy | Device | Capsule group: PillCam ESO2 |
Primary outcome
The number of patients requiring hospital admission
Time frame: 24 hours
Patients with evidence of significant bleeding will be admitted to ward and receive early endoscopy (EGD)
4 secondary outcomes
Clinical rebleeding
Time frame: 30 days
Mortality
Time frame: 30 days
Cost of management in different strategies
Time frame: One year
Comparing the effectiveness of CE against Glasgow Blatchford score in identifying patients with UGIB that may require endoscopic intervention
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Derived from this study: PubMed 27156655Sung JJ, Tang RS, Ching JY, Rainer TH, Lau JY. Use of capsule endoscopy in the emergency department as a triage of patients with GI bleeding. Gastrointest Endosc. 2016 Dec;84(6):907-913. doi: 10.1016/j.gie.2016.04.043. Epub 2016 May 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Y.L. Ching, MPH study director
Chinese University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A study testing PillCam ESO2 in people with Upper Gastrointestinal Bleeding, run by Chinese University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients requiring hospital admission (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02446678, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2017; AzTrials last refreshed its copy on 7 Nov 2026.