Bleeding Peptic UlcerNCT00164827
Surveillance of Bleeding Peptic Ulcer Using Wireless Capsule Endoscopy
An observational study of Bleeding Peptic Ulcer, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
To investigate the adjunctive role of "Capsule Endoscope" in continuous endoscopic monitoring and early detection of recurrent ulcer bleeding after endoscopic therapy in patients presenting with bleeding peptic ulcers Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bleeding Peptic Ulcer
- What is being tested?
- Endoscopic placement of Capsule endoscope adjacent to the peptic ulcer
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Jan 2003to not given
- Phase
- Observational
- 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
- Patients with bleeding peptic ulcers; ulcer actively bleeding or with major stigmata of visible vessels ( protuberant discolorations in ulcer bases) and clots (Forrest I, IIa and IIb ulcers) seen at endoscopy performed within 24 hours of their admissions.
- Endoscopic hemostasis achieved (with defined endpoints).
- Age > 18
- Provision of an informed written consent signed by the patient.
Who cannot join
- The present of an intercurrent ulcer complication precluding endoscopic treatment such as gastric outlet obstruction or ulcer perforation mandating surgical intervention.
- Patients with clinical suspicion of intestinal obstruction, stricture and fistula.
- Patient with cardiac pacemaker, or any implanted electromedical device.
- Age <18
- Pregnancy
- moribund patients e.g. patients with terminal malignancy
- Patient unable to give written consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Endoscopy Center, Prince of Wales Hospital
Hong Kong
Enders KW Ng, MD, 26322627, endersng@surgery.cuhk.edu.hk
Philip WY Chiu, MBChB,FRCSEd, 26322627, pwychiu@netvigator.com
About this study
Official title: Phase 3 Study on the Use of Capsule Endoscope for Surveillance and Detection of Peptic Ulcer Rebleeding After Therapeutic Endoscopy
To investigate the adjunctive role of "Capsule Endoscope" in continuous endoscopic monitoring and early detection of recurrent ulcer bleeding after endoscopic therapy in patients presenting with bleeding peptic ulcers
Read the detailed description
Background
Acute gastrointestinal bleeding is a common medical emergency worldwide. In Hong Kong it accounts for about 5% of all admissions through the Accident and Emergency Department1. The most common cause is bleeding from a peptic ulcer.
Ulcers bleed when an artery at the base of the ulcer is eroded, Bleeding from such an eroded artery may be intermittent, as the artery may be plugged by a thrombus. Dislodgement of the clot results in rebleeding. Rebleeding has long been recognized as one of the worse prognosticators for ulcer bleeding and is associated with a 6-10 fold increase in mortality. Rebleeding is associated with a major bleed manifested by hematemesis and hypotension, indicating that a large size vessel has been eroded. Such vessels, and the clot plugging them, may be visible endoscopically and have been named "stigmata of recent haemorrhage". Such stigmata are associated with a higher risk of rebleeding. High-risk stigmata, such as active bleeding, a protuberant "visible vessel", or an adherent clot, are now used to select patients who are liable to rebleed for endoscopic therapy. In recent years, with advances in endoscopic technology and expertise, therapeutic endoscopy has taken over as the first line therapy for bleeding5. Techniques such as injection therapy, thermal coagulation and clip application have been shown to be highly effective in controlling bleeding7.
Rebleeding after endoscopic therapy
Rebleeding is the most important prognostic factor in patients with ulcer haemorrhage. It carries a 10-fold increase in mortality. Rebleeding can be predicted by hematemesis and shock on admission. Before the era of therapeutic endoscopy traditional dogma recommends early surgery to preempt another catastrophic bleed in these patients. With the advent of effective endoscopic haemostasis the place of early surgery is less clear. Indeed a trial at our center indicates that repeat endoscopic therapy can salvage 75% of rebleeding patients without compromising patient safety10.
Scheduled repeat endoscopy at 24 hour intervals have been used to detect and retreat any remaining stigmata11. Such a policy also subjects many patients to unnecessary endoscopy and treatment but has not been shown to improve outcome. Re-endoscopy at 24-hour intervals misses rebleeding that occurs in the interim, but repeated endoscopy at closer intervals is impractical. Some authors has suggested combining clinical endoscopic data in a scoring system to select patients for repeat endoscopic re-treatment, and demonstrated improved outcome in a small series. Others have used Doppler signals in arteries in the ulcer base to predict failures of endoscopic treatment.
Recognition of rebleeding - Use of wireless endoscopy
Clinical rebleeding is usually defined as vomiting of red blood, hemodynamic instability or drop in the hemoglobin level after initial stabilization. These clinical features appear only after a significant amount of blood has been lost. There is, at present, no reliable method of detecting rebleeding in a timely fashion. If there is a reliable early warning system, analogous to ECG monitoring for arrhythmia in patients who has had a myocardial infarction, we may be able to intervene in time to preempt the harmful effects of further major blood loss in a patient who has already bled from the ulcer.
Endoscopy using a pill sized (11mm x 26mm, weight ~ 4 grams) capsule endoscope was first reported by Iddan. The capsule can be swallowed and transmit images from various part of the gastrointestinal tract as the capsule traverses the gastrointestinal tract. The main indication at present is the visualization of the small intestine, especially for locating sources of bleeding that are beyond the range of gastroscopy and colonoscopy. The battery of the capsule lasts for up to 8 hours.
We aimed to use the capsule endoscope to monitor the bleeding peptic ulcer after therapeutic endoscopy in order to detect rebleeding before clinical manifestation.
- Conditions
- Bleeding Peptic Ulcer
- Being tested
- Endoscopic placement of Capsule endoscope adjacent to the peptic ulcer
- Medical subject headings
- Peptic Ulcer Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic placement of Capsule endoscope adjacent to the peptic ulcerDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bleeding Peptic UlcerStudies 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
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Enders KW Ng, MD, Principal investigator, Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00164827
- Sponsor's protocol ID
- CRE-2002-412-T
- Other IDs
- CUHK4382/03M
- Status last verified
- Sep 2005
- First submitted
- 11 Sep 2005
- Last updated
- 14 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study on the Use of Capsule Endoscope for Surveillance and Detection of Peptic Ulcer Rebleeding After Therapeutic Endoscopy
- ClinicalTrials.gov ID
- NCT00164827
- Acronym / sponsor ID
- CRE-2002-412-T
- Conditions
- Bleeding Peptic Ulcer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jan 2003
- First posted
- 14 Sep 2005 (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.
To investigate the adjunctive role of "Capsule Endoscope" in continuous endoscopic monitoring and early detection of recurrent ulcer bleeding after endoscopic therapy in patients presenting with bleeding peptic ulcers
Detailed description
Background
Acute gastrointestinal bleeding is a common medical emergency worldwide. In Hong Kong it accounts for about 5% of all admissions through the Accident and Emergency Department1. The most common cause is bleeding from a peptic ulcer.
Ulcers bleed when an artery at the base of the ulcer is eroded, Bleeding from such an eroded artery may be intermittent, as the artery may be plugged by a thrombus. Dislodgement of the clot results in rebleeding. Rebleeding has long been recognized as one of the worse prognosticators for ulcer bleeding and is associated with a 6-10 fold increase in mortality. Rebleeding is associated with a major bleed manifested by hematemesis and hypotension, indicating that a large size vessel has been eroded. Such vessels, and the clot plugging them, may be visible endoscopically and have been named "stigmata of recent haemorrhage". Such stigmata are associated with a higher risk of rebleeding. High-risk stigmata, such as active bleeding, a protuberant "visible vessel", or an adherent clot, are now used to select patients who are liable to rebleed for endoscopic therapy. In recent years, with advances in endoscopic technology and expertise, therapeutic endoscopy has taken over as the first line therapy for bleeding5. Techniques such as injection therapy, thermal coagulation and clip application have been shown to be highly effective in controlling bleeding7.
Rebleeding after endoscopic therapy
Rebleeding is the most important prognostic factor in patients with ulcer haemorrhage. It carries a 10-fold increase in mortality. Rebleeding can be predicted by hematemesis and shock on admission. Before the era of therapeutic endoscopy traditional dogma recommends early surgery to preempt another catastrophic bleed in these patients. With the advent of effective endoscopic haemostasis the place of early surgery is less clear. Indeed a trial at our center indicates that repeat endoscopic therapy can salvage 75% of rebleeding patients without compromising patient safety10.
Scheduled repeat endoscopy at 24 hour intervals have been used to detect and retreat any remaining stigmata11. Such a policy also subjects many patients to unnecessary endoscopy and treatment but has not been shown to improve outcome. Re-endoscopy at 24-hour intervals misses rebleeding that occurs in the interim, but repeated endoscopy at closer intervals is impractical. Some authors has suggested combining clinical endoscopic data in a scoring system to select patients for repeat endoscopic re-treatment, and demonstrated improved outcome in a small series. Others have used Doppler signals in arteries in the ulcer base to predict failures of endoscopic treatment.
Recognition of rebleeding - Use of wireless endoscopy
Clinical rebleeding is usually defined as vomiting of red blood, hemodynamic instability or drop in the hemoglobin level after initial stabilization. These clinical features appear only after a significant amount of blood has been lost. There is, at present, no reliable method of detecting rebleeding in a timely fashion. If there is a reliable early warning system, analogous to ECG monitoring for arrhythmia in patients who has had a myocardial infarction, we may be able to intervene in time to preempt the harmful effects of further major blood loss in a patient who has already bled from the ulcer.
Endoscopy using a pill sized (11mm x 26mm, weight ~ 4 grams) capsule endoscope was first reported by Iddan. The capsule can be swallowed and transmit images from various part of the gastrointestinal tract as the capsule traverses the gastrointestinal tract. The main indication at present is the visualization of the small intestine, especially for locating sources of bleeding that are beyond the range of gastroscopy and colonoscopy. The battery of the capsule lasts for up to 8 hours.
We aimed to use the capsule endoscope to monitor the bleeding peptic ulcer after therapeutic endoscopy in order to detect rebleeding before clinical manifestation.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with bleeding peptic ulcers; ulcer actively bleeding or with major stigmata of visible vessels ( protuberant discolorations in ulcer bases) and clots (Forrest I, IIa and IIb ulcers) seen at endoscopy performed within 24 hours of their admissions.
- Endoscopic hemostasis achieved (with defined endpoints).
- Age > 18
- Provision of an informed written consent signed by the patient.
Key exclusion criteria (7 listed)
- The present of an intercurrent ulcer complication precluding endoscopic treatment such as gastric outlet obstruction or ulcer perforation mandating surgical intervention.
- Patients with clinical suspicion of intestinal obstruction, stricture and fistula.
- Patient with cardiac pacemaker, or any implanted electromedical device.
- Age <18
- Pregnancy
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 |
|---|---|---|
| Endoscopic placement of Capsule endoscope adjacent to the peptic ulcer | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2005.
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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.
Enders KW Ng, MD principal investigator
Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bleeding Peptic Ulcer, run by Chinese University of Hong Kong at 1 site in China.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 14 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Enders KW Ng, MD (26322627, endersng@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 14 Sep 2005.