- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00164827
Surveillance of Bleeding Peptic Ulcer Using Wireless Capsule Endoscopy
Phase 3 Study on the Use of Capsule Endoscope for Surveillance and Detection of Peptic Ulcer Rebleeding After Therapeutic Endoscopy
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment
Contacts and Locations
Study Contact
- Name: Enders KW Ng, MD
- Phone Number: 26322627
- Email: endersng@surgery.cuhk.edu.hk
Study Contact Backup
- Name: Philip WY Chiu, MBChB, FRCSEd
- Phone Number: 26322627
- Email: pwychiu@netvigator.com
Study Locations
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Hong Kong, China
- Recruiting
- Endoscopy Center, Prince of Wales Hospital
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Contact:
- Enders KW Ng, MD
- Phone Number: 26322627
- Email: endersng@surgery.cuhk.edu.hk
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Contact:
- Philip WY Chiu, MBChB,FRCSEd
- Phone Number: 26322627
- Email: pwychiu@netvigator.com
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Sub-Investigator:
- Philip WY Chiu, MBChB, FRCSEd
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Defined Population
- Time Perspectives: Prospective
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Enders KW Ng, MD, Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRE-2002-412-T
- CUHK4382/03M
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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