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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Enders KW Ng, MD contact

26322627

endersng@surgery.cuhk.edu.hk

Philip WY Chiu, MBChB, FRCSEd contact

26322627

pwychiu@netvigator.com

China1 site, 1 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

    Recruiting

Other trials in China

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.

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.

  1. First posted14 Sep 2005 (estimated)
  2. Study startJan 2003

Resources

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
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

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.

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