- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02352155
Second-look Endoscopy in High Risk Patients After Endoscopic Hemostasis to Their Bleeding Peptic Ulcers Improves Their Outcomes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Hospitalization for bleeding peptic ulcers has declined over past decades [1]. Bleeding from peptic ulcers however remains the commonest diagnosis in those who present with acute upper gastrointestinal bleeding (AUGIB). The incidence has been around 60-80/100,000 population. Endoscopic hemostatic therapy is the first treatment to those with active bleeding and major stigmata of bleeding. Endoscopic therapy stops bleeding and reduces rate of further bleeding, requirement for surgery and importantly deaths [2]. Adjunctive intravenous infusion of a high dose proton pump inhibitor (PPI) further reduces rebleeding. In a multicentre international placebo controlled trial that involved 767 patients with bleeding peptic ulcers, a PPI infusion reduced the rate of further bleeding (10.3 to 5.9% at 72 hour, P=0.026) In a subgroup analysis of a Cochrane meta-analysis over use of PPI in bleeding peptic ulcers, the adjunctive use of PPI in those who underwent endoscopic hemostatic treatment, when compared to those without PPI therapy, was associated with a reduction in deaths (17/954 vs. 32/ 969; OR 0.54; 95%CI 0.3-0.96) [ 4 ] . Despite of aggressive endoscopic therapy and maximal acid suppression using a PPI infusion, further bleeding occurs in around 8% of patients. Further bleeding is the single most important adverse prognostic factor and is associated with a 4 fold increase in mortality. From a National United Kingdom Audit on the management of patients with AUGIB, those who needed surgery for further bleeding and failed endoscopic control had a mortality of 28% [ 5 ]. In addition to initial control of bleeding with endoscopic therapy, the prevention of further bleeding is an important objective.
The use of routine second look endoscopy with re-treatment has been evaluated in several clinical trials. A recent meta-analysis [ 6 ] of these clinical trials concluded that the use of routine second look endoscopy confers a modest reduction in rate of further bleeding. In this pooled analysis of 8 trials and 938 patients, the absolute risk reduction was 6.8% (16.5 to 9.7%). The number to treat to prevent one episode of recurrent bleeding was 15. Only one of these trials used high dose PPI infusion and epinephrine injection alone was used as endoscopic treatment. The use of epinephrine injection is no longer considered an optimal treatment. A second modality should be added to induce vessel thrombosis [ 7 ]. Clinical practice in the reported trials was considered not contemporary. In the modern practice of combination endoscopic treatment and maximal acid suppression, the use of routine second look endoscopy cannot be recommended as the NNT to prevent further bleeding would likely be higher. A policy of routine second look endoscopy is generally not recommended as suggested by an International Consensus Group [ 8 ].
Second look endoscopy in those at high risk of further bleeding is however a logical approach. The NNT to prevent further bleeding diminishes as risk of further bleeding increases. For instance, an ulcer > 2 cm in size with Forrest I or Forrest II a bleeding would be associated with a re-bleeding risk of 15-20% even with high dose PPI infusion. Saeed et al. reported a study consisted of a small number of patients (n=40) and showed that endoscopic re-treatment in selected high risk patients based on a Baylor College score led to significant reduction in further bleeding (0 vs. 24%). This selective approach warrants investigation and could represent a dominant strategy in addition to high dose PPI infusion as a pre-emptive management of patients at high risk of further bleeding. A prerequisite to this approach is a risk score that predicts further bleeding in patients after endoscopic hemostasis and PPI infusion. This risk score needs to be derived from a large cohort of patients after uniform endoscopic treatment and acid suppression. The score will have to be validated in a prospective cohort of patients with bleeding peptic ulcers again after the same aggressive treatment. Furthermore, a randomized controlled trial on the use of second look endoscopy in high risk patients as identified by this risk score is required.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age >=18
- Informed consent obtained
- Successful endoscopic hemostasis
- Risk Score >= 5
Exclusion Criteria:
- Age < 18
- Pregnancy
- Incomplete endoscopic haemostasis -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Second look endoscopy
Second look endoscopy in the following morning with re-treatment to the bleeding vessel using epinephrine injection or heater probe or hemoclips
|
Elective Second look endoscopy in the following morning with re-treatment to the bleeding vessel using epinephrine injection or heater probe or hemoclips
|
Placebo Comparator: observation only
NO second look endoscopy (Observation)
|
Observation for rebleeding, unscheduled endoscopy only when rebleeding criteria fulfilled
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
clinical significant bleeding
Time Frame: 30 days
|
1) fresh hematemesis or melena and 2) hypotensive with systolic blood pressure less than or equal to 90 mmHg and pulse rate of greater than or equal to 110 per minute and/ or a drop of haemoglobin of >2g/dl in 24 hours and a hematocrit of 0.24.
Further bleeding has to be documented by endoscopic findings or fresh blood in the stomach together with a bleeding or non-bleeding visible vessel.
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
additional intervention for further bleeding
Time Frame: 30 days
|
additional intervention for further bleeding (surgery or angiographic intervention),
|
30 days
|
blood transfusion
Time Frame: 30 days
|
no. of participants with blood transfusion; median blood transfusion
|
30 days
|
hospitalisation,
Time Frame: 30 days
|
hospitalisation (including ICU stay)
|
30 days
|
treatment related complications
Time Frame: 30 days
|
no. of participants with ulcer perforation
|
30 days
|
deaths from all causes
Time Frame: 30 days
|
mortality, (related or not related to treatment ) cause of death
|
30 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: James Y LAU, Prof, CUHK
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Gastrointestinal Diseases
- Stomach Diseases
- Intestinal Diseases
- Duodenal Diseases
- Gastrointestinal Hemorrhage
- Ulcer
- Hemorrhage
- Peptic Ulcer
- Peptic Ulcer Hemorrhage
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Epinephrine
Other Study ID Numbers
- SLOGD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Ulcer Bleeding
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.UnknownBleeding Gastric Ulcer | Bleeding Duodenal UlcerChina
-
Chinese University of Hong KongCompleted
-
Chinese University of Hong KongCompletedGastrointestinal Bleeding | Bleeding Peptic Ulcer | Active BleedingChina
-
Livzon Pharmaceutical Group Inc.Completed
-
Chinese University of Hong KongNational Taiwan University Hospital; Beijing Friendship HospitalRecruitingAspirin | GastroIntestinal BleedingHong Kong
-
Kaohsiung Veterans General Hospital.Completed
-
AstraZenecaCompleted
-
Chinese University of Hong KongNational Taiwan University Hospital; Okayama University; Tokyo University; Tsuyama... and other collaboratorsCompletedBleeding Peptic UlcerChina
-
Azienda USL ModenaRecruiting
Clinical Trials on epinephrine injection or heater probe or hemoclips
-
Xiaolin Chen, MDRecruitingSubarachnoid Hemorrhage, AneurysmalChina
-
Grand Medical Pty Ltd.Grand Pharmaceutical (China) Co., Ltd.RecruitingAcute Respiratory Distress SyndromeChina
-
Changhua Christian HospitalTaipei Medical University Hospital; Dalin Tzu Chi General HospitalWithdrawnPeptic Ulcer BleedingTaiwan
-
Johannes VermehrenCompleted
-
Shanghai Hengrui Pharmaceutical Co., Ltd.Not yet recruiting
-
Guangdong Hengrui Pharmaceutical Co., LtdEnrolling by invitationKidney TransplantationChina
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Not yet recruiting
-
Rutgers UniversityCompletedTrigger Point Pain, Myofascial | Nerve Block | Myofascial Pain - Dysfunction Syndrome of TMJ
-
Vivozon, Inc.Completed
-
Vivozon, Inc.CompletedHealthyKorea, Republic of