Peptic Ulcer HemorrhageCSENCT02197039
The Selection Criteria for the Second-look Endoscopy Among Patients With Bleeding Peptic Ulcers
An observational study of Peptic Ulcer Hemorrhage, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this prospective study is to identify risk factors which could predict poor fading of SRH or early recurrent bleeding of peptic ulcer hemorrhage after successful endoscopic hemostasis and high-dose PPI infusion. Read more about this study
- Who is it for?
- Ages 20 to 95 years
- Conditions the study is for
- Peptic Ulcer Hemorrhage
- What is being tested?
- esomeprazole or pantoprazole and Endoscopic hemostasis
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 316 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2011to Jul 2014
- How long will I take part?
- 3 Days
- 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 20 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We developed the study with data collected in an audit of admissions for acute peptic ulcer hemorrhage at the inpatient wards of National Cheng Kung University Hospital, a tertiary health care center in Tainan, Taiwan. Patients who receive gastroscopy for melena, hematochezia, or hematemesis in whom bleeding peptic ulcers with major stigmata of recent hemorrhage are detected are consecutively enrolled.
Who may be able to join
- Bleeding peptic ulcers with major stigmata of recent hemorrhage
- All of these major SRH are treated by local injection of diluted epinephrine 1:10000 with or without combined therapy with a heater probe, argon plasma coagulation, band ligation, or hemoclip therapy
Who cannot join
- Bleeding due to tumor or cancer
- Bleeding due to the presence of a Dieulafoy lesion
- Ulcer bleeding due to mechanical factors (i.e., gastrostomy tube induction)
- Proton pump inhibitors use within one week before enrollment
- Failure to establish hemostasis under gastroscopy
- Hypersensitivity to esomeprazole, pantoprazole, or any component of the formulation
- Previously participated in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Selection Criteria for Deciding Who Needs the Second-look Endoscopy Among Patients With Bleeding Peptic Ulcers
The purpose of this prospective study is to identify risk factors which could predict poor fading of SRH or early recurrent bleeding of peptic ulcer hemorrhage after successful endoscopic hemostasis and high-dose PPI infusion. These risk factors will be the selection criteria for patients who are indicated to receive second-look endoscopy.
Read the detailed description
Peptic ulcer bleeding is a common disease, and recurrent bleeding is an independent risk factor leading to mortality. The appearance of stigmata of recent hemorrhage (SRH) indicates possible recurrence of peptic ulcer bleeding, for which the likelihood decreases over the course of 3-6 days. In addition to endoscopic evidences illustrating the SRH, patients with co-morbidities have a higher risk of recurrent bleeding.
Patients with co-morbidities have not only higher recurrent bleeding rates during the first 3 days but also higher delay recurrent bleeding after 3-day proton pump inhibitor (PPI) infusion than those without. More than 50% recurrent bleeding develops after 3-day PPI infusion among patients with end stage renal diseases. Although endoscopic treatment plus a 72-hour intravenous PPI infusion and followed by oral PPI has already been adopted as a standard treatment in peptic ulcer bleeding currently, several studies showed limited effectiveness of such treatment for high risk patients. The reasons may be because lesions of SRH were not completely faded after initial treatment including endoscopic hemostasis and intravenous PPI infusion. Thus, it is an important issue to improve such high recurrent bleeding risk for these patients.
Endoscopic treatment plus a 72-hour intravenous PPI infusion is the standard protocol for treatment of peptic ulcer bleeding. Moreover, several studies have shown that PPI treatment could decrease the presentation of SRH. However, there were insufficient data to validate the efficacy of such standard treatment to fade the SRH, especially among high risk patients. Therefore, several studies looked at the efficacy of routine second-look endoscopy, defined as scheduled repeat endoscopy after primary endoscopic hemostasis in patients at high risk of rebleeding. However, the role and the selection criteria for patients who require second-look endoscopy remains uncertain. There is a pressing need to elucidate the role of second-look endoscopy in these patients.
Hence, the purpose of this prospective study is to identify risk factors which could predict poor fading of SRH or early recurrent bleeding of peptic ulcer hemorrhage after successful endoscopic hemostasis and high-dose PPI infusion. This data will show the originality and clinical importance to identify the selection criteria for patients who are indicated to receive second-look endoscopy.
- Conditions
- Peptic Ulcer Hemorrhage
- Being tested
- esomeprazole or pantoprazole, Endoscopic hemostasis
- Keywords
- Peptic ulcer hemorrhage, second-look endoscopy
- 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.
esomeprazole or pantoprazoleDrug
Also called Nexium® (AstraZeneca AB) or Pantoloc® (Takeda)
Each enrolled patient receives an 80 mg loading dose of intravenous esomeprazole (Nexium®, AstraZeneca AB, Södertälje, Sweden) immediately after hemostasis is achieved spontaneously or by gastroscopy. Patients then receive a 3-day continuous high dose (8 mg per hour) of esomeprazole infusion. Because of concern for patient safety with certain drug-drug interactions, patients who take clopidogrel receive intravenous pantoprazole (Pantoloc®, Takeda, Singen, Germany), including an 80 mg loading dose and a 3-day continuous high-dose (8 mg/h) of infusion.
Endoscopic hemostasisProcedure or surgery
At the index gastroscopy, bleeding ulcers are checked. If the adherent clot is found over the ulcer base, it will be vigorously washed away with water jet. All of the stigmata of recent hemorrhage (SRH) are treated by one or a combination of endoscopic therapies including local injection of diluted epinephrine 1:10000, bipolar heated probe at 20 J per goal consecutively until achievement of coaptive coagulation, argon plasma coagulation, band ligation, or hemoclip therapy. The success of endoscopic hemostasis is defined as cessation of bleeding together with achievement of cavitation at the vessel after application of the heater probe.
| Study group | Role | What they receive |
|---|---|---|
| The High risk group | Each enrolled patient receives an 80 mg loading dose of intravenous esomeprazole or pantoprazole immediately after successful endoscopic hemostasis. Patients then receive a 3-day continuous high dose (8 mg per hour) of esomeprazole or pantoprazole infusion.
Patients are defined in the high risk group if they still have major stigmata of recent hemorrhage at the second-look endoscopy or have early recurrent bleeding before the schedule time for follow-up.
Recurrent bleeding is defined as: 1) continuous melena, hematochezia, or the presence of recurrent bloody aspirates through a nasogastric tube and 2) relapse of hemodynamic instability, including systolic blood pressure <90 mmHg, heart rate >120 beats per minute, or a drop in hemoglobin concentration by more than 2 g/dL. Receives: Drug: esomeprazole or pantoprazole; Procedure: Endoscopic hemostasis | |
| The control group | Each enrolled patient receives an 80 mg loading dose of intravenous esomeprazole or pantoprazole immediately after successful endoscopic hemostasis. Patients then receive a 3-day continuous high dose (8 mg per hour) of esomeprazole or pantoprazole infusion.
Patients are defined in the control group if they does not have recurrent bleeding before the schedule time for follow-up, and have only minor stigmata of hemorrhage or clean ulcer base at the second-look endoscopy.
Recurrent bleeding is defined as: 1) continuous melena, hematochezia, or the presence of recurrent bloody aspirates through a nasogastric tube and 2) relapse of hemodynamic instability, including systolic blood pressure <90 mmHg, heart rate >120 beats per minute, or a drop in hemoglobin concentration by more than 2 g/dL. Receives: Drug: esomeprazole or pantoprazole; Procedure: Endoscopic hemostasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
the fading rate of major stigmata of recent hemorrhage
At the index gastroscopy, bleeding ulcers are checked. All of the major stigmata of recent hemorrhage (SRH) are treated by one or a combination of endoscopic therapies. The success of endoscopic hemostasis is defined as cessation of bleeding together with achievement of cavitation at the vessel after application of the heater probe.
Second-look endoscopy is scheduled 48-72 hours after successful index endoscopic hemostasis and intravenous high-dose proton pump inhibitor infusion. For each patient with either suspected or active recurrent bleeding, emergent endoscopy is conducted earlier before the schedule to confirm peptic ulcer recurrent bleeding.
Possible risk factors including patient's baseline clinical, laboratory characteristics, and gastroscopic pictures are obtained at the time of admission.
Multiple logistic regression analysis is applied to assess the independent risk factors related to residual major stigmata or early recurrent bleeding of peptic ulcers.
Measured: within 3 days after the index gastroscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startAug 2011
- Primary completionJul 2014
- Study completionJul 2014
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 Peptic Ulcer HemorrhageStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 316 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Bor-Shyang Sheu, MD, Study director, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197039
- Sponsor's protocol ID
- A-ER-103-112
- Acronym
- CSE
- Status last verified
- Jul 2014
- First submitted
- 20 Jul 2014
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cheng HC, Wu CT, Chen WY, Yang EH, Chen PJ, Sheu BS. Risk factors determining the need for second-look endoscopy for peptic ulcer bleeding after endoscopic hemostasis and proton pump inhibitor infusion. Endosc Int Open. 2016 Mar;4(3):E255-62. doi: 10.1055/s-0041-111499. Epub 2016 Feb 8.
PubMed 27004241
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Selection Criteria for Deciding Who Needs the Second-look Endoscopy Among Patients With Bleeding Peptic Ulcers
- ClinicalTrials.gov ID
- NCT02197039
- Acronym / sponsor ID
- CSE / A-ER-103-112
- Conditions
- Peptic Ulcer Hemorrhage
- Keywords
- Peptic ulcer hemorrhage, second-look endoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Aug 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 22 Jul 2014 (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.
The purpose of this prospective study is to identify risk factors which could predict poor fading of SRH or early recurrent bleeding of peptic ulcer hemorrhage after successful endoscopic hemostasis and high-dose PPI infusion. These risk factors will be the selection criteria for patients who are indicated to receive second-look endoscopy.
Detailed description
Peptic ulcer bleeding is a common disease, and recurrent bleeding is an independent risk factor leading to mortality. The appearance of stigmata of recent hemorrhage (SRH) indicates possible recurrence of peptic ulcer bleeding, for which the likelihood decreases over the course of 3-6 days. In addition to endoscopic evidences illustrating the SRH, patients with co-morbidities have a higher risk of recurrent bleeding.
Patients with co-morbidities have not only higher recurrent bleeding rates during the first 3 days but also higher delay recurrent bleeding after 3-day proton pump inhibitor (PPI) infusion than those without. More than 50% recurrent bleeding develops after 3-day PPI infusion among patients with end stage renal diseases. Although endoscopic treatment plus a 72-hour intravenous PPI infusion and followed by oral PPI has already been adopted as a standard treatment in peptic ulcer bleeding currently, several studies showed limited effectiveness of such treatment for high risk patients. The reasons may be because lesions of SRH were not completely faded after initial treatment including endoscopic hemostasis and intravenous PPI infusion. Thus, it is an important issue to improve such high recurrent bleeding risk for these patients.
Endoscopic treatment plus a 72-hour intravenous PPI infusion is the standard protocol for treatment of peptic ulcer bleeding. Moreover, several studies have shown that PPI treatment could decrease the presentation of SRH. However, there were insufficient data to validate the efficacy of such standard treatment to fade the SRH, especially among high risk patients. Therefore, several studies looked at the efficacy of routine second-look endoscopy, defined as scheduled repeat endoscopy after primary endoscopic hemostasis in patients at high risk of rebleeding. However, the role and the selection criteria for patients who require second-look endoscopy remains uncertain. There is a pressing need to elucidate the role of second-look endoscopy in these patients.
Hence, the purpose of this prospective study is to identify risk factors which could predict poor fading of SRH or early recurrent bleeding of peptic ulcer hemorrhage after successful endoscopic hemostasis and high-dose PPI infusion. This data will show the originality and clinical importance to identify the selection criteria for patients who are indicated to receive second-look endoscopy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The High risk group | – | Drug: esomeprazole or pantoprazole, Procedure: Endoscopic hemostasisEach enrolled patient receives an 80 mg loading dose of intravenous esomeprazole or pantoprazole immediately after successful endoscopic hemostasis. Patients then receive a 3-day continuous high dose (8 mg per hour) of esomeprazole or pantoprazole infusion. Patients are defined in the high risk group if they still have major stigmata of recent hemorrhage at the second-look endoscopy or have early recurrent bleeding before the schedule time for follow-up. Recurrent bleeding is defined as: 1) continuous melena, hematochezia, or the presence of recurrent bloody aspirates through a nasogastric tube and 2) relapse of hemodynamic instability, including systolic blood pressure <90 mmHg, heart rate >120 beats per minute, or a drop in hemoglobin concentration by more than 2 g/dL. |
| The control group | – | Drug: esomeprazole or pantoprazole, Procedure: Endoscopic hemostasisEach enrolled patient receives an 80 mg loading dose of intravenous esomeprazole or pantoprazole immediately after successful endoscopic hemostasis. Patients then receive a 3-day continuous high dose (8 mg per hour) of esomeprazole or pantoprazole infusion. Patients are defined in the control group if they does not have recurrent bleeding before the schedule time for follow-up, and have only minor stigmata of hemorrhage or clean ulcer base at the second-look endoscopy. Recurrent bleeding is defined as: 1) continuous melena, hematochezia, or the presence of recurrent bloody aspirates through a nasogastric tube and 2) relapse of hemodynamic instability, including systolic blood pressure <90 mmHg, heart rate >120 beats per minute, or a drop in hemoglobin concentration by more than 2 g/dL. |
Who may qualify
- Ages
- 20 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We developed the study with data collected in an audit of admissions for acute peptic ulcer hemorrhage at the inpatient wards of National Cheng Kung University Hospital, a tertiary health care center in Tainan, Taiwan. Patients who receive gastroscopy for melena, hematochezia, or hematemesis in whom bleeding peptic ulcers with major stigmata of recent hemorrhage are detected are consecutively enrolled.
Key inclusion criteria (2 listed)
- Bleeding peptic ulcers with major stigmata of recent hemorrhage
- All of these major SRH are treated by local injection of diluted epinephrine 1:10000 with or without combined therapy with a heater probe, argon plasma coagulation, band ligation, or hemoclip therapy
Key exclusion criteria (7 listed)
- Bleeding due to tumor or cancer
- Bleeding due to the presence of a Dieulafoy lesion
- Ulcer bleeding due to mechanical factors (i.e., gastrostomy tube induction)
- Proton pump inhibitors use within one week before enrollment
- Failure to establish hemostasis under gastroscopy
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 |
|---|---|---|
| esomeprazole or pantoprazoleAlso: Nexium® (AstraZeneca AB) or Pantoloc® (Takeda)Each enrolled patient receives an 80 mg loading dose of intravenous esomeprazole (Nexium®, AstraZeneca AB, Södertälje, Sweden) immediately after hemostasis is achieved spontaneously or by gastroscopy. Patients then receive a 3-day continuous high dose (8 mg per hour) of esomeprazole infusion. Because of concern for patient safety with certain drug-drug interactions, patients who take clopidogrel receive intravenous pantoprazole (Pantoloc®, Takeda, Singen, Germany), including an 80 mg loading dose and a 3-day continuous high-dose (8 mg/h) of infusion. | Drug | The High risk group, The control group |
| Endoscopic hemostasisAt the index gastroscopy, bleeding ulcers are checked. If the adherent clot is found over the ulcer base, it will be vigorously washed away with water jet. All of the stigmata of recent hemorrhage (SRH) are treated by one or a combination of endoscopic therapies including local injection of diluted epinephrine 1:10000, bipolar heated probe at 20 J per goal consecutively until achievement of coaptive coagulation, argon plasma coagulation, band ligation, or hemoclip therapy. The success of endoscopic hemostasis is defined as cessation of bleeding together with achievement of cavitation at the vessel after application of the heater probe. | Procedure or surgery | The High risk group, The control group |
Primary outcome
the fading rate of major stigmata of recent hemorrhage
Time frame: within 3 days after the index gastroscopy
At the index gastroscopy, bleeding ulcers are checked. All of the major stigmata of recent hemorrhage (SRH) are treated by one or a combination of endoscopic therapies. The success of endoscopic hemostasis is defined as cessation of bleeding together with achievement of cavitation at the vessel after application of the heater probe. Second-look endoscopy is scheduled 48-72 hours after successful index endoscopic hemostasis and intravenous high-dose proton pump inhibitor infusion. For each patient with either suspected or active recurrent bleeding, emergent endoscopy is conducted earlier before the schedule to confirm peptic ulcer recurrent bleeding. Possible risk factors including patient's baseline clinical, laboratory characteristics, and gastroscopic pictures are obtained at the time of admission. Multiple logistic regression analysis is applied to assess the independent risk factors related to residual major stigmata or early recurrent bleeding of peptic ulcers.
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 26 Jul 2022.
- Derived from this study: PubMed 27004241Cheng HC, Wu CT, Chen WY, Yang EH, Chen PJ, Sheu BS. Risk factors determining the need for second-look endoscopy for peptic ulcer bleeding after endoscopic hemostasis and proton pump inhibitor infusion. Endosc Int Open. 2016 Mar;4(3):E255-62. doi: 10.1055/s-0041-111499. Epub 2016 Feb 8.
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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.
Bor-Shyang Sheu, MD study director
National Cheng-Kung University Hospital
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 Peptic Ulcer Hemorrhage, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 2 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: finished, as of the sponsor's last update on 26 Jul 2022. 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 Taiwan. 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?
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 fading rate of major stigmata of recent hemorrhage (time frame: within 3 days after the index gastroscopy). 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 NCT02197039, 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 26 Jul 2022.