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The Selection Criteria for the Second-look Endoscopy Among Patients With Bleeding Peptic Ulcers (CSE)

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ClinicalTrials.gov Identifier: NCT02197039
Recruitment Status : Unknown
Verified July 2014 by National Cheng-Kung University Hospital.
Recruitment status was:  Recruiting
First Posted : July 22, 2014
Last Update Posted : July 22, 2014
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
National Cheng-Kung University Hospital

Brief 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. These risk factors will be the selection criteria for patients who are indicated to receive second-look endoscopy.

Condition or disease Intervention/treatment
Peptic Ulcer Hemorrhage Drug: esomeprazole or pantoprazole Procedure: Endoscopic hemostasis

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 350 participants
Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 3 Days
Official Title: The Selection Criteria for Deciding Who Needs the Second-look Endoscopy Among Patients With Bleeding Peptic Ulcers
Study Start Date : August 2011
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.

Drug: esomeprazole or pantoprazole
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.
Other Name: Nexium® (AstraZeneca AB) or Pantoloc® (Takeda)

Procedure: Endoscopic hemostasis
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.

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.

Drug: esomeprazole or pantoprazole
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.
Other Name: Nexium® (AstraZeneca AB) or Pantoloc® (Takeda)

Procedure: Endoscopic hemostasis
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.




Primary Outcome Measures :
  1. 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.



Biospecimen Retention:   Samples With DNA
whole blood, serum, white cells, gastric tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02197039


Contacts
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Contact: Hsiu-Chi Cheng, MD, PhD 886-6-2353535 ext 4733 teishuki@mail.ncku.edu.tw

Locations
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Taiwan
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 704
Contact: Hsiu-Chi Cheng, MD, PhD    886-6-2353535 ext 4733    teishuki@mail.ncku.edu.tw   
Principal Investigator: Hsiu-Chi Cheng, MD, PhD         
Sponsors and Collaborators
National Cheng-Kung University Hospital
National Science Council, Taiwan
Investigators
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Study Director: Bor-Shyang Sheu, MD National Cheng-Kung University Hospital

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT02197039     History of Changes
Other Study ID Numbers: A-ER-103-112
First Posted: July 22, 2014    Key Record Dates
Last Update Posted: July 22, 2014
Last Verified: July 2014

Keywords provided by National Cheng-Kung University Hospital:
Peptic ulcer hemorrhage, second-look endoscopy

Additional relevant MeSH terms:
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Hemorrhage
Peptic Ulcer Hemorrhage
Gastrointestinal Hemorrhage
Ulcer
Peptic Ulcer
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Esomeprazole
Pantoprazole
Hemostatics
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Coagulants