The Selection Criteria for the Second-look Endoscopy Among Patients With Bleeding Peptic Ulcers
Condition: Peptic Ulcer Hemorrhage
MeSH terms: Peptic Ulcer; Peptic Ulcer Hemorrhage; Ulcer; Hemorrhage
Study type: Observational [Patient Registry]

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.
    

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.
    

Intervention name(s): esomeprazole or pantoprazole; Endoscopic hemostasis
Intervention type(s): Drug; Procedure
Intervention description(s): 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.; 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.
Other intervention name(s): Nexium® (AstraZeneca AB) or Pantoloc® (Takeda)
Intervention MeSH terms: Esomeprazole; Pantoprazole; Hemostatics
Observational model: Case-Control
Time perspective: Prospective
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.
      
Biospecimen description: 
      whole blood, serum, white cells, gastric tissue
    
Keywords: Peptic ulcer hemorrhage, second-look endoscopy