Clinical Trial: The Selection Criteria for the Second-look Endoscopy Among Patients With Bleeding Peptic Ulcers
Study Status: Terminated
Recruit Status: Unknown status
Study Type: Observational [Patient Registry]
Official Title: The Selection Criteria for Deciding Who Needs the Second-look Endoscopy Among Patients With Bleeding Peptic Ulcers
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.
Detailed Summary:
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 sele
Sponsor: National Cheng-Kung University Hospital
Current 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.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: National Cheng-Kung University Hospital
Dates:
Date Received: July 20, 2014
Date Started: August 2011
Date Completion: July 2016
Last Updated: July 20, 2014
Last Verified: July 2014
