Clinical trial NCT02197039: The Selection Criteria for the Second-look Endoscopy Among Patients With Bleeding Peptic Ulcers
Official title: The Selection Criteria for Deciding Who Needs the Second-look Endoscopy Among Patients With Bleeding Peptic Ulcers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peptic Ulcer Hemorrhage
Keywords: Peptic ulcer hemorrhage, second-look endoscopy
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2014-07-22
Enrollment: 316
Sex: ALL
Minimum age (years): 20
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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.

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 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.

Eligibility 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

Primary outcomes:
measure: the fading rate of major stigmata of recent hemorrhage
timeFrame: within 3 days after the index gastroscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
affiliation: National Cheng-Kung University Hospital
name: Bor-Shyang Sheu, MD
role: STUDY_DIRECTOR
References:
citation: 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.