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

NCT02197039 | Completed DMC

• 1 other identifier: A-ER-103-112
• Study Type: observational
• Target: 316
• Locations: 1 country
• Sites: 1

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.

Conditions

Peptic Ulcer Hemorrhage

Keywords

Peptic ulcer hemorrhage, second-look endoscopy

Outcome Measures

Primary Outcomes (1)

• 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.

  within 3 days after the index gastroscopy

Study Arms (2)

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; 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.

Drug: esomeprazole or pantoprazole; Procedure: Endoscopic hemostasis

Interventions

esomeprazole or pantoprazole DRUG

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.

Also known as: Nexium® (AstraZeneca AB) or Pantoloc® (Takeda)

The High risk group; The control group

Endoscopic hemostasis PROCEDURE

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 High risk group; The control group

Eligibility Criteria

• Age: 20 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 27004241 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, white cells, gastric tissue

MeSH Terms

Conditions

Peptic Ulcer Hemorrhage

Interventions

Esomeprazole; Pantoprazole; Hemostasis, Endoscopic

Condition Hierarchy (Ancestors)

Gastrointestinal Hemorrhage; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hemostatic Techniques; Therapeutics

Study Officials

• Bor-Shyang Sheu, MD

  National Cheng-Kung University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2014
• First Posted: July 22, 2014
• Study Start: August 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 26, 2022

Record last verified: 2014-07

Locations

TW (1)