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Early Selective TAE to Severely Bleeding Peptic Ulcers After Their Initial Endoscopic Hemostasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01142180
Recruitment Status : Completed
First Posted : June 11, 2010
Last Update Posted : July 18, 2018
King Chulalongkorn Memorial Hospital
Information provided by (Responsible Party):
James Yun-wong Lau, Chinese University of Hong Kong

Brief Summary:
The aim of this study is to determine if early angiographic embolization can forestall recurrent bleeding in selected high risk ulcers after their initial endoscopic control; to validate prospectively the investigators proposed in selecting high risk ulcers for recurrent bleeding in spite of maximal endoscopic control and profound acid suppression using high dose intravenous infusion of proton pump inhibitor; to characterize the nature of bleeding arteries in severely bleeding peptic ulcers and determine the efficacy of angiographic embolization in the prevention of recurrent bleeding and to establish safety profile of angiographic embolization as an early elective treatment to bleeding peptic ulcers.

Condition or disease Intervention/treatment Phase
Bleeding Peptic Ulcer Arterial Embolization Procedure: TAE Procedure: No TAE Not Applicable

Detailed Description:
Endoscopic therapy is now the treatment of choice in patients with actively bleeding peptic ulcers and ulcers with non-bleeding visible vessels. Following endoscopic control of bleeding, we showed that the use of a high dose intravenous infusion of proton pump inhibitor (PPI) for 72 hours further reduced rate of recurrent bleeding [Lau NEJM 2000]. Recurrent bleeding still occurs in 8 to 10 percent of patients who receive the above treatment regime. The associated mortality following a rebleed is 4-10 fold higher when compared to those without recurrent bleeding. In a logistic regression model involving 1144 patients after successful endoscopic thermocoagulation to their bleeding peptic ulcers, we demonstrated that several factors independently predicted recurrent bleeding. They included hypotension, hemoglobin <10g/dl, fresh blood in the stomach, ulcer size > 2cm and active bleeding during endoscopy [Wong Gut 2003]. When we applied this model in a cohort of 945 patients who underwent endoscopic control of bleeding to their ulcers and adjunctive use of high dose intravenous PPI, 275 belonged to the high risk group. Of them, rebleeding leading to surgery or death occurred in 46 patients (16.7%)[Chiu DDW 2007]. Endoscopic treatment to bleeding peptic ulcers has its own limit. In an ex vivo bleeding model using canine mesenteric arteries, endoscopic thermocoagulation could only consistently seal arteries up to 2 mm in size [Johnson Gastro 1987]. Trans-arterial angiography allows clinicians to study and characterize bleeding arteries underneath peptic ulcers. In ulcers that erode into major arteries such as the gastro-duodenal artery complex and branches from left gastric artery, angiography complements endoscopic therapy in the form of selective coiling of the bleeding artery. Trans-arterial angiographic coiling can provide definitive control of bleeding from larger arteries i.e. > 2 mm in size. In cohort studies, trans-arterial angiographic coiling has been shown to compare favorably to surgery, and is less invasive in the control of severe bleeding in peptic

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 258 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Selective Angiographic Embolization to Severely Bleeding Peptic Ulcers After Their Initial Endoscopic Hemostasis - a Randomized Controlled Trial
Actual Study Start Date : January 2010
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: TAE group
Patients will be undergone TAE after endoscopic hemostasis.
Procedure: TAE
The procedure will be performed within 12 hours of endoscopic therapy. This is usually performed under conscious sedation
Other Name: Transarterial embolization

Active Comparator: No TAE group
No TAE procedure will be performed after endoscopic treatment.
Procedure: No TAE
No TAE procedure will be performed after endoscopic treatment

Primary Outcome Measures :
  1. clinical re-bleeding [ Time Frame: within 30 days of therapy ]

    Clinical rebleeding is defined by fresh hematemesis, fresh melena or hematochezia and signs of hypovolemic shock (systolic blood pressure of <90mmHg and pulse rate >110 per minute) and a drop in hemoglobin of > 2 g/dl per 24 hours despite adequate transfusion.

    Rebleeding will be confirmed by an immediate endoscopy showing fresh blood in stomach or active bleeding from a previously seen ulcer. A clinical rebleeding will be independently reviewed by an adjudication panel.

Secondary Outcome Measures :
  1. death from all causes [ Time Frame: within 30 days of therapy ]
    death from all causes

  2. transfusion requirement [ Time Frame: within 30 days of therapy ]
    transfusion requirement

  3. hospital stay including Intensive Care Unit stay [ Time Frame: within 30 days of therapy ]
    hospital stay including Intensive Care Unit stay

  4. further interventions either further TAE or surgery [ Time Frame: within 30 days of therapy ]
    further interventions either further TAE or surgery

  5. hospital costs [ Time Frame: within 30 days of therapy ]
    hospital costs

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Actively bleeding peptic ulcers (Forrest I), NBVV or Forrest IIa ulcer,
  • Successful endoscopic hemostasis by combination treatment of injected epinephrine followed by either 3.2mm heat probe 30J (4 continuous pulses) or hemo-clipping (at least 2 clips) And one of the followings
  • Spurting hemorrhage during endoscopy;
  • Ulcer >= 2 cm is determined by an opened biopsy forceps;
  • Hb on admission of < 9 g/dl; or
  • Hypotension prior to endoscopy defined by SBP of <90 mmHg AND HR of >110 bmp

Exclusion Criteria:


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 identifier (NCT number): NCT01142180

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Endoscopy Centre, Prince of Wales Hospital
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
King Chulalongkorn Memorial Hospital
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Principal Investigator: James Y LAU, MD Chinese University of Hong Kong
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: James Yun-wong Lau, Professor, Chinese University of Hong Kong Identifier: NCT01142180    
Other Study ID Numbers: TAE2
First Posted: June 11, 2010    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Keywords provided by James Yun-wong Lau, Chinese University of Hong Kong:
Bleeding peptic ulcer
Active bleeding
Trans-arterial angiographic embolization
Additional relevant MeSH terms:
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Peptic Ulcer
Peptic Ulcer Hemorrhage
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gastrointestinal Hemorrhage