Early Selective Transarterial Embolization (TAE) to Severely Bleeding Peptic Ulcers After Their Initial Endoscopic Hemostasis

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Chinese University of Hong Kong
Sponsor:
Collaborator:
King Chulalongkorn Memorial Hospital
Information provided by (Responsible Party):
James Yun-wong Lau, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01142180
First received: June 9, 2010
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Bleeding
Peptic Ulcer
Arterial Embolization
Procedure: TAE
Procedure: No TAE
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • clinical re-bleeding [ Time Frame: within 30 days of therapy ] [ Designated as safety issue: No ]

    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:
  • death from all causes [ Time Frame: within 30 days of therapy ] [ Designated as safety issue: No ]
  • transfusion requirement [ Time Frame: within 30 days of therapy ] [ Designated as safety issue: No ]
  • hospital stay including Intensive Care Unit stay [ Time Frame: within 30 days of therapy ] [ Designated as safety issue: No ]
  • further interventions either further TAE or surgery [ Time Frame: within 30 days of therapy ] [ Designated as safety issue: No ]
  • hospital costs [ Time Frame: within 30 days of therapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: January 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: No TAE

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01142180

Contacts
Contact: James Y LAU, MD +85226321411 laujyw@surgery.cuhk.edu.hk
Contact: Kim W AU, MSc +85223622640 kimau@surgery.cuhk.edu.hk

Locations
China
Endoscopy Centre, Prince of Wales Hospital Recruiting
Hong Kong, China
Contact: James Y LAU, MD    +85226321411    laujyw@surgery.cuhk.edu.hk   
Contact: Kim W AU, MSc    +85226322640    kimau@surgery.cuhk.edu.hk   
Sub-Investigator: Joseph J SUNG, MD         
Sub-Investigator: Francis K CHAN, MD         
Sub-Investigator: Junstin C WU, MD         
Sub-Investigator: Vincent W WONG, MD         
Sponsors and Collaborators
Chinese University of Hong Kong
King Chulalongkorn Memorial Hospital
Investigators
Principal Investigator: James Y LAU, MD Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: James Yun-wong Lau, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01142180     History of Changes
Other Study ID Numbers: TAE2
Study First Received: June 9, 2010
Last Updated: July 29, 2013
Health Authority: Hong Kong: Department of Health

Keywords provided by Chinese University of Hong Kong:
Bleeding peptic ulcer
Active bleeding
Trans-arterial angiographic embolization

Additional relevant MeSH terms:
Peptic Ulcer
Peptic Ulcer Hemorrhage
Hemorrhage
Ulcer
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gastrointestinal Hemorrhage
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014