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

NCT01142180 | Completed DMC

• 1 other identifier: TAE2
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

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.

Conditions

Bleeding; Peptic Ulcer; Arterial Embolization

Keywords

Bleeding peptic ulcer; Active bleeding; Trans-arterial angiographic embolization

Outcome Measures

Primary Outcomes (1)

• clinical re-bleeding

  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.

  within 30 days of therapy

Secondary Outcomes (5)

• death from all causes

  within 30 days of therapy

• transfusion requirement

  within 30 days of therapy

• hospital stay including Intensive Care Unit stay

  within 30 days of therapy

• further interventions either further TAE or surgery

  within 30 days of therapy

• hospital costs

  within 30 days of therapy

Study Arms (2)

TAE group

ACTIVE COMPARATOR

Patients will be undergone TAE after endoscopic hemostasis.

Procedure: TAE

No TAE group

ACTIVE COMPARATOR

No TAE procedure will be performed after endoscopic treatment.

Procedure: No TAE

Interventions

TAE PROCEDURE

The procedure will be performed within 12 hours of endoscopic therapy. This is usually performed under conscious sedation

Also known as: Transarterial embolization

TAE group

No TAE PROCEDURE

No TAE procedure will be performed after endoscopic treatment

No TAE group

Eligibility Criteria

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

You may qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• King Chulalongkorn Memorial Hospital: collaborator

Study Sites (1)

Endoscopy Centre, Prince of Wales Hospital

Hong Kong, China

Location

Related Publications (1)

• Lau JYW, Pittayanon R, Wong KT, Pinjaroen N, Chiu PWY, Rerknimitr R, Holster IL, Kuipers EJ, Wu KC, Au KWL, Chan FKL, Sung JJY. Prophylactic angiographic embolisation after endoscopic control of bleeding to high-risk peptic ulcers: a randomised controlled trial. Gut. 2019 May;68(5):796-803. doi: 10.1136/gutjnl-2018-316074. Epub 2018 May 25.

  PMID: 29802172 DERIVED

MeSH Terms

Conditions

Hemorrhage; Peptic Ulcer; Peptic Ulcer Hemorrhage

Condition Hierarchy (Ancestors)

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

Study Officials

• James Y LAU, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 9, 2010
• First Posted: June 11, 2010
• Study Start: January 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 18, 2018

Record last verified: 2018-07

Locations

CN (1)