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

NCT ID: NCT01142180

Last Updated: 2018-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 258 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2014-07-31

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.

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

Conditions

Bleeding; Peptic Ulcer; Arterial Embolization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TAE group

Patients will be undergone TAE after endoscopic hemostasis.

Group Type: ACTIVE_COMPARATOR

TAE

Intervention Type: PROCEDURE

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

No TAE group

No TAE procedure will be performed after endoscopic treatment.

Group Type: ACTIVE_COMPARATOR

No TAE

Intervention Type: PROCEDURE

No TAE procedure will be performed after endoscopic treatment

Interventions

TAE

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

Intervention Type: PROCEDURE

No TAE

No TAE procedure will be performed after endoscopic treatment

Intervention Type: PROCEDURE

Other Intervention Names

Transarterial embolization

Eligibility 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

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Chulalongkorn Memorial Hospital

OTHER

Sponsor Role: collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

James Yun-wong Lau

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James Y LAU, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Endoscopy Centre, Prince of Wales Hospital

Hong Kong, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 29802172 (View on PubMed)

Other Identifiers

TAE2

Identifier Type: -

Identifier Source: org_study_id