Clinical trial NCT01142180: Early Selective TAE to Severely Bleeding Peptic Ulcers After Their Initial Endoscopic Hemostasis
Official title: Early Selective Angiographic Embolization to Severely Bleeding Peptic Ulcers After Their Initial Endoscopic Hemostasis - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bleeding
Peptic Ulcer
Arterial Embolization
Keywords: Bleeding peptic ulcer
Active bleeding
Trans-arterial angiographic embolization
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: King Chulalongkorn Memorial Hospital
First posted: 2010-06-11
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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:

-

Primary outcomes:
measure: clinical re-bleeding
timeFrame: within 30 days of therapy
Secondary outcomes:
measure: death from all causes
timeFrame: within 30 days of therapy
measure: transfusion requirement
timeFrame: within 30 days of therapy
measure: hospital stay including Intensive Care Unit stay
timeFrame: within 30 days of therapy
measure: further interventions either further TAE or surgery
timeFrame: within 30 days of therapy
measure: hospital costs
timeFrame: within 30 days of therapy
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Endoscopy Centre, Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: James Y LAU, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.