Bleeding Peptic Ulcer Clinical Trial
— OTSC-LBGDUOfficial title:
The Use of Over-the-scope-clips in Large Bleeding Gastro-duodenal Ulcers; a Randomized Comparison to Standard Endoscopic Hemostatic Methods
In managing bleeding gastroduodenal ulcers, endoscopic control of bleeding is the first line treatment-further bleeding after endoscopic hemostasis is associated with a 3-fold increase in mortality. Large ulcer size (> 20 mm) predicts further bleeding. These ulcers erode into arteries of significant size (>2 mm) from either the gastro-duodenal or left gastric arterial complexes. An over-the-scope clip is an endoscopic clamp device with a high tensile strength. It can compress sizeable arteries, and firmly anchor onto the ulcer base avoiding recurrent bleeding from clip dislodgement. It therefore offers secure and durable hemostasis. In the proposed randomized controlled trial, the investigators hypothesize that after initial endoscopic control of bleeding from large gastro-duodenal ulcers (20 mm in size or more), adding an OTSC can prevent recurrent bleeding and improve patients' outcomes. Investigators enroll patients with bleeding from large ulcers as defined. After initial endoscopic control of bleeding using injection with diluted epinephrine, these patients are randomized, during endoscopy, to receive standard treatment (thermo-coagulation or hemo-clips) or an added OTSC. The primary endpoint is recurrent bleeding over 30 days confirmed on endoscopy. Secondary endpoints include the need for rescue treatment; endoscopic, angiographic embolization or surgery, red blood cell (RBC) transfusion, hospitalization, and bleeding related and all-cause mortality.
Status | Not yet recruiting |
Enrollment | 136 |
Est. completion date | December 1, 2027 |
Est. primary completion date | June 1, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 111 Years |
Eligibility | Inclusion Criteria: - patients admitted with acute upper gastrointestinal bleeding (melena, hematemesis, or decrease in hemoglobin level with or without hypotension). - large gastro-duodenal ulcers (20 mm in size or more) - active bleeding (pulsatile or Forrest Ia bleeding, oozing from a visible vessel, or Forrest Ib bleeding) or a nonbleeding visible vessel (Forrest IIa lesion). Clots overlying bleeding lesions are injected with diluted epinephrine and then irrigated or elevated using a cheese-wiring technique. If a vessel is then unveiled, we can proceed with randomization. Exclusion Criteria: - patients with esophagogastric varices - pregnant or lactating women - patients who cannot provide written consent - moribund from their co-morbid illnesses and are not considered for active treatment. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Chinese University of Hong Kong | Beijing Friendship Hospital, King Chulalongkorn Memorial Hospital, Nanfang Hospital, Southern Medical University, The First Affiliated Hospital of Nanchang University, West China Hospital |
Barkun AN, Almadi M, Kuipers EJ, Laine L, Sung J, Tse F, Leontiadis GI, Abraham NS, Calvet X, Chan FKL, Douketis J, Enns R, Gralnek IM, Jairath V, Jensen D, Lau J, Lip GYH, Loffroy R, Maluf-Filho F, Meltzer AC, Reddy N, Saltzman JR, Marshall JK, Bardou M. — View Citation
Casagrande JT, Pike MC. An improved approximate formula for calculating sample sizes for comparing two binomial distributions. Biometrics. 1978 Sep;34(3):483-6. No abstract available. — View Citation
Chan S, Pittayanon R, Wang HP, Chen JH, Teoh AY, Kuo YT, Tang RS, Yip HC, Ng SKK, Wong S, Mak JWY, Chan H, Lau L, Lui RN, Wong M, Rerknimitr R, Ng EK, Chiu PWY. Use of over-the-scope clip (OTSC) versus standard therapy for the prevention of rebleeding in — View Citation
Elmunzer BJ, Young SD, Inadomi JM, Schoenfeld P, Laine L. Systematic review of the predictors of recurrent hemorrhage after endoscopic hemostatic therapy for bleeding peptic ulcers. Am J Gastroenterol. 2008 Oct;103(10):2625-32; quiz 2633. doi: 10.1111/j.1 — View Citation
Hearnshaw SA, Logan RF, Lowe D, Travis SP, Murphy MF, Palmer KR. Acute upper gastrointestinal bleeding in the UK: patient characteristics, diagnoses and outcomes in the 2007 UK audit. Gut. 2011 Oct;60(10):1327-35. doi: 10.1136/gut.2010.228437. Epub 2011 A — View Citation
Jensen DM, Kovacs T, Ghassemi KA, Kaneshiro M, Gornbein J. Randomized Controlled Trial of Over-the-Scope Clip as Initial Treatment of Severe Nonvariceal Upper Gastrointestinal Bleeding. Clin Gastroenterol Hepatol. 2021 Nov;19(11):2315-2323.e2. doi: 10.101 — View Citation
Lau JYW, Li R, Tan CH, Sun XJ, Song HJ, Li L, Ji F, Wang BJ, Shi DT, Leung WK, Hartley I, Moss A, Yu KYY, Suen BY, Li P, Chan FKL. Comparison of Over-the-Scope Clips to Standard Endoscopic Treatment as the Initial Treatment in Patients With Bleeding From — View 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 — View Citation
Meier B, Wannhoff A, Denzer U, Stathopoulos P, Schumacher B, Albers D, Hoffmeister A, Feisthammel J, Walter B, Meining A, Wedi E, Zachaus M, Pickartz T, Kullmer A, Schmidt A, Caca K. Over-the-scope-clips versus standard treatment in high-risk patients wit — View Citation
Schmidt A, Golder S, Goetz M, Meining A, Lau J, von Delius S, Escher M, Hoffmann A, Wiest R, Messmann H, Kratt T, Walter B, Bettinger D, Caca K. Over-the-Scope Clips Are More Effective Than Standard Endoscopic Therapy for Patients With Recurrent Bleeding — View Citation
Vergara M, Bennett C, Calvet X, Gisbert JP. Epinephrine injection versus epinephrine injection and a second endoscopic method in high-risk bleeding ulcers. Cochrane Database Syst Rev. 2014 Oct 13;2014(10):CD005584. doi: 10.1002/14651858.CD005584.pub3. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | red cell transfusion | amount of total blood transfusion | 30 days | |
Other | number of days in the hospital | hospital stay | 30 days | |
Other | number of days in intensive care unit (ICU) | ICU stay | 30 days | |
Other | rate of bleeding-related or all-cause deaths | bleeding-related or all-cause mortality | 30 days | |
Primary | bleeding free probability in 30 days after randomization | further bleeding defined by the composite of failure to control bleeding after assigned endoscopic treatment and recurrent bleeding. | 30 days | |
Secondary | failure to control bleeding with assigned endoscopic treatment and recurrent bleeding after initial hemostasis | failure to control bleeding during the first endoscopy was defined as persistent or active bleeding after the attempted application of assigned endoscopic treatment. Recurrent bleeding was defined by fresh hematemesis, fresh melena, or hematochezia with hemodynamic instability (systolic blood pressure <90 mm Hg, heart rate >110 beats/min), and/or decrease in hemoglobin level greater than 20 g/L in 24 hours after transfusion to around 80 g/L. Patients who fulfill the clinical criteria of recurrent bleeding undergo urgent endoscopy. Recurrent bleeding requires endoscopic confirmation showing fresh blood in the gastroduodenal tract and active bleeding from a previously treated ulcer. | 30 days | |
Secondary | number of participants using angiographic treatment | angiogram with embolization to bleeding vessel if primary failure or rebleeding | 30 days | |
Secondary | number of participants using surgical treatment | surgical treatment if primary failure or rebleeding | 30 days | |
Secondary | second endoscopic attempts at hemostasis | attempts at hemostasis if primary failure or rebleeding. | 30 days |
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