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临床试验/NCT02840929
NCT02840929终止不适用

Effect of Second-look Endoscopy on Peptic Ulcer Rebleeding in Patients With Early Resumption of Antiplatelet Agents

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2016年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
2
试验地点
1
主要终点
Rebleeding

研究概览

简要总结

OBJECTIVES: Up to 15% of patients with peptic ulcer bleeding will develop rebleeding, mainly in those with ulcers of higher-risk stigmata (i.e. Forrest class Ia to IIb). Randomized trials show that second-look endoscopy is effective in reducing rebleeding rate. However, whether to withhold aspirin or other anti-platelet agents (for the treatment of established cardiovascular or cerebrovascular diseases) remains controversial. Studies have shown that although continuation of anti-platelet agents reduces mortality rate due to reduced cardiovascular and cerebrovascular events, there is a marginal increase in rebleeding risk.

HYPOTHESIS: We hypothesize that continuation of aspirin or other anti-platelet agents coupled with second-look endoscopy could reduce the rebleeding rate without increasing the risk of thromboembolic events in high-risk patients.

详细描述

For patients who are found to have high-risk peptic ulcers on endoscopy, they will be treated by endoscopic combination therapy including adrenaline injection and followed by either thermal coagulation or haemoclips to achieve haemostasis. Peptic ulcers of high-risk stigmata are ulcers with active bleeding, non-bleeding visible blood vessels, or adherent blood clots according to Forrest classification (Ia to IIb).

After initial haemostasis for high-risk ulcers, patients who continue to require anti-platelet agents (namely, aspirin, clopidogrel, prasugrel, or ticagrelor) for treatment or prophylaxis of cardiovascular or cerebrovascular diseases will be eligible for inclusion into study.

Eligible patients will be randomly allocated to have a scheduled second-look endoscopy 16-24 hours after initial endoscopy (i.e. the intervention group), or to receive conventional standard care (i.e. the control group). Randomization will be performed in a 1:1 ratio by computer generated random sequences.

For patients who are allocated to second-look endoscopy group, endoscopic retreatment will be performed if the ulcer shows persistence of high-risk stigmata. Retreatment again will be performed by combination of adrenaline injection follows by thermal coagulation or haemoclips. Standard conventional care will be offered to the other group of patients, in which endoscopy is indicated only in case of suspected clinical bleeding as defined in the subsequent section.

Both the intervention and control groups will receive bolus injection of proton-pump inhibitor (esomeprazole 80mg), follow by high dose infusion of 8mg/h continuously for 72 hours after initial endoscopy. Thereafter, both groups will receive oral form of proton-pump inhibitor (esomeprazole 40mg/d)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Antiplatelet for both primary and secondary prophylaxis
  • Peptic ulcers of Forrest class Ia (spurting of blood), Ib (oozing of blood), IIa (visible vessel) & IIb (adherent clot)

排除标准

  • Peptic ulcers of class IIc (pigmented ulcer base) & III (clean ulcer base)
  • Unsuccessful endoscopic hemostasis
  • Ulcer perforation
  • Gastric outlet obstruction precluding passage of scope to D2
  • Malignant ulcers
  • Proton pump inhibitor (PPI) allergy
  • Concomitant anticoagulants
  • Pregnancy

研究组 & 干预措施

Standard care group

Active Comparator

Esomeprazole infusion for three days, followed by oral esomeprazole. OGD will be offered if signs of rebleeding present

干预措施: Esomeprazole (Drug)

Second-look OGD group

Experimental

Second-look OGD within 16 to 24 hours after primary OGD, in addition to standard care (esomeprazole infusion for three days, followed by oral esomeprazole.

OGD will be offered if signs of rebleeding present)

干预措施: Second-look OGD (Procedure)

Second-look OGD group

Experimental

Second-look OGD within 16 to 24 hours after primary OGD, in addition to standard care (esomeprazole infusion for three days, followed by oral esomeprazole.

OGD will be offered if signs of rebleeding present)

干预措施: Esomeprazole (Drug)

结局指标

主要结局

Rebleeding

时间窗: 30 days

Detect difference in the rate of rebleeding within 30 days of primary esophagogastroduodenoscopy (OGD) Rebleeding is suspected clinically by the presence of fresh haematemesis, or haematochezia/melaena after a normal stool, or unstable haemodynamics with systolic blood pressure ≤ 90 mmHg or pulse ≥ 100 beats/min (after ruling out other causes of shock, e.g. cardiogenic or septic shock), or a drop in haemoglobin level by 2 g/dL or more within 24 hours despite transfusion of 2 or more units of blood during the same period. If any one of the features is present, we will perform emergency endoscopy to confirm the diagnosis of recurrent peptic ulcer bleeding by either the persistence of ulcers of high-risk stigma or fresh blood in the stomach). Rebleeding is only defined if it is confirmed by the presence of both clinical and endoscopic features.

次要结局

  • cardiovascular/cerebrovascular events(30 days)
  • all-cause mortality(30 days)
  • days of hospital stay(30 days)
  • units of packed cell transfused(30 days)
  • radiological and/or surgical interventions (as documented in Clinical Management System and medical records)(30 days)
  • gastrointestinal mortality, vascular mortality, combined gastrointestinal and vascular mortality(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

LEUNG Wai Keung

Professor

The University of Hong Kong

研究点 (1)

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