Feasibility and Safety Assessment of Endoscopic Treatment of Esophagogastric Variceal Bleeding in Cirrhosis on the Day Unit: a Single-centre, Prospective-historical Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 330
- 主要终点
- Variceal rebleeding rate at 1-year follow-up after enrollment
研究概览
简要总结
The goal of this observational study is to learn about the feasibility and safety evaluation of endoscopic treatment of esophagogastric varices in cirrhosis on the day-care ward. The main question it aims to answer is:
Is inpatient endoscopic treatment on day wards also feasible and safe for patients with esophagogastric variceal bleeding in cirrhosis when compared to inpatient endoscopy on a general ward? Participants undergoing inpatient endoscopic treatment for cirrhotic esophagogastric variceal bleeding on day wards and general wards will answer online survey questions about their postoperative period over a 1-year period.
详细描述
Our project team found that for patients with varicose veins treated with re-endoscopy during sequential treatment, day ward treatment can also achieve the goal of eradicating varicose veins, reducing bleeding, and shortening the number of days in the hospital, reducing hospitalization costs, and increasing the satisfaction of the patient's visit. This study was a single-center, prospective-historical controlled study that prospectively included study participants who underwent reendoscopic treatment of cirrhotic esophagogastric varices who presented to the gastroenterology day unit of our hospital from May 2025 to December 2028 and were followed up until the death of the study participant or the end of the study, with a follow-up period of 1 year. Retrospectively included study participants who underwent reendoscopic treatment for cirrhotic esophagogastric varices who presented to the gastroenterology department of our hospital between October 2023 and October 2024, screened study participants as controls according to propensity score matching and a 1:1 ratio, and followed prospectively until the death of the study participants or the end of the study, with a follow-up period of 1 year. The key scientific question of the study was to assess whether re-endoscopic treatment of bleeding esophagogastric varices in cirrhosis on day wards is feasible and safe. The objective of the study was to assess the feasibility and safety of reendoscopic treatment of cirrhotic esophagogastric variceal bleeding on day wards.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18-75 years;
- •diagnosis of cirrhosis and portal hypertension by clinical manifestations, laboratory tests, imaging tests and histologic examinations;
- •gastroscopic grading of esophagogastric varices as moderate or severe;
- •no ruptured esophagogastric varices bleeding in the last 5 days;
- •endoscopic treatment of esophagogastric varices during hospitalization.
排除标准
- •first endoscopic treatment of esophagogastric varices;
- •this is an acute esophagogastric variceal rupture and bleeding;
- •previous TIPS or liver transplantation;
- •isolated fundal varices or ectopic varices;
- •primary hepatocellular carcinoma or acute or chronic hepatic failure, Child-pugh class C, hepatic encephalopathy stage 2 or higher;
- •spontaneous abnormally large shunts, uncontrolled infections and sepsis, uncontrolled hypertension;
- •combined cardiac, pulmonary, cerebral, renal and other serious complications or other reasons for not being able to tolerate the examination;
- •pregnant women and lactating women;
- •failure to sign the informed consent or refusal to participate.
结局指标
主要结局
Variceal rebleeding rate at 1-year follow-up after enrollment
时间窗: 1 years
Rebleeding was defined as the development of black stool or vomited blood after endoscopic treatment in study participants, which was confirmed by endoscopy to be caused by bleeding from esophagogastric varices or to exclude other lesions that could have caused the bleeding. Rebleeding included very early rebleeding and early rebleeding, with rebleeding occurring within 5 days of successful hemostasis with endoscopic treatment defined as very early rebleeding, rebleeding occurring between 5 and 42 days after endoscopic treatment defined as early rebleeding, and rebleeding within 4 hours of endoscopic treatment defined as treatment failure. Once rebleeding occurs, study participants will be treated immediately with either pharmacologic hemostasis or reendoscopic hemostasis.
次要结局
- Mortality Rate Within 1 Year of Follow-Up After Enrollment(1 years)
- Incidence of Overt Hepatic Encephalopathy (HE) Within 1 Year of Follow-Up After Enrollment(1 years)
- Hospitalization Duration(1 years)
- Hospitalization Cost(1 years)
- Varicose vein recurrence rate within 1 year of follow-up after enrollment(1 years)
研究者
Yanjing Gao
Clinical Professor
Qilu Hospital of Shandong University