Feasibility and Safety Evaluation of Endoscopic Treatment of Esophagogastric Varices in Cirrhosis on the Day-care Unit

NCT ID: NCT07129447

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 330 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2029-12-30

Brief Summary

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.

Detailed Description

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.

Conditions

Liver Cirrhosis; Gastroesophageal Varices

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

General Ward Group

Study subjects who underwent reendoscopic treatment of cirrhotic esophagogastric varices who presented to the gastroenterology department of our hospital between 2023.10 and 2024.10 were retrospectively included as a control group.

No interventions assigned to this group

Daytime Ward Group

Study participants who underwent reendoscopic treatment of cirrhotic esophagogastric varices who presented to our gastrointestinal endoscopy day unit from 2025.5-2028.12 were prospectively included as the day unit group.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. aged 18-75 years;

2. diagnosis of cirrhosis and portal hypertension by clinical manifestations, laboratory tests, imaging tests and histologic examinations;

3. gastroscopic grading of esophagogastric varices as moderate or severe;

4. no ruptured esophagogastric varices bleeding in the last 5 days;

5. endoscopic treatment of esophagogastric varices during hospitalization.

Exclusion Criteria

1. first endoscopic treatment of esophagogastric varices;

2. this is an acute esophagogastric variceal rupture and bleeding;

3. previous TIPS or liver transplantation;

4. isolated fundal varices or ectopic varices;

5. primary hepatocellular carcinoma or acute or chronic hepatic failure, Child-pugh class C, hepatic encephalopathy stage 2 or higher;

6. spontaneous abnormally large shunts, uncontrolled infections and sepsis, uncontrolled hypertension;

7. combined cardiac, pulmonary, cerebral, renal and other serious complications or other reasons for not being able to tolerate the examination;

8. pregnant women and lactating women;

9. failure to sign the informed consent or refusal to participate.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Yanjing Gao

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

20250415-QiluH

Identifier Type: -

Identifier Source: org_study_id