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

NCT07129447 | Not Yet Recruiting

• 1 other identifier: 20250415-QiluH
• Study Type: observational
• Target: 330
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Liver Cirrhosis; Gastroesophageal Varices

Keywords

Esophagogastric variceal bleeding; Liver cirrhosis; Endoscopic therapy; Day ward; Variceal rebleeding

Outcome Measures

Primary Outcomes (1)

• Variceal rebleeding rate at 1-year follow-up after enrollment

  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.

  1 years

Secondary Outcomes (5)

• Varicose vein recurrence rate within 1 year of follow-up after enrollment

  1 years

• 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

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study site: Digestive endoscopy day ward and general ward of the Department of Gastroenterology, Qilu Hospital, Shandong University, China. Study subjects: study participants who had undergone reendoscopic treatment of esophagogastric varices in cirrhosis.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 1, 2025
• First Posted: August 19, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2029
• Last Updated: August 19, 2025

Record last verified: 2025-05