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

Definition: Recurrence is defined as the reappearance or worsening of esophageal or gastric varices confirmed by endoscopic examination, meeting one of the following criteria: Newly detected varices (≥ Grade 1 based on the Sarin classification or equivalent grading system). Progression of existing varices (e.g., increase in size, red wale marks, or high-risk stigmata such as cherry-red spots or hematocystic spots). Rebleeding events attributable to recurrent varices during follow-up.

Assessment Methods: Scheduled endoscopic evaluations at 3 months, 6 months, and 12 months post-enrollment. Additional unscheduled endoscopy if clinical symptoms (e.g., hematemesis, melena) suggest potential rebleeding.

Data Collection: Endoscopic images and reports will be independently reviewed by two blinded gastroenterologists to ensure consistency. Time to recurrence (days from enrollment to recurrence) and recurrence severity (grade/stigmata) will be recorded.

Definition: All-cause mortality within 1 year post-enrollment, including: Deaths directly related to variceal rebleeding (e.g., hemorrhagic shock, multiorgan failure secondary to bleeding). Deaths from liver disease complications (e.g., hepatic encephalopathy, hepatorenal syndrome). Non-liver-related deaths (e.g., cardiovascular events, infections).

Assessment Methods: Continuous follow-up via hospital records, outpatient visits, or telephone interviews at 1, 3, 6, and 12 months. Cause of death will be determined by clinical documentation or autopsy reports (if available).

Data Collection: Date and cause of death will be documented, with adjudication by an independent endpoint committee to minimize bias.

Definition: Overt HE is defined as clinically apparent neuropsychiatric impairment graded ≥ Stage 1 according to the West Haven criteria, including: Stage 1: Mild confusion, euphoria, or irritability; impaired attention; altered sleep rhythm. Stage 2: Lethargy, disorientation, personality changes, asterixis. Stage 3: Somnolence to stupor, marked confusion, incoherent speech. Stage 4: Coma. Episodes must be documented by a clinician and require intervention (e.g., lactulose, rifaximin, hospitalization).

Assessment Methods: Regular follow-ups at 1, 3, 6, and 12 months post-enrollment, including: Clinical evaluation for HE symptoms (e.g., mental status, asterixis). Patient/caregiver-reported symptoms (e.g., sleep disturbances, confusion). Laboratory tests (e.g., ammonia levels, if clinically indicated).

Data Collection: HE episodes will be recorded with details on severity (stage), duration, triggering factors (e.g., infections, constipation), and treatment interventions.

Definitions: Total Hospitalization Days: Cumulative inpatient days from enrollment to 1 year, including all admissions (e.g., rebleeding, HE, infections). Post-Endotherapy Hospitalization Days: Length of stay (LOS) specifically after each endoscopic treatment session.

Assessment Methods: Extracted from electronic medical records for all hospitalizations during follow-up. Differentiate between planned admissions (e.g., scheduled endotherapy) and unplanned admissions (e.g., rebleeding).

Data Collection: Document reasons for hospitalization, LOS, and ICU stays (if applicable). Standardized reporting to minimize variability (e.g., exclude days unrelated to liver disease).

Definition: Total direct medical costs during hospitalization, including inpatient costs (beds, drugs, procedures). Costs converted to a standard currency (e.g., USD) using institutional financial databases.

Assessment Methods: Itemized cost data retrieved from hospital billing systems, verified for accuracy. Exclude indirect costs (e.g., lost productivity) to focus on healthcare system burden.