Clinical Management Strategies for Patients With Cirrhosis and Esophagogastric Varices Complicated by Early-stage Upper Gastrointestinal Cancer

Clinical Management Strategies for Patients With Cirrhosis and Esophagogastric Varices Complicated by Early-stage Upper Gastrointestinal Cancer: a Multicenter Retrospective Cohort Study

Managing early-stage upper gastrointestinal cancer in patients with liver cirrhosis and esophagogastric varices (EGV) poses substantial clinical challenges. Although endoscopic submucosal dissection (ESD) is an established treatment for these early cancers, its efficacy and safety in this high-risk population are poorly defined. Therefore, this study aims to investigate optimal screening and treatment strategies for early-stage upper gastrointestinal cancer in cirrhotic patients with EGV. Perioperative outcomes were compared between the two groups.

Study Overview

• Status: Completed
• Conditions: Cirrhosis; Esophagogastric Varices; Early-stage Upper Gastrointestinal Cancer

Detailed Description

Oesophageal and gastric cancers remain leading causes of cancer-related morbidity and mortality worldwide. Early endoscopic screening is crucial, as it significantly improves prognosis. ESD has become the standard minimally invasive treatment for early-stage lesions because it enables en-bloc resection with rapid recovery and favourable cost-effectiveness.

In patients with liver cirrhosis and EGV, however, the management of early-stage upper gastrointestinal cancer is uniquely challenging. First, The detection of early-stage cancer depends on identifying subtle alterations in mucosal coloration and morphology, yet in cirrhotic patients these signs are masked by co-existing varices, portal-hypertensive gastropathy and accompanying mucosal changes, imposcope passage, obscuring inspection and raising the likelihood of missed cancers. Second, underlying coagulopathy and thrombocytopenia in these patients theoretically elevate the risk of procedure-related bleeding, especially when varices are adjacent to or located at the resection area. Presently, clinical guidelines provide no specific guidance for this high-risk population. Existing evidence is limited, derived mostly from small, single-arm studies. To establish a safe and effective standardized management protocol and to evaluate the feasibility of ESD in this setting, we conducted this multicentre, retrospective cohort study to inform clinical decision-making. This study was conducted at 7 tertiary hospitals in China. Consecutive patients who underwent ESD for early-stage upper gastrointestinal cancer between January 2018 and April 2023 were enrolled. Patients were stratified into a cirrhosis group (study group) and a noncirrhosis control group. Inclusion criteria for the study group were: age >18 years; a clinical diagnosis of liver cirrhosis; and endoscopically confirmed EGV. The noncirrhosis group comprised patients over 18 years with early-stage upper gastrointestinal cancer but without cirrhosis, randomly selected from the same pool. Common exclusion criteria were: concomitant end-stage disease of major organs (e.g., active malignancy, heart failure, respiratory failure) or an American Society of Anesthesiologists (ASA) physical status classification ≥ III; previous surgery for cirrhosis, EGV, or other upper gastrointestinal lesions; incomplete clinical records. Preoperative characteristics, demographic data, and perioperative management were compared between groups to inform the development of perioperative strategies for patients with cirrhosis and EGV. Trained investigators extracted demographic, laboratory, perioperative and postoperative outcome data from electronic medical records. Safety indicators included intra/postoperative adverse events, mortality, and ICU transfer. Efficacy indicators were en bloc resection rate, R0 resection rate, procedure time, and resection efficiency.

• Study Type: Observational
• Enrollment (Actual): 206

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Renmin Hospital of Wuhan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Consecutive patients who underwent ESD for early-stage upper gastrointestinal cancer between January 2018 and April 2023 were enrolled. See the previous entry for specific eligibility criteria

Description

Inclusion Criteria:

The cirrhosis group:

• Age >18 years;
• A clinical diagnosis of liver cirrhosis
• Endoscopically confirmed EGV.

The noncirrhosis group:

• Age > 18 years
• With early-stage upper gastrointestinal cancer but without cirrhosis

Exclusion Criteria:

• Concomitant end-stage disease of major organs (e.g., active malignancy, heart failure, respiratory failure) or an American Society of Anesthesiologists (ASA) physical status classification ≥ III
• Previous surgery for cirrhosis, EGV, or other upper gastrointestinal lesions
• Incomplete clinical records.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
cirrhosis group; cirrhotic patients with EGV and early-stage upper gastrointestinal cancer 问who underwent ESD
noncirrhosis group; Patients who underwent ESD without cirrhosis and EGV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Patients who died due to ESD	Perioperative
ICU transfer	Transferred to ICU due to ESD	Perioperative
Intraoperative major bleeding	Intraoperative major bleeding was defined as active bleeding requiring specific endoscopic hemostasis	Perioperative
en bloc resection rate	En bloc resection was complete removal of the lesion in one piece without fragmentation	Perioperative
R0 resection	R0 resection was histopathological confirmation of tumour-free lateral and vertical margins	Perioperative
Delayed bleeding	Delayed bleeding was defined as any evidence of gastrointestinal hemorrhage	Perioperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other intra/postoperative adverse events	Intraoperative perforation, fever, esophageal stricture, delayed perforation, pain, and nausea/vomiting	Perioperative
Procedure time	ESD operation time	Perioperative
ESD efficiency	The average time required to resect lesions per square centimeter	Perioperative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other cirrhosis complication	New complications of liver cirrhosis due to ESD surgery	Perioperative
Hospitalization duration	The duration of hospitalization due to surgery	Perioperative

Collaborators and Investigators

• Sponsor: Renmin Hospital of Wuhan University
• Collaborators: Beijing Friendship Hospital; Southwest Hospital, China; The Second Affiliated Hospital of Chongqing Medical University; Shanxi Coal Central Hospital; Tongji Hospital Affiliated to Tongji Medical College of HUST; Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
• Investigators: Principal Investigator: Mingkai Chen, Renmin Hospital of Wuhan University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): August 1, 2024
• Study Completion (Actual): December 1, 2025

Study Registration Dates

• First Submitted: January 11, 2026
• First Submitted That Met QC Criteria: January 18, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 18, 2026
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Endoscopic submucosal dissection; Cirrhosis; Esophagogastric varices; Early-stage upper gastrointestinal cancer
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Pathological Conditions, Signs and Symptoms; Gastrointestinal Neoplasms; Fibrosis
• Other Study ID Numbers: WDRY2023-K116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The patients included in the study are rare, and the data are precious and difficult to collect. However, if any researcher needs our data for secondary analysis (systematic review, etc.) after publication, they can contact us by email.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No