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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07368309
Enrollment
206
Registered
2026-01-26
Start date
2023-08-01
Completion date
2025-12-01
Last updated
2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Early-stage Upper Gastrointestinal Cancer, Esophagogastric Varices

Keywords

Cirrhosis, Endoscopic submucosal dissection, Esophagogastric varices, Early-stage upper gastrointestinal cancer

Brief summary

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.

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.

Interventions

None listed

Sponsors

Renmin Hospital of Wuhan University
Lead SponsorOTHER
Southwest Hospital, China
CollaboratorOTHER
Shanxi Coal Central Hospital
CollaboratorUNKNOWN
Beijing Friendship Hospital
CollaboratorOTHER
The Second Affiliated Hospital of Chongqing Medical University
CollaboratorOTHER
Tongji Hospital Affiliated to Tongji Medical College of HUST
CollaboratorUNKNOWN
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
MortalityPerioperativePatients who died due to ESD
ICU transferPerioperativeTransferred to ICU due to ESD
Intraoperative major bleedingPerioperativeIntraoperative major bleeding was defined as active bleeding requiring specific endoscopic hemostasis
en bloc resection ratePerioperativeEn bloc resection was complete removal of the lesion in one piece without fragmentation
R0 resectionPerioperativeR0 resection was histopathological confirmation of tumour-free lateral and vertical margins
Delayed bleedingPerioperativeDelayed bleeding was defined as any evidence of gastrointestinal hemorrhage

Secondary

MeasureTime frameDescription
Other intra/postoperative adverse eventsPerioperativeIntraoperative perforation, fever, esophageal stricture, delayed perforation, pain, and nausea/vomiting
Procedure timePerioperativeESD operation time
ESD efficiencyPerioperativeThe average time required to resect lesions per square centimeter

Countries

China

Contacts

PRINCIPAL_INVESTIGATORMingkai Chen

Renmin Hospital of Wuhan University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026