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NCT Number: NCT07368309

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Mortality

    Time frame: Perioperative

    Patients who died due to ESD

  2. ICU transfer

    Time frame: Perioperative

    Transferred to ICU due to ESD

  3. Intraoperative major bleeding

    Time frame: Perioperative

    Intraoperative major bleeding was defined as active bleeding requiring specific endoscopic hemostasis

  4. en bloc resection rate

    Time frame: Perioperative

    En bloc resection was complete removal of the lesion in one piece without fragmentation

  5. R0 resection

    Time frame: Perioperative

    R0 resection was histopathological confirmation of tumour-free lateral and vertical margins

  6. Delayed bleeding

    Time frame: Perioperative

    Delayed bleeding was defined as any evidence of gastrointestinal hemorrhage

Secondary outcomes

  1. Other intra/postoperative adverse events

    Time frame: Perioperative

    Intraoperative perforation, fever, esophageal stricture, delayed perforation, pain, and nausea/vomiting

  2. Procedure time

    Time frame: Perioperative

    ESD operation time

  3. ESD efficiency

    Time frame: Perioperative

    The average time required to resect lesions per square centimeter

Other outcomes

  1. Other cirrhosis complication

    Time frame: Perioperative

    New complications of liver cirrhosis due to ESD surgery

  2. Hospitalization duration

    Time frame: Perioperative

    The duration of hospitalization due to surgery

Sponsors and collaborators

Lead sponsor

Renmin Hospital of Wuhan University

Other

Collaborators

  • Beijing Friendship Hospital
  • Shanxi Coal Central Hospital
  • Southwest Hospital, China
  • The Second Affiliated Hospital of Chongqing Medical University
  • Tongji Hospital Affiliated to Tongji Medical College of HUST
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jan 26, 2026
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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