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Clinical Trials/NCT07368309
NCT07368309CompletedNot Applicable

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

Renmin Hospital of Wuhan University1 site in 1 country206 target enrollmentStarted: August 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
206
Locations
1
Primary Endpoint
Mortality

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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.

Arms & Interventions

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

Outcomes

Primary Outcomes

Mortality

Time Frame: Perioperative

Patients who died due to ESD

ICU transfer

Time Frame: Perioperative

Transferred to ICU due to ESD

Intraoperative major bleeding

Time Frame: Perioperative

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

en bloc resection rate

Time Frame: Perioperative

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

R0 resection

Time Frame: Perioperative

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

Delayed bleeding

Time Frame: Perioperative

Delayed bleeding was defined as any evidence of gastrointestinal hemorrhage

Secondary Outcomes

  • Other intra/postoperative adverse events(Perioperative)
  • Procedure time(Perioperative)
  • ESD efficiency(Perioperative)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

ChenMingkai

Department of Gastroenterology

Renmin Hospital of Wuhan University

Study Sites (1)

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