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

NCT07368309 | Completed DMC

• 1 other identifier: WDRY2023-K116
• Study Type: observational
• Target: 206
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhosis; Esophagogastric Varices; Early-stage Upper Gastrointestinal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• Other intra/postoperative adverse events

  Perioperative

• Procedure time

  Perioperative

• ESD efficiency

  Perioperative

Other Outcomes (2)

• Other cirrhosis complication

  Perioperative

• Hospitalization duration

  Perioperative

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

Fibrosis; Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Mingkai Chen

  Renmin Hospital of Wuhan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Gastroenterology

Study Record Dates

• First Submitted: January 11, 2026
• First Posted: January 26, 2026
• Study Start: August 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2025
• Last Updated: January 26, 2026

Record last verified: 2024-12

Locations

CN (1)