Endoscopic Resection of Early Esophageal Tumors in the Context of Cirrhosis or Portal Hypertension

Endoscopic Resection of Early Esophageal Tumors in the Context of Cirrhosis or Portal Hypertension: a Multicenter Observational Study

Cirrhotic patients may be at high risk for esophageal cancer. Endoscopic resection is the standard treatment for superficial tumors. However, cirrhosis might be associated with upper gastrointestinal bleeding, particularly in case of portal hypertension or coagulopathy. This study aims to assess safety, efficacy and methods to prevent potential complications in cirrhosis or portal hypertension context for esophageal endoscopic resection.

This retrospective multicentric French-Belgian study includes all consecutive patients with cirrhosis or portal hypertension who underwent esophageal endoscopic resection from January 2005 to 2021.

Study Overview

• Status: Completed
• Conditions: Esophageal Neoplasms; Cirrhosis; Portal Hypertension
• Intervention / Treatment: Procedure: Endosocpic resection of early esophageal tumor

• Study Type: Observational
• Enrollment (Actual): 112

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Study Population

112 patients with cirrhosis or portal hypertension who underwent endoscopic resection of an early esophageal tumor

Description

Inclusion Criteria:

• older than 18 years with cirrhosis or portal hypertension who underwent endoscopic resection of an early esophageal tumor

Exclusion Criteria:

• younger than 18

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cirrhotic patients or with portal hypertension; Patients with early esophageal cancer	Procedure: Endosocpic resection of early esophageal tumor; under general anesthesia, by mucosectomy or endoscopic submucosal dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
technical success of early esophageal cancer resection	defined by a complete macroscopic resection	baseline

Secondary Outcome Measures

Outcome Measure	Time Frame
adverse events per procedure (immediate bleeding, perforation)	baseline
morbidity post procedure (delayed bleeding, infection, esophageal stenosis, 30-days related liver decompensation, 30-days related mortality)	up to 4 weeks
Potential risk factors for adverse events	baseline
preemptive methods to the risk of bleeding	baseline

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2005
• Primary Completion (Actual): February 3, 2005
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: July 29, 2021
• First Submitted That Met QC Criteria: July 29, 2021
• First Posted (Actual): August 6, 2021

Study Record Updates

• Last Update Posted (Actual): August 6, 2021
• Last Update Submitted That Met QC Criteria: July 29, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Liver Diseases; Head and Neck Neoplasms; Esophageal Diseases; Fibrosis; Hypertension; Liver Cirrhosis; Esophageal Neoplasms; Hypertension, Portal
• Other Study ID Numbers: 2019PI67

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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