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

NCT04994548 | Completed

• 1 other identifier: 2019PI67
• Study Type: observational
• Target: 112
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Esophageal Neoplasms; Cirrhosis; Portal Hypertension

Outcome Measures

Primary Outcomes (1)

• technical success of early esophageal cancer resection

  defined by a complete macroscopic resection

  baseline

Secondary Outcomes (4)

• 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

Study Arms (1)

Cirrhotic patients or with portal hypertension

Patients with early esophageal cancer

Procedure: Endosocpic resection of early esophageal tumor

Interventions

Endosocpic resection of early esophageal tumor PROCEDURE

under general anesthesia, by mucosectomy or endoscopic submucosal dissection

Cirrhotic patients or with portal hypertension

Eligibility Criteria

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

Study Population

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

You may qualify if:

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

You may not qualify if:

• younger than 18

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

MeSH Terms

Conditions

Esophageal Neoplasms; Fibrosis; Hypertension, Portal

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 6, 2021
• Study Start: January 1, 2005
• Primary Completion: February 3, 2005
• Study Completion: March 31, 2021
• Last Updated: August 6, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share