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

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04994548
• Other study ID #: 2019PI67
• Status: Completed
• Start date: January 1, 2005
• Est. completion date: March 31, 2021

Study information

• Verified date: July 2021
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: March 31, 2021
• Est. primary completion date: February 3, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• Esophageal Neoplasms
• Fibrosis
• Hypertension
• Hypertension, Portal
• Liver Cirrhosis
• Portal Hypertension

Intervention

Procedure:
• Endosocpic resection of early esophageal tumor
under general anesthesia, by mucosectomy or endoscopic submucosal dissection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	technical success of early esophageal cancer resection	defined by a complete macroscopic resection	baseline
Secondary	adverse events per procedure (immediate bleeding, perforation)		baseline
Secondary	morbidity post procedure (delayed bleeding, infection, esophageal stenosis, 30-days related liver decompensation, 30-days related mortality)		up to 4 weeks
Secondary	Potential risk factors for adverse events		baseline
Secondary	preemptive methods to the risk of bleeding		baseline