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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04994548
Enrollment
112
Registered
2021-08-06
Start date
2005-01-01
Completion date
2021-03-31
Last updated
2021-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Esophageal Neoplasms, Portal Hypertension

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.

Interventions

PROCEDUREEndosocpic resection of early esophageal tumor

under general anesthesia, by mucosectomy or endoscopic submucosal dissection

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
technical success of early esophageal cancer resectionbaselinedefined by a complete macroscopic resection

Secondary

MeasureTime 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 eventsbaseline
preemptive methods to the risk of bleedingbaseline

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026