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OpenTrials
Completed

NCT Number: NCT04994548

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

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.

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Key information

Conditions

Esophageal Neoplasms Cirrhosis Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Fibrosis Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Hypertension, Portal Liver Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Portal Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endosocpic resection of early esophageal tumor

Procedure

under general anesthesia, by mucosectomy or endoscopic submucosal dissection

Primary outcomes

  1. technical success of early esophageal cancer resection

    Time frame: baseline

    defined by a complete macroscopic resection

Secondary outcomes

  1. adverse events per procedure (immediate bleeding, perforation)

    Time frame: baseline

  2. morbidity post procedure (delayed bleeding, infection, esophageal stenosis, 30-days related liver decompensation, 30-days related mortality)

    Time frame: up to 4 weeks

  3. Potential risk factors for adverse events

    Time frame: baseline

  4. preemptive methods to the risk of bleeding

    Time frame: baseline

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2005
Study completion
2021
First posted
Aug 6, 2021
Registry last updated
Aug 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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