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Recruiting NCT06033976

Endoscopic Submucosal Dissection Registry

— Observational Neoplasm, Stomach Neoplasm, Colorectal Neoplasm, Esophagus Neoplasm, Duodenal

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endoscopic submucosal dissection (ESD).
Who it may be relevant to
Registry conditions: Neoplasm, Stomach, Neoplasm, Colorectal, Neoplasm, Esophagus, Neoplasm, Duodenal. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Romania
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Endoscopic Submucosal Dissection Patients Registry in "Agrippa Ionescu" Hospital, Bucharest, Romania

Overview

This is a patient registry for all cases of pre-neoplastic or early neoplastic digestive tract lesions treated with curative intention by endoscopic submucosal dissection (ESD) technique.

Detailed description

Cases will be registered one by one in an electronic record, with the consent of the patient and respecting all legal requirements.

Interventions

  • Procedure Endoscopic submucosal dissection (ESD)
    Endoscopic injection of fluid into the gastrointestinal submucosal space followed by endoscopic knife dissection around and under the lesion so as to remove the lesion specimen in one piece with lesion free resection margins.

Primary outcome measures

  • Rate of curative resection [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (1)
  • Rate of R0 resection [Time frame: through study completion, an average of 1 year]

Eligibility criteria

Inclusion criteria

  • epithelial pre-neoplastic (eg. adenoma, dysplasia) lesion on the esophageal, gastric, duodenal or colorectal mucosa
  • non-epithelial (eg. neuroendocrine tumor) lesion on the esophageal, gastric, duodenal or colorectal mucosa
  • age > 18 years old
  • informed consent

Exclusion criteria

  • age < 18 years old
  • no informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Romania · 1 center
  • "Agrippa Ionescu" Hospital — Bucharest

Identifiers

NCT: NCT06033976 · ESDREG

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗