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NCT Number: NCT06033976

Endoscopic Submucosal Dissection Registry

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.

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Key information

Conditions

Neoplasm, Stomach Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Duodenal Diseases Duodenal Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasm, Colorectal Neoplasm, Duodenal Neoplasm, Esophagus Neoplasms Neoplasms by Site Rectal Diseases Stomach Diseases Stomach Neoplasms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Endoscopic submucosal dissection (ESD)

Procedure

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.

Other names: ESD

Primary outcomes

  1. Rate of curative resection

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. Rate of R0 resection

    Time frame: through study completion, an average of 1 year

Other outcomes

  1. Rate of perforation

    Time frame: 30 days

  2. Rate of delayed bleeding

    Time frame: 30 days

Study contacts

Contact information is provided by the study sponsor or research team.

Ciocirlan L Mihai, Associate Professor

CONTACT

[email protected]

0040722322625

Sponsors and collaborators

Lead sponsor

Carol Davila University of Medicine and Pharmacy

Other

Registry information

Official study title

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

Acronym: ESDREG

Important dates

Study start
2021
Primary completion
2031
Study completion
2031
First posted
Sep 13, 2023
Registry last updated
Nov 12, 2024

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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