Endoscopic Submucosal Dissection Registry

NCT06033976 | Recruiting

• 1 other identifier: ESDREG
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neoplasm, Stomach; Neoplasm, Colorectal; Neoplasm, Esophagus; Neoplasm, Duodenal

Outcome Measures

Primary Outcomes (1)

• Rate of curative resection

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Rate of R0 resection

  through study completion, an average of 1 year

Other Outcomes (2)

• Rate of perforation

  30 days

• Rate of delayed bleeding

  30 days

Interventions

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.

Also known as: ESD

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed at or referred to Gastroenterology Clinic, University of Medicine and Pharmacy, "Agrippa Ionescu" Hospital, Bucharest, Romania

You may qualify if:

• 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

You may not qualify if:

• age \< 18 years old
• no informed consent

Sponsors & Collaborators

• Carol Davila University of Medicine and Pharmacy: lead

Study Sites (1)

"Agrippa Ionescu" Hospital

Bucharest, Romania

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Resected specimens of the gastrointestinal tract, fixed in formalin

MeSH Terms

Conditions

Stomach Neoplasms; Colorectal Neoplasms; Esophageal Neoplasms; Duodenal Neoplasms

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Duodenal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Mihai L Ciocirlan, Associate Professor

  Carol Davila University of Medicine and Pharmacy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ciocirlan L Mihai, Associate Professor

CONTACT

0040722322625; mihai.ciocirlan@umfcd.ro

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor (Associate Professor)

Study Record Dates

• First Submitted: September 3, 2023
• First Posted: September 13, 2023
• Study Start: January 1, 2021
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2031
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)