Endoscopic Resection Multicenter Registry

NCT ID: NCT03065257

Last Updated: 2017-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-15
• Study Completion Date: 2020-04-30

Brief Summary

This is a retrospective and prospective multicenter registry to collect long-term data (1 year) on patients who have or will undergo Endoscopic resection such as EMR, ESD, EFTR, STER, etc. within the gastrointestinal tract for endoscopic treatment of early gastrointestinal neoplasms involving the resection of the superficial layers, mucosa and submucosa, of the tract wall.

Subjects will be consented for medical chart review.

The purpose of this retrospective and prospective registry is to assess long term data on efficacy, safety and clinical outcome of Endoscopic Resection within the gastrointestinal tract (1 year).

The registry will evaluate efficacy, technical feasibility, clinical outcome, safety profile and overall clinical management through medical chart review. The procedures the investigators are evaluating are all clinically indicated and will not be prescribed to someone to participate in this registry study.

Detailed Description

Endoscopic resection can be an appropriate approach in early neoplasms, challenging adenomas or sub-epithelial lesions. Endoscopic resection can be considered as a less invasive approach than surgery. Moreover, endoscopic resection can be available to patients who are ineligible for surgery or who have refused more aggressive surgical intervention.

The study investigators would collect data on a large sample size of subjects undergoing various endoscopic resection procedures such as EMR (Endoscopic Mucosal Resection), ESD (Endoscopic submucosal dissection), STER (Submucosal tunneling endoscopic resection, and EFTR (Endoscopic full-thickness resection). Clinical metrics will be recorded including procedure times, length of follow-up, specific tumor characteristics, resection method, pathology results, procedural complications, additional therapy required, and disease-free survival time.

Currently, there is limited multi-center data on endoscopic resection outcomes in western populations.

Evaluation of these measurement would help the investigators compare them to conventional treatment modalities within current tertiary facilities; and consequently help the investigators identify appropriate treatment techniques and improve clinical management of patients at WCMC-NYPH.

The purpose of this retrospective and prospective registry is to assess long term data on efficacy, safety and clinical outcome of Endoscopic Resection within the gastrointestinal tract (1 year).

Conditions

Gastrointestinal Neoplasms; Gastrointestinal Disease; Gastric Cancer; Gastric Neoplasm; Gastric Polyp; Esophageal Neoplasms; Duodenal Neoplasms; Duodenal Polyp; Stomach Neoplasm; Stomach Polyp; Neoplasms; Colon Polyp; Colon Neoplasm

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Endoscopic Resection

Patients undergoing Endoscopic Resection

Endoscopic Resection

Intervention Type: PROCEDURE

Any Endoscopic resection for Gastrointestinal disorders including neoplasms.

Interventions

Endoscopic Resection

Any Endoscopic resection for Gastrointestinal disorders including neoplasms.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Any patient who is considering undergoing endoscopic resection within 6 months, or has undergone clinically indicated endoscopic resection within the past 6 months
• Above or equal to 18 years of age.

Exclusion Criteria

• Any patient who has not undergone or will undergo endoscopic resection
• Below 18 years of age.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Michel Kahaleh

Chief of Endoscopy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michel Kahaleh, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medical College

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michel Kahaleh, MD

Role: CONTACT

mik9071@med.cornell.edu

646-962-4797

Monica R Gaidhane, MPH

Role: CONTACT

mog2012@med.cornell.edu

646-962-4796

Facility Contacts

Michel Kahaleh, MD

Role: primary

mik9071@med.cornell.edu

646-962-4797

Monica R Gaidhane, MPH

Role: backup

mog2012@med.cornell.edu

646-962-4796

Other Identifiers

1701017930

Identifier Type: -

Identifier Source: org_study_id