Endoscopic Resection Multicenter Registry

NCT03065257 | Unknown

• 1 other identifier: 1701017930
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

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

Keywords

EMR; ESD; Resection; STER; EFTR; Submucosal dissection; Endoscopic resection

Outcome Measures

Primary Outcomes (1)

• Number of participants with reduction in clinical symptoms

  To assess resolution of symptoms of all Endoscopic resection procedures at 6 months

  6 months from procedure

Secondary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  30 days post procedure

Other Outcomes (1)

• Number of participants with successful completion of treatment

  30 days post procedure

Study Arms (1)

Endoscopic Resection

Patients undergoing Endoscopic Resection

Procedure: Endoscopic Resection

Interventions

Endoscopic Resection PROCEDURE

Any Endoscopic resection for Gastrointestinal disorders including neoplasms.

Endoscopic Resection

Eligibility Criteria

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

Study Population

Subjects undergoing Endoscopic resection procedures as part of their clinically indicated care

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Gastrointestinal Diseases; Stomach Neoplasms; Polyposis, Gastric; Esophageal Neoplasms; Duodenal Neoplasms; Neoplasms; Colonic Polyps; Colonic Neoplasms

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases; Intestinal Neoplasms; Duodenal Diseases; Intestinal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Colonic 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

• Michel Kahaleh, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michel Kahaleh, MD

CONTACT

646-962-4797; mik9071@med.cornell.edu

Monica R Gaidhane, MPH

CONTACT

646-962-4796; mog2012@med.cornell.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Endoscopy

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: February 27, 2017
• Study Start: March 15, 2017
• Primary Completion: March 1, 2020
• Study Completion: April 1, 2020
• Last Updated: April 25, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)