Endoscopic Resection Multicenter Registry

Gastric Cancer Clinical Trial

Official title:

Endoscopic Resection: A Retrospective and Prospective Multicenter Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03065257
• Other study ID #: 1701017930
• Status: Recruiting
• Phase: N/A
• First received: February 16, 2017
• Last updated: April 21, 2017
• Start date: March 15, 2017
• Est. completion date: April 2020

Study information

• Verified date: April 2017
• Source: Weill Medical College of Cornell University
• Contact: Michel Kahaleh, MD
• Phone: 646-962-4797
• Email: mik9071[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colon Neoplasm
• Colon Polyp
• Colonic Neoplasms
• Digestive System Diseases
• Digestive System Neoplasms
• Duodenal Neoplasms
• Duodenal Polyp
• Esophageal Neoplasms
• Gastric Cancer
• Gastric Neoplasm
• Gastric Polyp
• Gastrointestinal Disease
• Gastrointestinal Diseases
• Gastrointestinal Neoplasms
• Neoplasms
• Polyps
• Stomach Neoplasm
• Stomach Neoplasms
• Stomach Polyp

Intervention

Procedure:
• Endoscopic Resection
Any Endoscopic resection for Gastrointestinal disorders including neoplasms.

Locations

Country	Name	City	State
United States	Weill Cornell Medical College	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with successful completion of treatment	Number of participants with successful completion of treatment	30 days post procedure
Primary	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	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Number of subjects with Adverse Events; Type, frequency and intensity of adverse events within 30 days of procedure	30 days post procedure