Clinical Trial: Endoscopic Resection Multicenter Registry

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Endoscopic Resection: A Retrospective and Prospective Multicenter Registry

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 Summary:

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).


Sponsor: Weill Medical College of Cornell University

Current Primary Outcome: Number of participants with reduction in clinical symptoms [ Time Frame: 6 months from procedure ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 30 days post procedure ]

Number of subjects with Adverse Events; Type, frequency and intensity of adverse events within 30 days of procedure


Original Secondary Outcome: Same as current

Information By: Weill Medical College of Cornell University

Dates:
Date Received: February 16, 2017
Date Started: March 15, 2017
Date Completion: April 2020
Last Updated: April 21, 2017
Last Verified: April 2017