Endoscopic Resection Multicenter Registry

Endoscopic Resection: A Retrospective and Prospective Multicenter Registry

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.

Study Overview

• Status: Unknown
• Conditions: Neoplasms; Gastrointestinal Neoplasms; Gastric Cancer; Esophageal Neoplasms; Gastrointestinal Disease; Colon Polyp; Stomach Neoplasm; Gastric Neoplasm; Duodenal Neoplasms; Colon Neoplasm; Gastric Polyp; Duodenal Polyp; Stomach Polyp
• Intervention / Treatment: Procedure: Endoscopic Resection

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).

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Weill Cornell Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Endoscopic Resection; Patients undergoing Endoscopic Resection	Procedure: Endoscopic Resection; Any Endoscopic resection for Gastrointestinal disorders including neoplasms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with successful completion of treatment	Number of participants with successful completion of treatment	30 days post procedure

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2017
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): April 1, 2020

Study Registration Dates

• First Submitted: February 16, 2017
• First Submitted That Met QC Criteria: February 22, 2017
• First Posted (Actual): February 27, 2017

Study Record Updates

• Last Update Posted (Actual): April 25, 2017
• Last Update Submitted That Met QC Criteria: April 21, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: ESD; Resection; Endoscopic resection; STER; EFTR; EMR; Submucosal dissection
• Additional Relevant MeSH Terms: Neoplasms by Site; Stomach Diseases; Head and Neck Neoplasms; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Esophageal Diseases; Duodenal Diseases; Colorectal Neoplasms; Neoplasms; Stomach Neoplasms; Gastrointestinal Diseases; Digestive System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Polyps; Esophageal Neoplasms; Colonic Neoplasms; Duodenal Neoplasms
• Other Study ID Numbers: 1701017930

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD Sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No