Endoscopic Resection Multicenter Registry

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03065257

Collaborator

(none)

200

Enrollment

Location

36.6

Anticipated Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	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 Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Endoscopic Resection: A Retrospective and Prospective Multicenter Registry

Actual Study Start Date :

Mar 15, 2017

Anticipated Primary Completion Date :

Mar 1, 2020

Anticipated Study Completion Date :

Apr 1, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Endoscopic Resection

Patients undergoing Endoscopic Resection

Procedure: Endoscopic Resection

Any Endoscopic resection for Gastrointestinal disorders including neoplasms.

Outcome Measures

Primary Outcome Measures

Number of participants with reduction in clinical symptoms [6 months from procedure]
To assess resolution of symptoms of all Endoscopic resection procedures at 6 months

Secondary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [30 days post procedure]
Number of subjects with Adverse Events; Type, frequency and intensity of adverse events within 30 days of procedure

Other Outcome Measures

Number of participants with successful completion of treatment [30 days post procedure]
Number of participants with successful completion of treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.