Endoscopic Resection Multicenter Registry

Study Overview
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Brief Summary
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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 Description
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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).

Official Title
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Endoscopic Resection: A Retrospective and Prospective Multicenter Registry

Conditions
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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

Intervention / Treatment
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* Procedure: Endoscopic Resection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endoscopic Resection<br>Patients undergoing Endoscopic Resection | Procedure: Endoscopic Resection<br>* Any Endoscopic resection for Gastrointestinal disorders including neoplasms.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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STER, EMR, ESD, Resection, EFTR, Submucosal dissection, Endoscopic resection