Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Endoscopic Resection Multicenter Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03065257
Recruitment Status : Recruiting
First Posted : February 27, 2017
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Michel Kahaleh, Weill Medical College of Cornell University

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
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).


Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Endoscopic Resection: A Retrospective and Prospective Multicenter Registry
Actual Study Start Date : March 15, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. Number of participants with successful completion of treatment [ Time Frame: 30 days post procedure ]
    Number of participants with successful completion of treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects undergoing Endoscopic resection procedures as part of their clinically indicated care
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03065257


Contacts
Layout table for location contacts
Contact: Michel Kahaleh, MD 646-962-4797 mik9071@med.cornell.edu
Contact: Monica R Gaidhane, MPH 646-962-4796 mog2012@med.cornell.edu

Locations
Layout table for location information
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
Contact: Michel Kahaleh, MD    646-962-4797    mik9071@med.cornell.edu   
Contact: Monica R Gaidhane, MPH    646-962-4796    mog2012@med.cornell.edu   
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Layout table for investigator information
Principal Investigator: Michel Kahaleh, MD Weill Medical College of Cornell University

Layout table for additonal information
Responsible Party: Michel Kahaleh, Chief of Endoscopy, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03065257     History of Changes
Other Study ID Numbers: 1701017930
First Posted: February 27, 2017    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD Sharing

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michel Kahaleh, Weill Medical College of Cornell University:
EMR
ESD
Resection
STER
EFTR
Submucosal dissection
Endoscopic resection

Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms
Polyps
Stomach Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Colonic Neoplasms
Duodenal Neoplasms
Pathological Conditions, Anatomical
Neoplasms by Site
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Colonic Diseases
Intestinal Diseases
Duodenal Diseases