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Clinical Outcomes of the Endoscopic Resection of Premalignant and Malignant Gastrointestinal Lesions

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ClinicalTrials.gov Identifier: NCT01750619
Recruitment Status : Recruiting
First Posted : December 17, 2012
Last Update Posted : December 20, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To evaluate clinical outcome for patients receiving treatment of suspected premalignant and malignant gastrointestinal lesions at Interventional Endoscopy Services. The primary outcome is curative endoscopic resection. Secondary outcomes include resection technique utilized, rates of en bloc resection and adverse event rates, including infection, bleeding, perforation and death, and one-year survival rates.

Condition or disease
Gastrointestinal Neoplasms Benign Neoplasm of Intestinal Tract

Study Design

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Outcomes of the Endoscopic Resection of Premalignant and Malignant Gastrointestinal Lesions
Study Start Date : July 2011
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Mucosal tumors of the colon
Patients who received endoscopic treatment for noninvasive mucosal tumors of the colon.
Nonampullary tumors of the duodenum
Patients who received endoscopic treatment for noninvasive mucosal tumors of the duodenum.
Ampullary tumors
Patients who received endoscopic treatment for noninvasive ampullary tumors.


Outcome Measures

Primary Outcome Measures :
  1. Technical success. [ Time Frame: 1 day to 3 months ]
    Technical success is defined as complete resection confirmed by the endoscopic absence of adenomatous tissue after inspection with high-definition white light and narrow-band imaging.


Secondary Outcome Measures :
  1. Short term recurrence rate [ Time Frame: Less than 1 year ]
    Freedom from recurrence on follow-up endoscopy with high definition white light and narrow band imaging and on mucosal biopsies of the endoscopic mucosal resection site

  2. Long term recurrence rate [ Time Frame: Greater than 1 year ]
    Freedom from recurrence on follow-up endoscopy with high definition white light and narrow band imaging and on mucosal biopsies of the endoscopic mucosal resection site

  3. Adverse event rate [ Time Frame: up to 1 month post procedure. ]
    Adverse events include infection, bleeding, perforation and death.

  4. Endoscopic en bloc resection rate [ Time Frame: Immediate ]
    Resection in 1 piece without fragmentation, along or extrinsic to the diathermic markings placed around the perimeter of the lesion before resection, without remnant abnormal tissue visible on HD white-light imaging or NBI


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients referred to Interventional Endoscopy Services at CPMC for treatment of GI tract tumors.
Criteria

Inclusion Criteria:

  • Patients age >18 years that have been referred for endoscopic treatment of GI lesions.

Exclusion Criteria:

  • Patients who do not sign informed consent
  • Patients for whom endoscopic treatment was not performed.
Contacts and Locations

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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): NCT01750619


Contacts
Contact: Jona Calitis 415-600-1151

Locations
United States, California
Interventional Endoscopy Services Recruiting
San Francisco, California, United States, 94115
Contact: Jona Calitis       CalitiJ@sutterhealth.org   
Sponsors and Collaborators
California Pacific Medical Center Research Institute
Investigators
Principal Investigator: Kenneth F Binmoeller, M.D. California Pacific Medical Center
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kenneth Binmoeller, Interventional Endoscopy Services Program Director, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01750619     History of Changes
Other Study ID Numbers: 2011.090
First Posted: December 17, 2012    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Precancerous Conditions
Intestinal Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases