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

This study is currently recruiting participants.
Verified December 2012 by California Pacific Medical Center Research Institute
Sponsor:
Information provided by (Responsible Party):
Kenneth Binmoeller, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01750619
First received: December 12, 2012
Last updated: December 27, 2012
Last verified: December 2012
History of Changes
  Purpose

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, and the secondary outcomes are complication rates, such as infection, bleeding, perforation and death, and one-year survival rates.


Condition
Gastrointestinal Neoplasms
Benign Neoplasm of Intestinal Tract

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Outcomes of the Endoscopic Resection of Premalignant and Malignant Gastrointestinal Lesions

Resource links provided by NLM:

MedlinePlus related topics: Cancer Endoscopy
U.S. FDA Resources

Further study details as provided by California Pacific Medical Center Research Institute:

Primary Outcome Measures:
  • Technical success. [ Time Frame: 1 day to 3 months ] [ Designated as safety issue: No ]
    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:
  • Short term recurrence rate [ Time Frame: Less than 1 year ] [ Designated as safety issue: No ]
    Freedom from recurrence on follow-up endoscopy with HD white light and NBI and on mucosal biopsies of the EMR site

  • Long term recurrence rate [ Time Frame: Greater than 1 year ] [ Designated as safety issue: No ]
    Freedom from recurrence on follow-up endoscopy with HD white light and NBI and on mucosal biopsies of the EMR site

  • Adverse event rate [ Time Frame: up to 1 month post procedure. ] [ Designated as safety issue: Yes ]
    Adverse events include infection, bleeding, perforation and death.


Estimated Enrollment: 1000
Study Start Date: July 2011
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01750619

Contacts
Contact: Steve D Kane kanesd@sutterhealth.org

Locations
United States, California
Interventional Endoscopy Services Recruiting
San Francisco, California, United States, 94115
Contact: Steve D Kane         kanesd@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

No publications provided

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
Study First Received: December 12, 2012
Last Updated: December 27, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 18, 2013