We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified August 2016 by Kenneth Binmoeller, California Pacific Medical Center Research Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT01750619
First Posted: December 17, 2012
Last Update Posted: August 25, 2016
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.
Information provided by (Responsible Party):
Kenneth Binmoeller, California Pacific Medical Center Research Institute
  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. 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
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:


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

Primary Outcome Measures:
  • 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:
  • 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

  • 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

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

  • 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


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

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.


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
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): 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 Submitted: December 12, 2012
First Posted: December 17, 2012
Last Update Posted: August 25, 2016
Last Verified: August 2016

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