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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 : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Kenneth Binmoeller, California Pacific Medical Center Research Institute

Tracking Information
First Submitted Date December 12, 2012
First Posted Date December 17, 2012
Last Update Posted Date September 7, 2018
Study Start Date July 2011
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 27, 2012)
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.
Original Primary Outcome Measures
 (submitted: December 13, 2012)
Successful treatment of gastrointestinal tract tumor. [ Time Frame: 6 months to 1 year ]
Successful treatment of noninvasive mucosal tumors of the GI tract is defined by complete removal, with no residual tumor on follow-up.
Change History Complete list of historical versions of study NCT01750619 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 10, 2014)
  • 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
Original Secondary Outcome Measures
 (submitted: December 13, 2012)
  • Adverse event rate [ Time Frame: up to 1 month post procedure. ]
  • Rate of recurrence [ Time Frame: 6 months to 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Outcomes of the Endoscopic Resection of Premalignant and Malignant Gastrointestinal Lesions
Official Title Clinical Outcomes of the Endoscopic Resection of Premalignant and Malignant Gastrointestinal Lesions
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients referred to Interventional Endoscopy Services at CPMC for treatment of GI tract tumors.
Condition
  • Gastrointestinal Neoplasms
  • Benign Neoplasm of Intestinal Tract
Intervention Not Provided
Study 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 13, 2012)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jona C Bernabe 415-600-1151 Calitij@sutterhealth.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01750619
Other Study ID Numbers 2011.090
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Kenneth Binmoeller, California Pacific Medical Center Research Institute
Study Sponsor California Pacific Medical Center Research Institute
Collaborators Not Provided
Investigators
Principal Investigator: Kenneth F Binmoeller, M.D. California Pacific Medical Center
PRS Account California Pacific Medical Center Research Institute
Verification Date September 2018