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

March 8, 2022 updated by: Kenneth Binmoeller, California Pacific Medical Center Research Institute
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients referred to Interventional Endoscopy Services at CPMC for treatment of GI tract tumors.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients for whom endoscopic treatment was not performed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Less than 1 year
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
Greater than 1 year
Adverse event rate
Time Frame: up to 1 month post procedure.
Adverse events include infection, bleeding, perforation and death.
up to 1 month post procedure.
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
Immediate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

California Pacific Medical Center Research Institute

Investigators

  • Principal Investigator: Kenneth F Binmoeller, M.D., California Pacific Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

December 12, 2012

First Submitted That Met QC Criteria

December 13, 2012

First Posted (Estimate)

December 17, 2012

Study Record Updates

Last Update Posted (Actual)

March 10, 2022

Last Update Submitted That Met QC Criteria

March 8, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011.090

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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