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

NCT ID: NCT01750619

Last Updated: 2025-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2030-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastrointestinal Neoplasms Benign Neoplasm of Intestinal Tract

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mucosal tumors of the colon

Patients who received endoscopic treatment for noninvasive mucosal tumors of the colon.

No interventions assigned to this group

Nonampullary tumors of the duodenum

Patients who received endoscopic treatment for noninvasive mucosal tumors of the duodenum.

No interventions assigned to this group

Ampullary tumors

Patients who received endoscopic treatment for noninvasive ampullary tumors.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

California Pacific Medical Center Research Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kenneth Binmoeller

Interventional Endoscopy Services Program Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kenneth F Binmoeller, M.D.

Role: PRINCIPAL_INVESTIGATOR

California Pacific Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Interventional Endoscopy Services

San Francisco, California, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jona C Bernabe

Role: CONTACT

415-600-1151

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jona C Bernabe

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Binmoeller KF, Hamerski CM, Shah JN, Bhat YM, Kane SD. Underwater EMR of adenomas of the appendiceal orifice (with video). Gastrointest Endosc. 2016 Mar;83(3):638-42. doi: 10.1016/j.gie.2015.08.079. Epub 2015 Sep 14.

Reference Type DERIVED
PMID: 26375437 (View on PubMed)

Binmoeller KF, Hamerski CM, Shah JN, Bhat YM, Kane SD, Garcia-Kennedy R. Attempted underwater en bloc resection for large (2-4 cm) colorectal laterally spreading tumors (with video). Gastrointest Endosc. 2015 Mar;81(3):713-8. doi: 10.1016/j.gie.2014.10.044.

Reference Type DERIVED
PMID: 25708759 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2011.090

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Upper GI Outcomes Following EMR
NCT02305290 COMPLETED