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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01750619

Enrollment

8000

Registered

2012-12-17

Start date

2011-07-01

Completion date

2030-12-01

Last updated

2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Neoplasm of Intestinal Tract, Gastrointestinal Neoplasms

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Technical success.	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

Measure	Time frame	Description
Short term recurrence rate	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	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	up to 1 month post procedure.	Adverse events include infection, bleeding, perforation and death.
Endoscopic en bloc resection rate	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

Countries

United States

Contacts

CONTACTJona C Bernabe

jona.bernabe@sutterhealth.org415-600-1151

CONTACTHayden Sampson

Hayden.sampson@sutterhealth.org415-600-1151

PRINCIPAL_INVESTIGATORKenneth F Binmoeller, M.D.

California Pacific Medical Center

Outcome results