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

Recruiting

• Conditions: Benign Neoplasm of Intestinal Tract; Gastrointestinal Neoplasms

• Registration Number: NCT01750619
• Lead Sponsor: California Pacific Medical Center Research Institute

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 available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2012-12-12
• Study First Submitted QC: 2012-12-13
• Study First Posted: 2012-12-17
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-11
• Primary Completion: 2030-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Interventional Endoscopy Services; 🇺🇸 San Francisco, California, United States