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

Gastrointestinal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01750619
• Other study ID #: 2011.090
• Status: Recruiting
• Start date: July 2011
• Est. completion date: December 2024

Study information

• Verified date: March 2022
• Source: California Pacific Medical Center Research Institute
• Contact: Jona C Bernabe
• Phone: 415-600-1151
• Email: Calitij[@]sutterhealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Benign Neoplasm of Intestinal Tract
• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Intestinal Neoplasms
• Neoplasms
• Precancerous Conditions

Locations

Country	Name	City	State
United States	Interventional Endoscopy Services	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
California Pacific Medical Center Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical success.	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	Short term recurrence rate	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
Secondary	Long term recurrence rate	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
Secondary	Adverse event rate	Adverse events include infection, bleeding, perforation and death.	up to 1 month post procedure.
Secondary	Endoscopic en bloc resection rate	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