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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCalifornia Pacific Medical Center Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients for whom endoscopic treatment was not performed.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

8,000 Participants
are grouped into 3 trial groups
Group A: Mucosal tumors of the colon
Group B: Nonampullary tumors of the duodenum
Group C: Ampullary tumors

Trial outcomes

Primary outcomes

1

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.

Time frame
1 day to 3 months

Secondary outcomes

1

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

Time frame
Less than 1 year
2

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

Time frame
Greater than 1 year
3

Adverse event rate

Adverse events include infection, bleeding, perforation and death.

Time frame
up to 1 month post procedure.
4

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

Time frame
Immediate

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.