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NCT Number: NCT01750619

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

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.

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Key information

Conditions

Gastrointestinal Neoplasms Benign Neoplasm of Intestinal Tract Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Interventional Endoscopy Services

San Francisco, California, 94115, United States

Location status: Recruiting

Location contact

Jona C Bernabe

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Technical success.

    Time frame: 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 outcomes

  1. Short term recurrence rate

    Time frame: 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

  2. Long term recurrence rate

    Time frame: 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

  3. Adverse event rate

    Time frame: up to 1 month post procedure.

    Adverse events include infection, bleeding, perforation and death.

  4. Endoscopic en bloc resection rate

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Hayden Sampson

CONTACT

[email protected]

415-600-1151

Jona C Bernabe

CONTACT

[email protected]

415-600-1151

Sponsors and collaborators

Lead sponsor

California Pacific Medical Center Research Institute

Other

Registry information

Important dates

Study start
2011
Primary completion
2030
Study completion
2030
First posted
Dec 17, 2012
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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