Gastrointestinal NeoplasmsNCT01750619
Clinical Outcomes of the Endoscopic Resection of Premalignant and Malignant Gastrointestinal Lesions
An observational study of Gastrointestinal Neoplasms and Benign Neoplasm of Intestinal Tract, run by California Pacific Medical Center Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Neoplasms, Benign Neoplasm of Intestinal Tract
- How many people
- 8,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred to Interventional Endoscopy Services at CPMC for treatment of GI tract tumors.
Who may be able to join
- Patients age >18 years that have been referred for endoscopic treatment of GI lesions.
Who cannot join
- Patients for whom endoscopic treatment was not performed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Interventional Endoscopy Services
San Francisco, California, 94115
Jona C Bernabe, CalitiJ@sutterhealth.org
About this study
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.
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mucosal tumors of the colon | Patients who received endoscopic treatment for noninvasive mucosal tumors of the colon. | |
| Nonampullary tumors of the duodenum | Patients who received endoscopic treatment for noninvasive mucosal tumors of the duodenum. | |
| Ampullary tumors | Patients who received endoscopic treatment for noninvasive ampullary tumors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day to 3 months
Secondary outcomes (4)
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
Measured: Less than 1 year
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
Measured: Greater than 1 year
Adverse event rate
Adverse events include infection, bleeding, perforation and death.
Measured: up to 1 month post procedure.
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
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startJul 2011
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- California Pacific Medical Center Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth Binmoeller, California Pacific Medical Center Research Institute
- Investigators
- Kenneth F Binmoeller, M.D., Principal investigator, California Pacific Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750619
- Sponsor's protocol ID
- 2011.090
- Status last verified
- Mar 2026
- First submitted
- 12 Dec 2012
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Binmoeller KF, Hamerski CM, Shah JN, Bhat YM, Kane SD. Underwater EMR of adenomas of the appendiceal orifice (with video). Gastrointest Endosc. 2016 Mar;83(3):638-42. doi: 10.1016/j.gie.2015.08.079. Epub 2015 Sep 14.
PubMed 26375437Binmoeller KF, Hamerski CM, Shah JN, Bhat YM, Kane SD, Garcia-Kennedy R. Attempted underwater en bloc resection for large (2-4 cm) colorectal laterally spreading tumors (with video). Gastrointest Endosc. 2015 Mar;81(3):713-8. doi: 10.1016/j.gie.2014.10.044.
PubMed 25708759
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of the Endoscopic Resection of Premalignant and Malignant Gastrointestinal Lesions
- ClinicalTrials.gov ID
- NCT01750619
- Acronym / sponsor ID
- 2011.090
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- California Pacific Medical Center Research InstituteUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mucosal tumors of the colon | – | –Patients who received endoscopic treatment for noninvasive mucosal tumors of the colon. |
| Nonampullary tumors of the duodenum | – | –Patients who received endoscopic treatment for noninvasive mucosal tumors of the duodenum. |
| Ampullary tumors | – | –Patients who received endoscopic treatment for noninvasive ampullary tumors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to Interventional Endoscopy Services at CPMC for treatment of GI tract tumors.
Key inclusion criteria (1 listed)
- Patients age >18 years that have been referred for endoscopic treatment of GI lesions.
Key exclusion criteria (1 listed)
- Patients for whom endoscopic treatment was not performed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Short term recurrence rate
Time frame: Less than 1 year
Long term recurrence rate
Time frame: Greater than 1 year
Adverse event rate
Time frame: up to 1 month post procedure.
Endoscopic en bloc resection rate
Time frame: Immediate
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Derived from this study: PubMed 26375437Binmoeller KF, Hamerski CM, Shah JN, Bhat YM, Kane SD. Underwater EMR of adenomas of the appendiceal orifice (with video). Gastrointest Endosc. 2016 Mar;83(3):638-42. doi: 10.1016/j.gie.2015.08.079. Epub 2015 Sep 14.
- Derived from this study: PubMed 25708759Binmoeller KF, Hamerski CM, Shah JN, Bhat YM, Kane SD, Garcia-Kennedy R. Attempted underwater en bloc resection for large (2-4 cm) colorectal laterally spreading tumors (with video). Gastrointest Endosc. 2015 Mar;81(3):713-8. doi: 10.1016/j.gie.2014.10.044.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kenneth F Binmoeller, M.D. principal investigator
California Pacific Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Neoplasms and Benign Neoplasm of Intestinal Tract, run by California Pacific Medical Center Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jona C Bernabe (415-600-1151, jona.bernabe@sutterhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success. (time frame: 1 day to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01750619, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.