Sessile Serrated Adenoma/PolypsNCT03761667
Usefulness of NBI for Complete Endoscopic Resection of SSA/P
A study testing Endoscopy using Narrow band imaging in people with Sessile Serrated Adenoma/Polyps, run by Soonchunhyang University Hospital.
Trial summary
This study is a prospective randomized study to evaluate the role of NBI for improving complete resection rate of sessile serrated adenoma/polyp (SSA/P). The authors will enroll consecutive patients who underwent colon polypectomy for SSA/P during colonoscopy. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sessile Serrated Adenoma/Polyps
- What is being tested?
- Endoscopy using Narrow band imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- No sites listed yet
- Study dates
- 23 Dec 2015to 25 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Colonoscopy examinee with suspicious SSA/P
Who cannot join
- Poor bowel preparation (total Boston bowel preparation scale < 6 or any region score < 2)
- Inflammatory bowel disease
- failed cecal insertion of colonoscopy
- continuous taking anticoagulation or anti-platelet drugs until on the procedure day
About this study
Official title: Usefulness of Narrow Band Imaging (NBI) for Complete Endoscopic Resection of Sessile Serrated Adenoma/Polyp (SSA/P): NASA Study
This study is a prospective randomized study to evaluate the role of NBI for improving complete resection rate of sessile serrated adenoma/polyp (SSA/P). The authors will enroll consecutive patients who underwent colon polypectomy for SSA/P during colonoscopy. The authors will inspect resection margin of SSA/P using white light endosocpy (WLE) or NBI after randomization for the evaluation of remnant lesion. Additional resection will be performed for suspicious of remnant lesion, and then 4 biopsies from 4 quadrants of margin for evaluation of complete resection.
Read the detailed description
This study is a prospective randomized multi-center study to evaluate the role of NBI for improving complete resection rate of sessile serrated adenoma/polyp (SSA/P).
The authors will enroll consecutive patients who underwent colon polypectomy for suspicious SSA/P during colonoscopy.
All patients who undergo polypectomy will be enrolled, but excluded as follows; 1. poor bowel preparation according to Boston bowel preparation scale calculation, 2. inflammatory bowel disease, 3. failure of cecal insertion, 4. continuous anti-plate agents or anti-coagulation agents users.
First, the authors will inspect polyp using the arbitrary endoscopic criteria by inspection of white light endoscopy (WLE) and if that lesion is satisfied with 3 or more than 3 out of 5 categories (1. located in the right colon, 2. flat shape, 3. covered with mucus cap or debris, 4. 1 cm or larger than 1 cm in size, 5. varicose superficial vessel was seen on the surface after submucosal injection), endoscopic resection will be performed.
And then, the authors will inspect the resection margin carefully using NBI or WLE by pre-randomization before endoscopic resection. If the remnant tissue is detected, additional endoscopic resection will be performed.
ed margin as two groups (NBI inspection group and WLE inspection
And then, 4 biopsies from 4 quadrants of margin for evaluation of complete resection.
Primary end-point is comparing the rate of additional resection for remnant lesion, the SSA/P diagnosis rate of the remnant lesions after the additional resection, and the complete resection rate of the target lesion between two groups.
Secondary aim is evaluate the accuracy for SSA/P using arbitrary WLE criteria. For evaluation of the accuracy of arbitrary WLE criteria, the authors will compare the pathologic diagosis rate of SSA/P for each criterion, and calculate the sensitivity, the specificity, the positive predictive value, the negative predictive value, and the accuracy with area under curve of ROC.
The authors hypothesized complete resection rate of SSA/P as 90% in the NBI inspection group and 70% in the WLE inspection group based on previous studies including CARE study.
The sample size was calculated as 118 (each 59) patients of SSA/P. Study duration will be 2 years.
- Conditions
- Sessile Serrated Adenoma/Polyps
- Being tested
- Endoscopy using Narrow band imaging
- Medical subject headings
- Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopy using Narrow band imagingOther
Inspection of resection margin of SSA/P for the evaluation of complete resection or the presence of remnant lesion using NBI method
| Study group | Role | What they receive |
|---|---|---|
| NBI | Experimental | The group of NBI inspection on resection margin for surveillance of remnant tissue of SSA/P right after the endoscopic resection. If the remnant tissue is detected using NIB inspection, additional endoscopic resection should be performed. Receives: Other: Endoscopy using Narrow band imaging |
| White light endoscopy (WLE) | No intervention | The group of WLE inspection on resection margin for surveillance of remnant tissue of SSA/P right after the endoscopic resection. If the remnant tissue is detected using NIB inspection, additional endoscopic resection should be performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the detection rate of remnant lesion,
Comparing the detection rate of remnant SSA/P right after the endoscopic resection
Measured: 2 years after IRB
The diagnosis rate of SSA/P in the remnant tissue
Pathologic diagnosis rate of SSA/P after the additional endoscopic resection of the remnant tissue detected by NBI or WLE right after the endoscopic resection.
Measured: 2 years after IRB
Incomplete resection rate of SSA/P
Compare the incomplete resection rate of SSA/P using four directional biopsied on the resection margin after the endoscopic resection including additional resection
Measured: 2 years after IRB
Secondary outcomes (1)
Accuracy of arbitrary endoscopic criteria for SSA/P inspection by white light endoscopy
In this study, the authors made the arbitrary endoscopic criteria for suspicion of SSA/P by inspection of WLE.
Measured: 2 years after IRB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start23 Dec 2015
- Primary completion10 Nov 2018
- Study completion25 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sessile Serrated Adenoma/PolypsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soonchunhyang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun Gun, Kim. M.D., Ph.D., Soonchunhyang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761667
- Sponsor's protocol ID
- NASA
- Status last verified
- Nov 2018
- First submitted
- 29 Nov 2018
- Last updated
- 3 Dec 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Narrow Band Imaging (NBI) for Complete Endoscopic Resection of Sessile Serrated Adenoma/Polyp (SSA/P): NASA Study
- ClinicalTrials.gov ID
- NCT03761667
- Acronym / sponsor ID
- NASA
- Conditions
- Sessile Serrated Adenoma/Polyps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Soonchunhyang University HospitalUniversity, hospital or other
- Study start
- 23 Dec 2015 (actual)
- Primary completion
- 10 Nov 2018 (actual)
- Study completion
- 25 Nov 2018 (actual)
- First posted
- 3 Dec 2018 (actual)
- 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.
This study is a prospective randomized study to evaluate the role of NBI for improving complete resection rate of sessile serrated adenoma/polyp (SSA/P). The authors will enroll consecutive patients who underwent colon polypectomy for SSA/P during colonoscopy. The authors will inspect resection margin of SSA/P using white light endosocpy (WLE) or NBI after randomization for the evaluation of remnant lesion. Additional resection will be performed for suspicious of remnant lesion, and then 4 biopsies from 4 quadrants of margin for evaluation of complete resection.
Detailed description
This study is a prospective randomized multi-center study to evaluate the role of NBI for improving complete resection rate of sessile serrated adenoma/polyp (SSA/P).
The authors will enroll consecutive patients who underwent colon polypectomy for suspicious SSA/P during colonoscopy.
All patients who undergo polypectomy will be enrolled, but excluded as follows; 1. poor bowel preparation according to Boston bowel preparation scale calculation, 2. inflammatory bowel disease, 3. failure of cecal insertion, 4. continuous anti-plate agents or anti-coagulation agents users.
First, the authors will inspect polyp using the arbitrary endoscopic criteria by inspection of white light endoscopy (WLE) and if that lesion is satisfied with 3 or more than 3 out of 5 categories (1. located in the right colon, 2. flat shape, 3. covered with mucus cap or debris, 4. 1 cm or larger than 1 cm in size, 5. varicose superficial vessel was seen on the surface after submucosal injection), endoscopic resection will be performed.
And then, the authors will inspect the resection margin carefully using NBI or WLE by pre-randomization before endoscopic resection. If the remnant tissue is detected, additional endoscopic resection will be performed.
ed margin as two groups (NBI inspection group and WLE inspection
And then, 4 biopsies from 4 quadrants of margin for evaluation of complete resection.
Primary end-point is comparing the rate of additional resection for remnant lesion, the SSA/P diagnosis rate of the remnant lesions after the additional resection, and the complete resection rate of the target lesion between two groups.
Secondary aim is evaluate the accuracy for SSA/P using arbitrary WLE criteria. For evaluation of the accuracy of arbitrary WLE criteria, the authors will compare the pathologic diagosis rate of SSA/P for each criterion, and calculate the sensitivity, the specificity, the positive predictive value, the negative predictive value, and the accuracy with area under curve of ROC.
The authors hypothesized complete resection rate of SSA/P as 90% in the NBI inspection group and 70% in the WLE inspection group based on previous studies including CARE study.
The sample size was calculated as 118 (each 59) patients of SSA/P. Study duration will be 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NBI | Experimental | Other: Endoscopy using Narrow band imagingThe group of NBI inspection on resection margin for surveillance of remnant tissue of SSA/P right after the endoscopic resection. If the remnant tissue is detected using NIB inspection, additional endoscopic resection should be performed. |
| White light endoscopy (WLE) | No intervention | –The group of WLE inspection on resection margin for surveillance of remnant tissue of SSA/P right after the endoscopic resection. If the remnant tissue is detected using NIB inspection, additional endoscopic resection should be performed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Colonoscopy examinee with suspicious SSA/P
Key exclusion criteria (4 listed)
- Poor bowel preparation (total Boston bowel preparation scale < 6 or any region score < 2)
- Inflammatory bowel disease
- failed cecal insertion of colonoscopy
- continuous taking anticoagulation or anti-platelet drugs until on the procedure day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopy using Narrow band imagingInspection of resection margin of SSA/P for the evaluation of complete resection or the presence of remnant lesion using NBI method | Other | NBI |
Primary outcome
the detection rate of remnant lesion,
Time frame: 2 years after IRB
Comparing the detection rate of remnant SSA/P right after the endoscopic resection
The diagnosis rate of SSA/P in the remnant tissue
Time frame: 2 years after IRB
Pathologic diagnosis rate of SSA/P after the additional endoscopic resection of the remnant tissue detected by NBI or WLE right after the endoscopic resection.
Incomplete resection rate of SSA/P
Time frame: 2 years after IRB
Compare the incomplete resection rate of SSA/P using four directional biopsied on the resection margin after the endoscopic resection including additional resection
1 secondary outcome
Accuracy of arbitrary endoscopic criteria for SSA/P inspection by white light endoscopy
Time frame: 2 years after IRB
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2018.
Related trials for Sessile Serrated Adenoma/Polyps
Recruiting
Artificial Intelligence (AI) Assisted Real-time Adenoma Detection and Classification During Colonoscopies
Artificial Intelligence
Recruiting
Computer-Aided Water Exchange Colonoscopy With and Without Linked-Color Imaging for Detection of Clinically Significant Serrated Lesions
Sessile Colonic Polyp, Serrated Lesion
Active, not recruitingObservational study
Evaluation of 'WAYMED Endo CL CS' for Automated Detection and Diagnosis of Colorectal Adenoma and Non-Adenoma Lesions
Colorectal Adenoma, Sessile Serrated Lesion
RecruitingObservational study
AI in Predicting Polyp Pathology and Endoscopic Classification
Colorectal Polyps
Active, not recruitingObservational study
Molecular and Histological Characteristics of Serrated Lesions of the Colon
Colonic Neoplasms, Colorectal Cancer
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopy using Narrow band imaging in people with Sessile Serrated Adenoma/Polyps, run by Soonchunhyang University Hospital.
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 4 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: finished, as of the sponsor's last update on 3 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the detection rate of remnant lesion, (time frame: 2 years after IRB). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2018.