Complication of Diagnostic ProcedurePIVINCT02162173
Dual Focus NBI and pCLE in FAP Related Duodenal Adenoma
A study testing Endoscopy in people with Complication of Diagnostic Procedure and Adverse Effect of Diagnostic Agents, Subsequent Encounter, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.
Trial summary
Background: Familial adenomatous polyposis (FAP) patients are at risk to develop periampullary and non-ampullary adenoma. Either a routine biopsy or an endoscopic removal of the lesion is generally required to identify the presence of adenoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complication of Diagnostic Procedure, Adverse Effect of Diagnostic Agents, Subsequent Encounter
- What is being tested?
- Endoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2012to Nov 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older with a history of FAP
- Patients who able to provide a written informed consent.
Who cannot join
- Evidence of coagulopathy (INR ≥ 1.5 and/or platelet < 80,000)
- Other bleeding tendency precluding biopsy
- Pregnancy
- allergy to fluorescein sodium
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Values of Dual Focus Narrow Band Imaging and Probe-based Confocal Laser Endomicroscopy in FAP Related Duodenal Adenoma
Background: Familial adenomatous polyposis (FAP) patients are at risk to develop periampullary and non-ampullary adenoma. Either a routine biopsy or an endoscopic removal of the lesion is generally required to identify the presence of adenoma. However, the risk of tissue sampling from the ampulla is high and non-ampullary polyps are sometimes numerous, therefore resecting all the lesions is time consuming. To support the PIVI (Preservation and Incorporation of Valuable endoscopic Innovations) initiative, a real-time diagnosis with NPV≥ 90% is required.
Objective: To evaluate the diagnostic values of duodenal adenoma by dual focus NBI (dNBI) and probe-based confocal endomicroscopy (pCLE) in FAP patients.
Read more
Design: Diagnostic study.
Setting: Single tertiary-care referral center.
Patients: Twenty-six patients with previously diagnosed with FAP.
Intervention: Surveillance EGD with dNBI and pCLE. A real time adenoma reading was done by two different endoscopists for each of the technique. Histology from the matched lesion was used as the gold standard.
Main outcome measurements: Sensitivity, specificity, positive predictive value (PPV), and accuracy. With the threshold for negative predictive value (NPV) ≥ 90%
Read the detailed description
Endoscopic procedure and criteria for adenoma diagnosis
- The endoscopic diagnostic criteria to distinguish between adenoma and non-adenoma were adopted from the previous studies by Uchiyama Y et al. in 2006. A real time adenoma diagnosis was made by the two independent endoscopists (BI and RP) who are experienced in dNBI and pCLE readings. Before entering into the study, they have experienced in reviewing the images obtained by dNBI and pCLE and published the related results elsewhere.
- During the study period, all 26 patients underwent the procedure under conscious sedation with intravenous midazolam and meperidine. Ten milligrams of hyoscine was given before the procedure to decrease intestinal peristalsis. At the beginning of the procedure, the first endoscopist (BI) used an end-viewing HWE attached with an endoscopic cap to examine the 1st and 2nd part of duodenum. The cap was used to facilitate a proper enface view of the ampulla and surrounding area. All applicable ampullary and non-ampullary (duodenal) polyps that larger than 1 millimeter would be recruited in this study. Then dNBI mode was switched on for a real-time diagnosis by the first endoscopist (BI). Subsequently, the second endoscopist (RP) who blinded to the NBI reading would be called from another room to perform pCLE examination. Two and a half milliliters of 10% fluorescein (Novartis Pharmaceutical Corporation, Bangkok, Thailand) was injected during pCLE evaluation. When there were more than one non-ampulary lesions, the first endoscopist only navigated the lesions to study under pCLE to the second endoscopist without telling the result of dNBI reading. Then, the matched polypectomy or biopsy was performed by the second endoscopist. The duration of the entire procedure and all complications related to the procedures were recorded.
Histological assessment - All polypectomy and biopsy specimens were immersed in formalin and sent for histological examination. The specimens were stained with hematoxylin and eosin (H\&E) and reviewed by an experienced GI pathologist (NW) blinded to the endoscopic diagnosis. The definite diagnosis was based on the Vienna classification for differentiation between adenoma and non-adenoma.
Statistical Analysis
-By using histology as the gold standard, the diagnostic values of dNBI and pCLE for ampullary and non-ampullary polyp interpretation were assessed for sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy. According to PIVI recommendation for colonic adenoma diagnosis20, we used the 90% NPV readings as our cut off. For numerical variables, the results were expressed as a mean ± SD, whereas other quantitative variables are expressed as percentages. SPSS version 17.0 (SPSS (Thailand) Co., Ltd., Bangkok, Thailand) for Windows systems was used for statistical analysis.
- Conditions
- Complication of Diagnostic Procedure, Adverse Effect of Diagnostic Agents, Subsequent Encounter
- Being tested
- Endoscopy
- Keywords
- Familial adenomatous polyposis syndrome, Non-ampullary polyp, Ampullary polyp, Narrow band imaging endoscopy, Confocal laser endomicroscopy
- Medical subject headings
- Adenomatous Polyposis Coli
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoscopyProcedure or surgery
Also called White light endoscopy, dual focus NBI endoscopy, probe-based confocal laser endomicroscopy, biopsy
Endoscopist performed white light endoscopy for polyp detection, then switch to dual focus NBI for characterization. Then probe-based confocal laser endomicroscopy was applied for characterization by another endoscopist independently and finally biopsy.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopy | Experimental | All patients underwent the same endoscopy. Receives: Procedure: Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
duodenal adenoma diagnosis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study startDec 2012
- Primary completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complication of Diagnostic ProcedureStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Chulalongkorn Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rapat Pittayanon, MD, King Chulalongkorn Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162173
- Sponsor's protocol ID
- RP007
- Acronym
- PIVI
- Status last verified
- Jun 2014
- First submitted
- 9 Jun 2014
- Last updated
- 12 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pittayanon R, Rerknimitr R, Imraporn B, Wisedopas N, Kullavanijaya P. Diagnostic values of dual focus narrow band imaging and probe-based confocal laser endomicroscopy in FAP-related duodenal adenoma. Endosc Int Open. 2015 Oct;3(5):E450-5. doi: 10.1055/s-0034-1392235. Epub 2015 Jun 23.
PubMed 26528500
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Values of Dual Focus Narrow Band Imaging and Probe-based Confocal Laser Endomicroscopy in FAP Related Duodenal Adenoma
- ClinicalTrials.gov ID
- NCT02162173
- Acronym / sponsor ID
- PIVI / RP007
- Conditions
- Complication of Diagnostic Procedure, Adverse Effect of Diagnostic Agents, Subsequent Encounter
- Keywords
- Familial adenomatous polyposis syndrome, Non-ampullary polyp, Ampullary polyp, Narrow band imaging endoscopy, Confocal laser endomicroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- King Chulalongkorn Memorial HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Nov 2013 (actual)
- First posted
- 12 Jun 2014 (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.
Background: Familial adenomatous polyposis (FAP) patients are at risk to develop periampullary and non-ampullary adenoma. Either a routine biopsy or an endoscopic removal of the lesion is generally required to identify the presence of adenoma. However, the risk of tissue sampling from the ampulla is high and non-ampullary polyps are sometimes numerous, therefore resecting all the lesions is time consuming. To support the PIVI (Preservation and Incorporation of Valuable endoscopic Innovations) initiative, a real-time diagnosis with NPV≥ 90% is required.
Objective: To evaluate the diagnostic values of duodenal adenoma by dual focus NBI (dNBI) and probe-based confocal endomicroscopy (pCLE) in FAP patients.
Design: Diagnostic study.
Setting: Single tertiary-care referral center.
Patients: Twenty-six patients with previously diagnosed with FAP.
Intervention: Surveillance EGD with dNBI and pCLE. A real time adenoma reading was done by two different endoscopists for each of the technique. Histology from the matched lesion was used as the gold standard.
Main outcome measurements: Sensitivity, specificity, positive predictive value (PPV), and accuracy. With the threshold for negative predictive value (NPV) ≥ 90%
Detailed description
Endoscopic procedure and criteria for adenoma diagnosis
- The endoscopic diagnostic criteria to distinguish between adenoma and non-adenoma were adopted from the previous studies by Uchiyama Y et al. in 2006. A real time adenoma diagnosis was made by the two independent endoscopists (BI and RP) who are experienced in dNBI and pCLE readings. Before entering into the study, they have experienced in reviewing the images obtained by dNBI and pCLE and published the related results elsewhere.
- During the study period, all 26 patients underwent the procedure under conscious sedation with intravenous midazolam and meperidine. Ten milligrams of hyoscine was given before the procedure to decrease intestinal peristalsis. At the beginning of the procedure, the first endoscopist (BI) used an end-viewing HWE attached with an endoscopic cap to examine the 1st and 2nd part of duodenum. The cap was used to facilitate a proper enface view of the ampulla and surrounding area. All applicable ampullary and non-ampullary (duodenal) polyps that larger than 1 millimeter would be recruited in this study. Then dNBI mode was switched on for a real-time diagnosis by the first endoscopist (BI). Subsequently, the second endoscopist (RP) who blinded to the NBI reading would be called from another room to perform pCLE examination. Two and a half milliliters of 10% fluorescein (Novartis Pharmaceutical Corporation, Bangkok, Thailand) was injected during pCLE evaluation. When there were more than one non-ampulary lesions, the first endoscopist only navigated the lesions to study under pCLE to the second endoscopist without telling the result of dNBI reading. Then, the matched polypectomy or biopsy was performed by the second endoscopist. The duration of the entire procedure and all complications related to the procedures were recorded.
Histological assessment - All polypectomy and biopsy specimens were immersed in formalin and sent for histological examination. The specimens were stained with hematoxylin and eosin (H\&E) and reviewed by an experienced GI pathologist (NW) blinded to the endoscopic diagnosis. The definite diagnosis was based on the Vienna classification for differentiation between adenoma and non-adenoma.
Statistical Analysis
-By using histology as the gold standard, the diagnostic values of dNBI and pCLE for ampullary and non-ampullary polyp interpretation were assessed for sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy. According to PIVI recommendation for colonic adenoma diagnosis20, we used the 90% NPV readings as our cut off. For numerical variables, the results were expressed as a mean ± SD, whereas other quantitative variables are expressed as percentages. SPSS version 17.0 (SPSS (Thailand) Co., Ltd., Bangkok, Thailand) for Windows systems was used for statistical analysis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopy | Experimental | Procedure: EndoscopyAll patients underwent the same endoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older with a history of FAP
- Patients who able to provide a written informed consent.
Key exclusion criteria (4 listed)
- Evidence of coagulopathy (INR ≥ 1.5 and/or platelet < 80,000)
- Other bleeding tendency precluding biopsy
- Pregnancy
- allergy to fluorescein sodium
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 |
|---|---|---|
| EndoscopyAlso: White light endoscopy, dual focus NBI endoscopy, probe-based confocal laser endomicroscopy, biopsyEndoscopist performed white light endoscopy for polyp detection, then switch to dual focus NBI for characterization. Then probe-based confocal laser endomicroscopy was applied for characterization by another endoscopist independently and finally biopsy. | Procedure or surgery | Endoscopy |
Primary outcome
duodenal adenoma diagnosis
Time frame: 1 year
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 12 Jun 2014.
- Derived from this study: PubMed 26528500Pittayanon R, Rerknimitr R, Imraporn B, Wisedopas N, Kullavanijaya P. Diagnostic values of dual focus narrow band imaging and probe-based confocal laser endomicroscopy in FAP-related duodenal adenoma. Endosc Int Open. 2015 Oct;3(5):E450-5. doi: 10.1055/s-0034-1392235. Epub 2015 Jun 23.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopy in people with Complication of Diagnostic Procedure and Adverse Effect of Diagnostic Agents, Subsequent Encounter, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.
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 2 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 12 Jun 2014. 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 Thailand. 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?
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?
duodenal adenoma diagnosis (time frame: 1 year). 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 NCT02162173, which also lists 1 linked publication.
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 12 Jun 2014.