Bile Duct Obstruction, ExtrahepaticNCT03708445
Development of a New Immunochemistry Method Using Antibodies of Proteins Related Bile Duct Cancer
A study testing Cytology staining in people with Bile Duct Obstruction, Extrahepatic, run by Gangnam Severance Hospital at 6 sites in South Korea.
Trial summary
The sensitivity of brushing cytology used to distinguish the cause of biliary strictures is low and clinical usefulness is not secured. The aim of this study was to develop a new differential staining method for cytology which is difficult to differentiate by the conventional staining method using biliary cancer… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Bile Duct Obstruction, Extrahepatic
- What is being tested?
- Cytology staining
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 1 Nov 2018to 22 Jan 2020
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with biliary cancer confirmed by imaging (CT, MRI, positron emission tomography)
- Patients with bile duct cancer diagnosed using brushing cytology by endoscopic retrograde pancreaticoduodenoscopy
- Patients who underwent surgical treatment with biliary cancer
- Patients with bile duct stenosis
Who cannot join
- Minors under the age of 19, vulnerable subjects such as illiteracy
- Necrotic specimens
- Samples with non-diagnostic cytology results and insufficient cells for further evaluation
- Samples classified as neoplastic (benign or other)
- Patient with cholangitis in the bile duct
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Pusan National University Hospital
Busan, Seo-gu, 49241
Soon Chun Hyang University Hospital, Cheonan
Cheonan, Namdong-gu, 31151
In Ha University Hospital
Incheon, Jung-gu, 22332
Gachon University Gil Medical Center
Incheon, Namdong-gu, 21565
CHA Bundang Medical Center
Seongnam, Bundang-gu, 13496
Gangnam Severance Hospital
Seoul, Gangnam-gu, 06229
About this study
Official title: Development of a New Immunochemistry Method Using Antibodies of Aminoacyl-tRNA Synthetases Group and Aminoacyl-transfer Ribonucleic Acid Synthetases-interacting Multifunctional protein2 Lacking Exon 2 in the Bile Duct Cancer Cell; Multicenter Study
The sensitivity of brushing cytology used to distinguish the cause of biliary strictures is low and clinical usefulness is not secured. The aim of this study was to develop a new differential staining method for cytology which is difficult to differentiate by the conventional staining method using biliary cancer related protein expressed only in bile duct cancer.
Read the detailed description
Hypothesis: The statistical significance of new staining method using aminoacyl-tRNA synthetases (ARSs) group in normal bile duct cells and the bile duct cancer cells collected by endoscopic retrograde pancreaticoduodenoscopy (ERCP) will be compared to prove the usefulness of the new staining method.
Clinical study design: The bile duct cytology will be obtained by brushing cytology using ERCP in patients with biliary stenosis. The expression of ARSs in the brushing cytology will be evaluated by new staining method and compare with the results of conventional cytology staining method including Papanicolaou staining. Immunofluorescence or immunohistochemistry staining will be performed to differentiate the presence of the tumor. The sensitivity and specificity of the new staining method will be compared with the conventional staining method and its usefulness be confirmed.
- Conditions
- Bile Duct Obstruction, Extrahepatic
- Being tested
- Cytology staining
- Keywords
- bile duct obstruction, extrahepatic, cytology, aminoacyl-tRNA synthetases
- Medical subject headings
- Cholestasis, Extrahepatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytology stainingDiagnostic test
Two staining will be performed in cytology specimens obtained from same patient. The cytology specimen will be obtained through brushing cytology using endoscopic retrograde cholangiopancreatography
- conventional cytology staining method
- new cytology staining method using antibody of aminoacyl-tRNA synthetases
| Study group | Role | What they receive |
|---|---|---|
| Bile duct stenosis | Experimental | This arm includes patients with bile duct stenosis. Endobiliary brushing cytology specimens will be obtained with endoscopic retrograde cholangiopancreatography (ERCP) of patients with bile duct stenosis. Cytology staining will be performed in the cytology specimens. Receives: Diagnostic Test: Cytology staining |
What is being measured
The primary outcome is the main question the study is designed to answer.
The usefulness of new staining method
The sensitivity, specificity, positive predictive value, negative predictive value and accuracy of new staining method will be compared with th conventional Pap staining of brushing cytology specimens.
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 posted17 Oct 2018
- Study start1 Nov 2018
- Primary completion22 Jan 2020
- Study completion22 Jan 2020
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 Bile Duct Obstruction, ExtrahepaticStudies 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
- Model description
- The conventional staining method and new staining method will be performed in cytology specimens obtained from same patient.
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Institute of Science and Technology
- Responsible party
- Principal investigator, Sung III Jang, Gangnam Severance Hospital
- Investigators
- Institutional Review Board, Study chair, Gangnam Severance Hospital, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03708445
- Sponsor's protocol ID
- 3-2016-0286
- Status last verified
- Feb 2020
- First submitted
- 14 Oct 2018
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share the following individual participant data with other researchers during study period. Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR), Analytic Code
Publications
Jang SI, Nahm JH, Kwon NH, Jeong S, Lee TH, Cho JH, Kwon CI, Kim DU, Kim JM, Cho HD, Lee HS, Kim S, Lee DK. Clinical utility of methionyl-tRNA synthetase 1 immunostaining in cytologic brushings of indeterminate biliary strictures: a multicenter prospective study. Gastrointest Endosc. 2021 Oct;94(4):733-741.e4. doi: 10.1016/j.gie.2021.04.026. Epub 2021 May 6.
PubMed 33965384
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a New Immunochemistry Method Using Antibodies of Aminoacyl-tRNA Synthetases Group and Aminoacyl-transfer Ribonucleic Acid Synthetases-interacting Multifunctional protein2 Lacking Exon 2 in the Bile Duct Cancer Cell; Multicenter Study
- ClinicalTrials.gov ID
- NCT03708445
- Acronym / sponsor ID
- 3-2016-0286
- Conditions
- Bile Duct Obstruction, Extrahepatic
- Keywords
- bile duct obstruction, extrahepatic, cytology, aminoacyl-tRNA synthetases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Collaborators
- Korea Institute of Science and Technology
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 22 Jan 2020 (actual)
- Study completion
- 22 Jan 2020 (actual)
- First posted
- 17 Oct 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.
The sensitivity of brushing cytology used to distinguish the cause of biliary strictures is low and clinical usefulness is not secured. The aim of this study was to develop a new differential staining method for cytology which is difficult to differentiate by the conventional staining method using biliary cancer related protein expressed only in bile duct cancer.
Detailed description
Hypothesis: The statistical significance of new staining method using aminoacyl-tRNA synthetases (ARSs) group in normal bile duct cells and the bile duct cancer cells collected by endoscopic retrograde pancreaticoduodenoscopy (ERCP) will be compared to prove the usefulness of the new staining method.
Clinical study design: The bile duct cytology will be obtained by brushing cytology using ERCP in patients with biliary stenosis. The expression of ARSs in the brushing cytology will be evaluated by new staining method and compare with the results of conventional cytology staining method including Papanicolaou staining. Immunofluorescence or immunohistochemistry staining will be performed to differentiate the presence of the tumor. The sensitivity and specificity of the new staining method will be compared with the conventional staining method and its usefulness be confirmed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The conventional staining method and new staining method will be performed in cytology specimens obtained from same patient.
| Arm | Type | Receives |
|---|---|---|
| Bile duct stenosis | Experimental | Diagnostic Test: Cytology stainingThis arm includes patients with bile duct stenosis. Endobiliary brushing cytology specimens will be obtained with endoscopic retrograde cholangiopancreatography (ERCP) of patients with bile duct stenosis. Cytology staining will be performed in the cytology specimens. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with biliary cancer confirmed by imaging (CT, MRI, positron emission tomography)
- Patients with bile duct cancer diagnosed using brushing cytology by endoscopic retrograde pancreaticoduodenoscopy
- Patients who underwent surgical treatment with biliary cancer
- Patients with bile duct stenosis
Key exclusion criteria (5 listed)
- Minors under the age of 19, vulnerable subjects such as illiteracy
- Necrotic specimens
- Samples with non-diagnostic cytology results and insufficient cells for further evaluation
- Samples classified as neoplastic (benign or other)
- Patient with cholangitis in the bile duct
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 |
|---|---|---|
| Cytology stainingTwo staining will be performed in cytology specimens obtained from same patient. The cytology specimen will be obtained through brushing cytology using endoscopic retrograde cholangiopancreatography 1. conventional cytology staining method 2. new cytology staining method using antibody of aminoacyl-tRNA synthetases | Diagnostic test | Bile duct stenosis |
Primary outcome
The usefulness of new staining method
Time frame: 1 year
The sensitivity, specificity, positive predictive value, negative predictive value and accuracy of new staining method will be compared with th conventional Pap staining of brushing cytology specimens.
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 5 Feb 2020.
- Derived from this study: PubMed 33965384Jang SI, Nahm JH, Kwon NH, Jeong S, Lee TH, Cho JH, Kwon CI, Kim DU, Kim JM, Cho HD, Lee HS, Kim S, Lee DK. Clinical utility of methionyl-tRNA synthetase 1 immunostaining in cytologic brushings of indeterminate biliary strictures: a multicenter prospective study. Gastrointest Endosc. 2021 Oct;94(4):733-741.e4. doi: 10.1016/j.gie.2021.04.026. Epub 2021 May 6.
- Individual participant dataSharing planned: Yes. We plan to share the following individual participant data with other researchers during study period. Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR), Analytic Code
Related trials for Bile Duct Obstruction, Extrahepatic
Recruiting
Repeated Endobiliary Radiofrequency Ablation Plus Durvalumab, Gemcitabine, and Cisplatin for Unresectable Extrahepatic Cholangiocarcinoma
Extrahepatic Cholangiocarcinoma
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.
Institutional Review Board study chair
Gangnam Severance Hospital, Yonsei University College of Medicine
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cytology staining in people with Bile Duct Obstruction, Extrahepatic, run by Gangnam Severance Hospital at 6 sites in South Korea.
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 4 inclusion and 5 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 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. 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?
The usefulness of new staining method (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 NCT03708445, 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 5 Feb 2020.