Extrahepatic CholangiocarcinomaNCT05233293
Spyglass+RFA Versus Cytobrush+RFA for Extrahepatic Cholangiocarcinoma
A study testing Spyglass + RFA and Cytobrush + RFA in people with Extrahepatic Cholangiocarcinoma and Malignant Biliary Obstruction, run by First People's Hospital of Hangzhou at 1 site in China.
Trial summary
With the development of endoscopic technology, endoscopic retrograde cholangiopancreatography (ERCP) has been widely used in the diagnosis and treatment of extrahepatic cholangiocarcinoma.In patients with extrahepatic cholangiocarcinoma, cytological brushing performed concurrently with ERCP had a lower pathologically… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extrahepatic Cholangiocarcinoma, Malignant Biliary Obstruction
- What is being tested?
- Spyglass + RFA and Cytobrush + RFA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Oct 2023
- 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
- Age >18 years ;
- Patients with high suspicion of extrahepatic cholangiocarcinoma such as unexplained bile duct stenosis or elevated CA19-9 were found according to relevant imaging studies or symptoms;
- Willing to abide by the research procedures and sign the informed consent.
Who cannot join
- Myocardial infarction within 3 months;
- Renal insufficiency (Scr>177 umol/L);
- Serious cardiovascular and cerebrovascular or respiratory diseases before surgery;
- Preoperative shock manifestations, such as hypotension ( Systolic blood pressure <90mmHg) or increased heart rate (>120 beats/min);
- Pregnancy and lactation;
- Allergic to NSAIDs; Other clinical observation trials or those who have participated in other clinical trials within 60 days;
- Cases deemed inappropriate by the investigator (such as those with clear contraindications to ERCP).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of SpyGlass Guided RFA On The Same Stage Versus RFA After Cytobrush for Extrahepatic Cholangiocarcinoma
With the development of endoscopic technology, endoscopic retrograde cholangiopancreatography (ERCP) has been widely used in the diagnosis and treatment of extrahepatic cholangiocarcinoma.In patients with extrahepatic cholangiocarcinoma, cytological brushing performed concurrently with ERCP had a lower pathologically positive rate and increased the times of ERCPs, increased the risk of postoperative complications at the same time.The present study aims to compare the efficacy and safety outcomes of Spyglass+RFA Versus Cytobrush+RFA for Extrahepatic Cholangiocarcinoma.
Read the detailed description
Endoscopic retrograde cholangiopancreatography (ERCP) has been used as the primary method for the diagnosis of biliary strictures and the treatment of extrahepatic cholangiocarcinoma. However, the accurate visual diagnosis of malignant biliary strictures and assessment of the extent of a lesion are not possible by ERCP, and treatment of extrahepatic cholangiocarcinoma by ERCP procedures is sometimes difficult. In patients with extrahepatic cholangiocarcinoma, cytological brushing performed concurrently with ERCP had a lower pathologically positive rate and increased the times of ERCPs, increased the risk of postoperative complications at the same time. Spyglass enables direct visualization of the biliary tract and the sampling of suspicious lesions, together with radiofrequency ablation.Endoscopic radiofrequency ablation (RFA) is an emerging technique for the palliation of inoperable malignant biliary strictures (MBSs). In a dozen published studies, this novel approach has shown better safety and feasibility, as well as improvement in overall survival (OS). The present study aims to compare the efficacy and safety outcomes of Spyglass+RFA Versus Cytobrush+RFA for Extrahepatic Cholangiocarcinoma.
- Being tested
- Spyglass + RFA, Cytobrush + RFA
- Keywords
- Spyglass, RFA, extrahepatic cholangiocarcinoma, ERCP
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spyglass + RFAProcedure or surgery
SpyGlass direct Vision guided RFA
Cytobrush + RFAProcedure or surgery
After Cytobrush ,taking RFA through ERCP
| Study group | Role | What they receive |
|---|---|---|
| SpyGlass group | Experimental | ERCP plus SpyGlass plus RFA group Receives: Procedure: Spyglass + RFA |
| Cytobrush Group | Active comparator | ERCP plus Cytobrush plus RFA group Receives: Procedure: Cytobrush + RFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological positive rate
Malignant tumor diagnosis rate
Measured: 1 month
complications
Incidence of Postoperative complications such as bleeding and infection
Measured: 1 month
Secondary outcomes (2)
Number of sessions
Number of ERCP and RFA procedures
Measured: 1 month
Procedure Time
Time spent for each surgery
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start1 Jan 2021
- Primary completion1 Oct 2023 (estimated)
- Study completion31 Oct 2023 (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 Extrahepatic CholangiocarcinomaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- parallel
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianfeng Yang, First People's Hospital of Hangzhou
- Investigators
- Jianfeng Yang, Principal investigator, First People's Hospital of Hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233293
- Sponsor's protocol ID
- 2022-01-10
- Status last verified
- Aug 2023
- First submitted
- 14 Jan 2022
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weigand K, Kuchle M, Zuber-Jerger I, Muller M, Kandulski A. Diagnostic Accuracy and Therapeutic Efficacy of Digital Single-Operator Cholangioscopy for Biliary Lesions and Stenosis. Digestion. 2021;102(5):776-782. doi: 10.1159/000513713. Epub 2021 Feb 25.
PubMed 33631748Minami H, Mukai S, Sofuni A, Tsuchiya T, Ishii K, Tanaka R, Tonozuka R, Honjo M, Yamamoto K, Nagai K, Matsunami Y, Asai Y, Kurosawa T, Kojima H, Homma T, Itoi T. Clinical Outcomes of Digital Cholangioscopy-Guided Procedures for the Diagnosis of Biliary Strictures and Treatment of Difficult Bile Duct Stones: A Single-Center Large Cohort Study. J Clin Med. 2021 Apr 12;10(8):1638. doi: 10.3390/jcm10081638.
PubMed 33921514
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of SpyGlass Guided RFA On The Same Stage Versus RFA After Cytobrush for Extrahepatic Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT05233293
- Acronym / sponsor ID
- 2022-01-10
- Keywords
- Spyglass, RFA, extrahepatic cholangiocarcinoma, ERCP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 10 Feb 2022 (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.
With the development of endoscopic technology, endoscopic retrograde cholangiopancreatography (ERCP) has been widely used in the diagnosis and treatment of extrahepatic cholangiocarcinoma.In patients with extrahepatic cholangiocarcinoma, cytological brushing performed concurrently with ERCP had a lower pathologically positive rate and increased the times of ERCPs, increased the risk of postoperative complications at the same time.The present study aims to compare the efficacy and safety outcomes of Spyglass+RFA Versus Cytobrush+RFA for Extrahepatic Cholangiocarcinoma.
Detailed description
Endoscopic retrograde cholangiopancreatography (ERCP) has been used as the primary method for the diagnosis of biliary strictures and the treatment of extrahepatic cholangiocarcinoma. However, the accurate visual diagnosis of malignant biliary strictures and assessment of the extent of a lesion are not possible by ERCP, and treatment of extrahepatic cholangiocarcinoma by ERCP procedures is sometimes difficult. In patients with extrahepatic cholangiocarcinoma, cytological brushing performed concurrently with ERCP had a lower pathologically positive rate and increased the times of ERCPs, increased the risk of postoperative complications at the same time. Spyglass enables direct visualization of the biliary tract and the sampling of suspicious lesions, together with radiofrequency ablation.Endoscopic radiofrequency ablation (RFA) is an emerging technique for the palliation of inoperable malignant biliary strictures (MBSs). In a dozen published studies, this novel approach has shown better safety and feasibility, as well as improvement in overall survival (OS). The present study aims to compare the efficacy and safety outcomes of Spyglass+RFA Versus Cytobrush+RFA for Extrahepatic Cholangiocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- parallel
| Arm | Type | Receives |
|---|---|---|
| SpyGlass group | Experimental | Procedure: Spyglass + RFAERCP plus SpyGlass plus RFA group |
| Cytobrush Group | Active comparator | Procedure: Cytobrush + RFAERCP plus Cytobrush plus RFA group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years ;
- Patients with high suspicion of extrahepatic cholangiocarcinoma such as unexplained bile duct stenosis or elevated CA19-9 were found according to relevant imaging studies or symptoms;
- Willing to abide by the research procedures and sign the informed consent.
Key exclusion criteria (7 listed)
- Myocardial infarction within 3 months;
- Renal insufficiency (Scr>177 umol/L);
- Serious cardiovascular and cerebrovascular or respiratory diseases before surgery;
- Preoperative shock manifestations, such as hypotension ( Systolic blood pressure <90mmHg) or increased heart rate (>120 beats/min);
- Pregnancy and lactation;
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 |
|---|---|---|
| Spyglass + RFASpyGlass direct Vision guided RFA | Procedure or surgery | SpyGlass group |
| Cytobrush + RFAAfter Cytobrush ,taking RFA through ERCP | Procedure or surgery | Cytobrush Group |
Primary outcome
Pathological positive rate
Time frame: 1 month
Malignant tumor diagnosis rate
complications
Time frame: 1 month
Incidence of Postoperative complications such as bleeding and infection
2 secondary outcomes
Number of sessions
Time frame: 1 month
Procedure Time
Time frame: Intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Background: PubMed 33631748Weigand K, Kuchle M, Zuber-Jerger I, Muller M, Kandulski A. Diagnostic Accuracy and Therapeutic Efficacy of Digital Single-Operator Cholangioscopy for Biliary Lesions and Stenosis. Digestion. 2021;102(5):776-782. doi: 10.1159/000513713. Epub 2021 Feb 25.
- Background: PubMed 33921514Minami H, Mukai S, Sofuni A, Tsuchiya T, Ishii K, Tanaka R, Tonozuka R, Honjo M, Yamamoto K, Nagai K, Matsunami Y, Asai Y, Kurosawa T, Kojima H, Homma T, Itoi T. Clinical Outcomes of Digital Cholangioscopy-Guided Procedures for the Diagnosis of Biliary Strictures and Treatment of Difficult Bile Duct Stones: A Single-Center Large Cohort Study. J Clin Med. 2021 Apr 12;10(8):1638. doi: 10.3390/jcm10081638.
- Individual participant dataSharing planned: No
Related trials for Extrahepatic Cholangiocarcinoma
Recruiting
Photodynamic Therapy Combined With a Self-expandable Radioactive Particle-loaded Biliary Stent for Unresectable Extrahepatic Cholangiocarcinoma
Extrahepatic Cholangiocarcinoma
RecruitingPhase 3
Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
Biliary Tract Cancer
RecruitingPhase 2
Durvalumab + Intraductal Radiofrequency Ablation (ID-RFA) in Extra- and Intrahepatic Cholangiocarcinoma
Extrahepatic Cholangiocarcinoma, Unresectable Perihilar or Ductal CCA
RecruitingPhase 3
A Study to Select a Dose Regimen (Part A) and to Investigate Overall Survival (Part B) With Nanvuranlat Compared With Physician's Best Choice in Participants Aged 18 Years or Older With Biliary Tract Cancer
Advanced Biliary Tract Cancer, Biliary Tract Cancer (BTC)
Active, not recruiting
Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET in Diagnosing Patients With CEA Positive Cancer
Breast Cancer, Colon 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.
Jianfeng Yang principal investigator
First People's Hospital of Hangzhou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spyglass + RFA and Cytobrush + RFA in people with Extrahepatic Cholangiocarcinoma and Malignant Biliary Obstruction, run by First People's Hospital of Hangzhou at 1 site in China.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 15 Aug 2023. 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 China. 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?
Results are not available in the source record.
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?
Pathological positive rate (time frame: 1 month). The study lists 2 primary outcomes in all. 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 NCT05233293, 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 15 Aug 2023.