Clinical trial · Interventional
Spyglass+RFA Versus Cytobrush+RFA for Extrahepatic Cholangiocarcinoma
Comparison of SpyGlass Guided RFA On The Same Stage Versus RFA After Cytobrush for Extrahepatic Cholangiocarcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extrahepatic Cholangiocarcinoma | Extrahepatic Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Malignant Biliary Obstruction | Cholangiocarcinoma | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytobrush + RFA | Procedure | — | UNRESOLVED |
| Spyglass + RFA | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SpyGlass group
- description
- ERCP plus SpyGlass plus RFA group
- interventionNames
- Procedure: Spyglass + RFA
- type
- ACTIVE_COMPARATOR
- label
- Cytobrush Group
- description
- ERCP plus Cytobrush plus RFA group
- interventionNames
- Procedure: Cytobrush + RFA
Primary outcomes (2)
- measure
- Pathological positive rate
- timeFrame
- 1 month
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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).
References
Publications (2)
- BACKGROUNDWeigand 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. PMID 33631748
- BACKGROUNDMinami 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. PMID 33921514