Spyglass+RFA Versus Cytobrush+RFA for Extrahepatic Cholangiocarcinoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of SpyGlass Guided RFA On The Same Stage Versus RFA After Cytobrush for Extrahepatic Cholangiocarcinoma

Conditions
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Extrahepatic Cholangiocarcinoma, Malignant Biliary Obstruction

Intervention / Treatment
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* Procedure: Spyglass + RFA
* Procedure: Cytobrush + RFA


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: parallel
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SpyGlass group<br>ERCP plus SpyGlass plus RFA group | Procedure: Spyglass + RFA<br>* SpyGlass direct Vision guided RFA<br>|
| Active Comparator: Cytobrush Group<br>ERCP plus Cytobrush plus RFA group | Procedure: Cytobrush + RFA<br>* After Cytobrush ,taking RFA through ERCP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological positive rate | Malignant tumor diagnosis rate | 1 month | 
| complications | Incidence of Postoperative complications such as bleeding and infection | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of sessions | Number of ERCP and RFA procedures | 1 month | 
| Procedure Time | Time spent for each surgery | Intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spyglass, RFA, extrahepatic cholangiocarcinoma, ERCP