Malignant Biliary Obstruction Clinical Trial
Official title:
Comparison of SpyGlass Guided RFA On The Same Stage Versus RFA After Cytobrush for Extrahepatic Cholangiocarcinoma
Verified date | August 2023 |
Source | First People's Hospital of Hangzhou |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 200 |
Est. completion date | October 31, 2023 |
Est. primary completion date | October 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
China | Hangzhou First People's Hospital | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
First People's Hospital of Hangzhou |
China,
Minami 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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pathological positive rate | Malignant tumor diagnosis rate | 1 month | |
Primary | complications | Incidence of Postoperative complications such as bleeding and infection | 1 month | |
Secondary | Number of sessions | Number of ERCP and RFA procedures | 1 month | |
Secondary | Procedure Time | Time spent for each surgery | Intraoperative |
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