Spyglass+RFA Versus Cytobrush+RFA for Extrahepatic Cholangiocarcinoma

Malignant Biliary Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05233293
• Other study ID #: 2022-01-10
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: October 31, 2023

Study information

• Verified date: August 2023
• Source: First People's Hospital of Hangzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• 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).

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Extrahepatic Cholangiocarcinoma
• Malignant Biliary Obstruction

Intervention

Procedure:
• Spyglass + RFA
SpyGlass direct Vision guided RFA
• Cytobrush + RFA
After Cytobrush ,taking RFA through ERCP

Locations

Country	Name	City	State
China	Hangzhou First People's Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First People's Hospital of Hangzhou

Country where clinical trial is conducted

China, 

References & Publications (2)

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

Outcome

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