Spyglass+RFA Versus Cytobrush+RFA for Extrahepatic Cholangiocarcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-10-31

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.

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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.

Conditions

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Extrahepatic Cholangiocarcinoma Malignant Biliary Obstruction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

parallel

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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SpyGlass group

ERCP plus SpyGlass plus RFA group

Group Type EXPERIMENTAL

Spyglass + RFA

Intervention Type PROCEDURE

SpyGlass direct Vision guided RFA

Cytobrush Group

ERCP plus Cytobrush plus RFA group

Group Type ACTIVE_COMPARATOR

Cytobrush + RFA

Intervention Type PROCEDURE

After Cytobrush ,taking RFA through ERCP

Interventions

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Spyglass + RFA

SpyGlass direct Vision guided RFA

Intervention Type PROCEDURE

Cytobrush + RFA

After Cytobrush ,taking RFA through ERCP

Intervention Type PROCEDURE

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No