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Spyglass+RFA Versus Cytobrush+RFA for Extrahepatic Cholangiocarcinoma

Primary Purpose

Extrahepatic Cholangiocarcinoma, Malignant Biliary Obstruction

Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Spyglass + RFA
Cytobrush + RFA
Sponsored by
First People's Hospital of Hangzhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extrahepatic Cholangiocarcinoma focused on measuring Spyglass, RFA, extrahepatic cholangiocarcinoma, ERCP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Hangzhou First People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SpyGlass group

Cytobrush Group

Arm Description

ERCP plus SpyGlass plus RFA group

ERCP plus Cytobrush plus RFA group

Outcomes

Primary Outcome Measures

Pathological positive rate
Malignant tumor diagnosis rate
complications
Incidence of Postoperative complications such as bleeding and infection

Secondary Outcome Measures

Number of sessions
Number of ERCP and RFA procedures
Procedure Time
Time spent for each surgery

Full Information

First Posted
January 14, 2022
Last Updated
August 13, 2023
Sponsor
First People's Hospital of Hangzhou
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1. Study Identification

Unique Protocol Identification Number
NCT05233293
Brief Title
Spyglass+RFA Versus Cytobrush+RFA for Extrahepatic Cholangiocarcinoma
Official Title
Comparison of SpyGlass Guided RFA On The Same Stage Versus RFA After Cytobrush for Extrahepatic Cholangiocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First People's Hospital of Hangzhou

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extrahepatic Cholangiocarcinoma, Malignant Biliary Obstruction
Keywords
Spyglass, RFA, extrahepatic cholangiocarcinoma, ERCP

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
parallel
Masking
ParticipantCare Provider
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SpyGlass group
Arm Type
Experimental
Arm Description
ERCP plus SpyGlass plus RFA group
Arm Title
Cytobrush Group
Arm Type
Active Comparator
Arm Description
ERCP plus Cytobrush plus RFA group
Intervention Type
Procedure
Intervention Name(s)
Spyglass + RFA
Intervention Description
SpyGlass direct Vision guided RFA
Intervention Type
Procedure
Intervention Name(s)
Cytobrush + RFA
Intervention Description
After Cytobrush ,taking RFA through ERCP
Primary Outcome Measure Information:
Title
Pathological positive rate
Description
Malignant tumor diagnosis rate
Time Frame
1 month
Title
complications
Description
Incidence of Postoperative complications such as bleeding and infection
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Number of sessions
Description
Number of ERCP and RFA procedures
Time Frame
1 month
Title
Procedure Time
Description
Time spent for each surgery
Time Frame
Intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianfeng Yang
Organizational Affiliation
First People's Hospital of Hangzhou
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hangzhou First People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
31006
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33631748
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.
Results Reference
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PubMed Identifier
33921514
Citation
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.
Results Reference
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Spyglass+RFA Versus Cytobrush+RFA for Extrahepatic Cholangiocarcinoma

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