NCT05233293

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 14, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

August 15, 2023

Status Verified

August 1, 2023

Enrollment Period

2.7 years

First QC Date

January 14, 2022

Last Update Submit

August 13, 2023

Conditions

Extrahepatic CholangiocarcinomaMalignant Biliary Obstruction

Keywords

SpyglassRFAextrahepatic cholangiocarcinomaERCP

Outcome Measures

Primary Outcomes (2)

  • Pathological positive rate

    Malignant tumor diagnosis rate

    1 month

  • complications

    Incidence of Postoperative complications such as bleeding and infection

    1 month

Secondary Outcomes (2)

  • Number of sessions

    1 month

  • Procedure Time

    Intraoperative

Study Arms (2)

SpyGlass group

EXPERIMENTAL

ERCP plus SpyGlass plus RFA group

Procedure: Spyglass + RFA

Cytobrush Group

ACTIVE COMPARATOR

ERCP plus Cytobrush plus RFA group

Procedure: Cytobrush + RFA

Interventions

Spyglass + RFAPROCEDURE

SpyGlass direct Vision guided RFA

SpyGlass group
Cytobrush + RFAPROCEDURE

After Cytobrush ,taking RFA through ERCP

Cytobrush Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 31006, China

Location

Related Publications (2)

  • 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.

    PMID: 33631748BACKGROUND

  • 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.

    PMID: 33921514BACKGROUND

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Jianfeng Yang

    First People's Hospital of Hangzhou

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: parallel
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 14, 2022

First Posted

February 10, 2022

Study Start

January 1, 2021

Primary Completion

October 1, 2023

Study Completion

October 31, 2023

Last Updated

August 15, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)