Trials Sponsors Conditions Drugs Pricing

Conditions

Biopsy, Fine-Needle Cholangiocarcinoma Endoscopic Retrograde Cholangiopancreatography Klatskin Tumor

Outcome Measures

Primary Outcomes (1)

The diagnostic value of EUS-FNA/B versus ERCP with or without POCS-TB in diagnosing hilar cholangiocarcinoma
The diagnostic value was assessed by sensitivity, specificity, accuracy, and positive and negative predictive values.
2023-08-14 to 2027-08-01

Secondary Outcomes (18)

The incidence of complications
2023-08-14 to 2027-08-01
The cost-effectiveness ratio
2023-08-14 to 2027-08-01
The emergency readmission time
2023-08-14 to 2027-08-01
The proportion of tissue deemed adequate for cytological or histological analysis obtained by EUS-FNA/B and ERCP with or without POCS-TB.
2023-08-14 to 2027-08-01
The number of participants whose visual diagnosis by the new generation of Eye Max cholangioscopy was consistent with the pathological and final diagnoses, respectively.
2023-08-14 to 2027-08-01
+13 more secondary outcomes

Study Arms (2)

EUS-FNA/B group; ERCP with or without POCS-TB group

EUS-FNA/B group: Patients with suspected hilar cholangiocarcinoma who were considered suitable for obtaining histopathological diagnosis by EUS-FNA/B by experts

Diagnostic Test: The sampling method selected in patients with suspected hilar cholangiocarcinoma

ERCP with or without POCS-TB group

ERCP with or without POCS-TB group: Patients with suspected hilar cholangiocarcinoma who were considered suitable for obtaining histopathological diagnosis by ERCP with or without POCS-TB by experts

Diagnostic Test: The sampling method selected in patients with suspected hilar cholangiocarcinoma

Interventions

The sampling method selected in patients with suspected hilar cholangiocarcinomaDiagnostic test

The appropriate sampling approach was selected as EUS-FNA/B or ERCP with or without POCS-TB based on experts' overall evaluation. This study will compare the histopathological diagnosis of the selected sampling method with the final diagnosis.

ERCP with or without POCS-TB groupEUS-FNA/B group; ERCP with or without POCS-TB group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients with suspected hilar cholangiocarcinoma who were considered suitable for obtaining histopathological diagnosis by EUS-FNA/B or ERCP with or without POCS-TB by experts

You may qualify if:

≥ 18 years old;

Sponsors & Collaborators

Beijing Friendship Hospital
Othercollaborator
Sir Run Run Shaw Hospital
Othercollaborator
First Affiliated Hospital, Sun Yat-Sen University

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250063, China

MeSH Terms

Conditions

Klatskin TumorCholangiocarcinoma

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

Ning Zhong, MD
Qilu Hospital of Shandong University
PRINCIPAL INVESTIGATOR

Enrollment

200 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 13, 2023

First Posted

August 15, 2023

Study Start

August 14, 2023

Actual (reported)

Diagnostic Efficacy of EUS-FNA/B Versus ERCP With or Without POCS-TB in Patients With Suspected Hilar Cholangiocarcinoma

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (18)

Study Arms (2)

EUS-FNA/B group; ERCP with or without POCS-TB group

ERCP with or without POCS-TB group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (18)

Study Arms (2)

EUS-FNA/B group; ERCP with or without POCS-TB group

ERCP with or without POCS-TB group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations