NCT06534229

Brief Summary

Primary objective of this study is to evaluate the number of patients with positive LN detected by EUS and precluded from further surgical interventions. Secondary objective of this study is to evaluate the EUS-related adverse events.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress90%
Aug 2024Aug 2026

First Submitted

Initial submission to the registry

July 30, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 2, 2024

Completed
23 days until next milestone

Study Start

First participant enrolled

August 25, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2026

Last Updated

August 2, 2024

Status Verified

July 1, 2024

Enrollment Period

2 years

First QC Date

July 30, 2024

Last Update Submit

July 30, 2024

Conditions

Cholangiocarcinoma Patients

Outcome Measures

Primary Outcomes (1)

  • Lymph node detection by EUS

    Primary objective of this study is to evaluate the number of patients with positive LN detected by EUS and precluded from further surgical interventions.

    2024 - 2026

Interventions

Endoscopic ultrasound-guided fine-needle aspirationDIAGNOSTIC_TEST

Endoscopic ultrasound-guided fine-needle aspiration for biopsy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All consecutive patients are included retrospectively. Likely, a total of 100 patients are included.

You may qualify if:

  • In order to be eligible to participate in this study, a patient must meet the following criteria:
  • Suspected resectable CCA
  • Patient underwent EUS preoperatively

You may not qualify if:

  • History of treated CCA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AIG Hospitals

Hyderabad, Telangana, 500032, India

Location

MeSH Terms

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Intervention Hierarchy (Ancestors)

Biopsy, Fine-NeedleBiopsy, NeedleBiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisImage-Guided BiopsySpecimen HandlingUltrasonography, InterventionalUltrasonographyDiagnostic ImagingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Central Study Contacts

Hardik Rughwani, MD

CONTACT

9426928600hardik.hr@gmail.com

Study Design

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

Study Record Dates

First Submitted

July 30, 2024

First Posted

August 2, 2024

Study Start

August 25, 2024

Primary Completion (Estimated)

August 25, 2026

Study Completion (Estimated)

August 25, 2026

Last Updated

August 2, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)