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Cholangiocarcinoma PatientsNCT06534229

Impact of Preoperative Endoscopic Ultrasound-guided Fine-needle Aspiration in Cholangiocarcinoma Patients

An observational study of Cholangiocarcinoma Patients, run by Asian Institute of Gastroenterology, India at 1 site in India.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Cholangiocarcinoma Patients
What is being tested?
Endoscopic ultrasound-guided fine-needle aspiration
How many people
100 participants
Where
1 siteIndia
Study dates
25 Aug 2024to 25 Aug 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • A patient who meets any of the following criteria will be excluded from inclusion:
  • History of treated CCA

Trial locations and contacts

1 site in 1 country.

Hardik Rughwani, MD contact

9426928600 ext. +91

hardik.hr@gmail.com

India1 site
  • AIG Hospitals

    Hyderabad, Telangana, 500032

Other trials in India

About this study

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.

Read the detailed description

Cholangiocarcinoma (CCA) is a rare malignancy originating from the bile duct epithelium. The incidence of CCA ranges from 0.5-2.5 cases per 100.000 people in West-European countries and 1.6 cases per 100.000 people in the United States of America. CCA is classified based on anatomical site and is divided into intrahepatic (iCCA), perihilar (pCCA) and distal (dCCA). Survival is limited, as CCA is often recognized in a relatively late stadium in which potential curative treatment is not an option anymore.

Currently, surgical resection is the only potentially curative treatment. The resectability of CCA depends on multiple factors: e.g. biliary extension, vascular involvement and presence of metastatic disease. Patients with metastatic disease, including both distant lymph nodes and metastases, are ineligible for surgical resection and palliative treatment should be initiated instead. Therefore, correct lymph node (N) staging is crucial. N staging depends on CCA subtype and differs between the 7th and 8th edition of The American Joint Committee on Cancer (AJCC) staging system. The most important difference between the two staging systems is the location of the regional (N1) versus distant lymph nodes (N2) in the 7th edition for pCCA and dCCA, while in the 8th edition distant N locations are considered M1 metastases and the number of lymph nodes determines the N stage. In both editions N locations in iCCA are subdivided for the left and right sided liver segments.The AJCC staging system is used to determine treatment and is correlated to survival. The 5-year survival for patients with regional or non-regional positive lymph nodes is worse compared to patients with negative lymph nodes.

To identify distant and lymph node metastases Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) is performed. However, it is difficult to accurately identify suspicious lymph nodes on both CT and MRI since sensitivity and specificity is 61% and 88% respectively for CT and 64% and 68% respectively for MRI. To assess lymph node staging more accurately, Endoscopic Ultrasound (EUS) with Fine Needle Aspiration (FNA) might be of added value. Only a few retrospective studies have described the yield of preoperative EUS for CCA. It is clear that EUS is an effective technique for lymph node staging for CCA, but data is inconsistent about the exact value and impact of EUS on clinical decision making.

Being tested
Endoscopic ultrasound-guided fine-needle aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endoscopic ultrasound-guided fine-needle aspirationDiagnostic test

    Endoscopic ultrasound-guided fine-needle aspiration for biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2024 - 2026

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2024
  2. Study start25 Aug 2024 (estimated)
  3. Primary completion25 Aug 2026 (estimated)
  4. Study completion25 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06534229
Sponsor's protocol ID
ROSC01
Status last verified
Jul 2024
First submitted
30 Jul 2024
Last updated
2 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cholangiocarcinoma Patients, run by Asian Institute of Gastroenterology, India at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hardik Rughwani, MD (9426928600 ext. +91, hardik.hr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lymph node detection by EUS (time frame: 2024 - 2026). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.

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