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.
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.
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.
- Conditions
- Cholangiocarcinoma Patients
- 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.
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.
- First posted2 Aug 2024
- Study start25 Aug 2024 (estimated)
- Primary completion25 Aug 2026 (estimated)
- Study completion25 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholangiocarcinoma PatientsStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Preoperative Endoscopic Ultrasound-guided Fine-needle Aspiration in Cholangiocarcinoma Patients
- ClinicalTrials.gov ID
- NCT06534229
- Acronym / sponsor ID
- ROSC01
- Conditions
- Cholangiocarcinoma Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 25 Aug 2024 (estimated)
- Primary completion
- 25 Aug 2026 (estimated)
- Study completion
- 25 Aug 2026 (estimated)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients are included retrospectively. Likely, a total of 100 patients are included.
Key inclusion criteria (3 listed)
- In order to be eligible to participate in this study, a patient must meet the following criteria:
- Suspected resectable CCA
- Patient underwent EUS preoperatively
Key exclusion criteria (2 listed)
- History of treated CCA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic ultrasound-guided fine-needle aspirationEndoscopic ultrasound-guided fine-needle aspiration for biopsy | Diagnostic test | – |
Primary outcome
Lymph node detection by EUS
Time frame: 2024 - 2026
Primary objective of this study is to evaluate the number of patients with positive LN detected by EUS and precluded from further surgical interventions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.