Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06534229
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Impact of Preoperative Endoscopic Ultrasound-guided Fine-needle Aspiration in Cholangiocarcinoma Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Impact of Preoperative Endoscopic Ultrasound-guided Fine-needle Aspiration in Cholangiocarcinoma Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 05-25 cases per 100000 people in West-European countries and 16 cases per 100000 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 eg 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 segmentsThe 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
Currently surgical resection is the only potentially curative treatment The resectability of CCA depends on multiple factors eg 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 segmentsThe 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None