Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003085
Status:
TERMINATED
Last Update Posted:
2014-05-22
First Post:
1999-11-01
Brief Title:
Laparoscopic Ultrasound in Diagnosing Patients With Pancreatic Cancer
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Minimal Access Surgery for Pancreas Cancer A Phase II Trial Study I Staging of Pancreas Cancer
Status:
TERMINATED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient Accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE New diagnostic procedures such as laparoscopic ultrasound may improve the ability to detect pancreatic cancer and determine the extent of disease
PURPOSE Phase II trial to study the effectiveness of laparoscopic ultrasound in diagnosing patients with stage I or stage II pancreatic cancer
PURPOSE Phase II trial to study the effectiveness of laparoscopic ultrasound in diagnosing patients with stage I or stage II pancreatic cancer
Detailed Description:
OBJECTIVES I Determine whether a comprehensive laparoscopic examination of the abdomen with laparoscopic ultrasonography improves staging of pancreatic cancer with respect to a better assessment compared to CT of the extent of localized extra pancreatic disease b vascular invasion c regional lymph node involvement and d metastatic deposits in liver parenchyma II Assess whether one of the newer minimally invasive imaging techniques laparoscopic ultrasonography predicts vascular invasion in pancreatic cancer III Develop an optimal cost effective strategy for assessing resectability in pancreatic cancer
OUTLINE Patients who have undergone routine clinical staging CT scan angiogram etc and who have been classified as potentially resectable undergo laparoscopy and laparoscopic ultrasound LLUS At the end of the LLUS based on the new findings patients are reclassified as either potentially resectable or potentially unresectable All patient then undergo definitive staging those who have metastasis to the liver that can be pathologically confirmed by biopsy at the time of the laparoscopy are classified as unresectable and do not undergo laparotomy all others undergo laparotomy and then are classified as resectable or unresectable If 8 or more patients are misclassified at the time of the LLUS then this study is terminated
PROJECTED ACCRUAL There will be 50 patients accrued into this study with 25 patients in each stage In order to accrue 50 patients approximately 70 patients will undergo the initial routine clinical staging CT scan angiogram etc
OUTLINE Patients who have undergone routine clinical staging CT scan angiogram etc and who have been classified as potentially resectable undergo laparoscopy and laparoscopic ultrasound LLUS At the end of the LLUS based on the new findings patients are reclassified as either potentially resectable or potentially unresectable All patient then undergo definitive staging those who have metastasis to the liver that can be pathologically confirmed by biopsy at the time of the laparoscopy are classified as unresectable and do not undergo laparotomy all others undergo laparotomy and then are classified as resectable or unresectable If 8 or more patients are misclassified at the time of the LLUS then this study is terminated
PROJECTED ACCRUAL There will be 50 patients accrued into this study with 25 patients in each stage In order to accrue 50 patients approximately 70 patients will undergo the initial routine clinical staging CT scan angiogram etc
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V97-1339 | None | None | None |
| LAC-USC-3P941A | None | None | None |