Laparoscopic Ultrasound in Diagnosing Patients With Pancreatic Cancer
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.
|Pancreatic Cancer||Procedure: laparoscopy Procedure: ultrasound imaging||Phase 2|
|Study Design:||Primary Purpose: Diagnostic|
|Official Title:||Minimal Access Surgery for Pancreas Cancer: A Phase II Trial Study I: Staging of Pancreas Cancer|
|Study Start Date:||September 1996|
|Study Completion Date:||July 2000|
|Primary Completion Date:||July 2000 (Final data collection date for primary outcome measure)|
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 (L+LUS). At the end of the L+LUS, 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 L+LUS, 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.).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003085
|United States, California|
|USC/Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033-0800|
|Study Chair:||Dilip Parekh, MD||University of Southern California|