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Laparoscopic Ultrasound in Diagnosing Patients With Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00003085
Recruitment Status : Terminated (Insufficient Accrual)
First Posted : June 16, 2004
Last Update Posted : May 22, 2014
Information provided by (Responsible Party):

November 1, 1999
June 16, 2004
May 22, 2014
September 1996
July 2000   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00003085 on ClinicalTrials.gov Archive Site
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Laparoscopic Ultrasound in Diagnosing Patients With Pancreatic Cancer
Minimal Access Surgery for Pancreas Cancer: A Phase II Trial Study I: Staging of Pancreas 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.

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.).

Phase 2
Primary Purpose: Diagnostic
Pancreatic Cancer
  • Procedure: laparoscopy
  • Procedure: ultrasound imaging
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
July 2000
July 2000   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS: Histological or radiological evidence of stage I or II pancreatic cancer No evidence of metastatic disease on CT scan

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No prohibitive anesthetic risk due to cardiac disease Pulmonary: No prohibitive anesthetic risk due to respiratory disease

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: No adhesions from previous surgery that preclude laparoscopy

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000065784 (3P-94-1A)
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University of Southern California
University of Southern California
National Cancer Institute (NCI)
Study Chair: Dilip Parekh, MD University of Southern California
University of Southern California
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP