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Minimal Access Surgery for Pancreas Cancer: A Phase II Trial Study I: Staging of Pancreas Cancer

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

Minimal Access Surgery for Pancreas Cancer: A Phase II Trial Study I: Staging of Pancreas 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.).

Inclusion Criteria

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

Type of Study:


Study Design:

Primary Purpose: Diagnostic

Principal Investigator

Dilip Parekh, MD

Investigator Role:

Study Chair

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center


United States: Federal Government

Study ID:

CDR0000065784 (3P-94-1A)



Start Date:

September 1996

Completion Date:

July 2000

Related Keywords:

  • Pancreatic Cancer
  • stage I pancreatic cancer
  • stage II pancreatic cancer
  • Pancreatic Neoplasms



USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800