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Laparoscopic Ultrasound in Diagnosing Patients With Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
laparoscopy
ultrasound imaging
Sponsored by
University of Southern California
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pancreatic Cancer focused on measuring stage I pancreatic cancer, stage II pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • USC/Norris Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
May 20, 2014
Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003085
Brief Title
Laparoscopic Ultrasound in Diagnosing Patients With Pancreatic Cancer
Official Title
Minimal Access Surgery for Pancreas Cancer: A Phase II Trial Study I: Staging of Pancreas Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Why Stopped
Insufficient Accrual
Study Start Date
September 1996 (undefined)
Primary Completion Date
July 2000 (Actual)
Study Completion Date
July 2000 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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 (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.).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
stage I pancreatic cancer, stage II pancreatic cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
laparoscopy
Intervention Type
Procedure
Intervention Name(s)
ultrasound imaging

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilip Parekh, MD
Organizational Affiliation
University of Southern California
Official's Role
Study Chair
Facility Information:
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-0800
Country
United States

12. IPD Sharing Statement

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Laparoscopic Ultrasound in Diagnosing Patients With Pancreatic Cancer

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