NCT00003085

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_2 pancreatic-cancer

Timeline
Completed

Started Sep 1996

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1996

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2000

Completed
4 years until next milestone

First Posted

Study publicly available on registry

June 16, 2004

Completed
Last Updated

May 22, 2014

Status Verified

May 1, 2014

Enrollment Period

3.8 years

First QC Date

November 1, 1999

Last Update Submit

May 20, 2014

Conditions

Pancreatic Cancer

Keywords

stage I pancreatic cancerstage II pancreatic cancer

Interventions

laparoscopyPROCEDURE
ultrasound imagingPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033-0800, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

LaparoscopyHigh-Energy Shock Waves

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeUltrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Dilip Parekh, MD

    University of Southern California

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
DIAGNOSTIC
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

June 16, 2004

Study Start

September 1, 1996

Primary Completion

July 1, 2000

Study Completion

July 1, 2000

Last Updated

May 22, 2014

Record last verified: 2014-05

Locations

US(1)