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Trial record 32 of 267 for:    Pancreatic Cancer AND Resectable

EUS vs. MDCT in Pancreatic Malignancy (EUSPACT)

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ClinicalTrials.gov Identifier: NCT02115022
Recruitment Status : Completed
First Posted : April 15, 2014
Last Update Posted : February 7, 2018
Sponsor:
Collaborators:
University of Medicine and Pharmacy Craiova
Iuliu Hatieganu University of Medicine and Pharmacy
Institutul Clinic Fundeni
Information provided by (Responsible Party):
Mihai Rimbas, Clinical Hospital Colentina

Brief Summary:

Accurate staging of patients with pancreatic cancer is critical to avoid the expense, morbidity, and mortality related to unnecessary surgery. While several tests are available for assessing such patients, consensus has not been achieved on the optimal approach. As a matter of fact, pancreatic cancer staging is discussed controversially due to conflicting evidence and certainly EUS has lost grounds due to improvements in CT technology. Thus, the role of EUS and EUS-guided FNA varies among treatment centers.

The present study is designed to better define the role of EUS in predicting resectability, as compared to high resolution cross-sectional imaging.


Condition or disease
Resectable Pancreatic Cancer

Detailed Description:

Registry procedures:

  • HIGH-RESOLUTION PANCREATIC PROTOCOL COMPUTED TOMOGRAPHY (CT) SCAN EXAMINATION: performed on at least 16-section multi-detector row (MD) CT and reviewed using multi-planar reconstructions, with images obtained following the oral administration of water and pancreatic protocol intravenous iopamidol, with images acquired in the pancreatic and portal venous phases of contrast enhancement, reconstructed as thin slice (at 1 mm - pancreatic phase or 2 mm - portal venous phase increments).
  • EUS EXAMINATION: performed within 2 weeks of the MDCT, aiming visualization of the pancreas, main surrounding vascular structures, celiac and mediastinal lymph nodes, liver and left adrenal gland, with EUS-FNA performed at the discretion of the investigator/examiner to confirm/exclude metastases and for the confirmation of malignancy in the primary tumor. Patients confirmed by EUS as having distant metastases are to be deferred from the planned surgical intervention.
  • SURGICAL INTERVENTION: aiming to provide curative intent (R0) resection.
  • HISTOPATHOLOGICAL POSTOPERATIVE STAGING: with evaluation of loco-regional invasiveness and degree of complete surgical resection (R0/R1).
  • FOLLOW-UP OF PATIENTS: with phone-calls on an every 6 month basis, for up to 2 years, retaining the following data: survival (or not), date of decease and its direct cause (if applicable), the presence of tumor recurrence (or not).

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Study Type : Observational [Patient Registry]
Actual Enrollment : 45 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Endoscopic UltraSound in Potentially Resectable PAncreatic Malignancy - Does it Bear the Weight of the Rapidly Evolving Technology of Computer Tomography?
Actual Study Start Date : July 2014
Actual Primary Completion Date : January 2018
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Potentially resectable pancreatic cancer
Patients with a confirmed pancreatic mass (suspected neoplastic) deemed resectable or borderline resectable on multislice (at least 16 simultaneously acquired slices) pancreatic protocol computed tomography (CT), fit and willing to undergo surgery with a curative (R0) intent.



Primary Outcome Measures :
  1. Staging capability of each study procedure [ Time Frame: Up to 2 weeks, depending on the time of the surgical intervention ]
    Each imaging test (MDCT and EUS) and findings at or after surgery are to be judged on their ability to provide descriptions of the primary tumor's size, location, relationship to vessels - using the terms abutment (≤180º of contact) and encasement (>180º of contact), vessel occlusion, variant vascular anatomy, a grade regarding local tumor resectability (resectable, borderline resectable, or locally advanced; R0 or R1 resection), and extent and location of extrapancreatic disease.


Secondary Outcome Measures :
  1. Side-effects related to the EUS examination [ Time Frame: Monitored for 24 hours after EUS ]
    Each patient will be monitored for 24 hours after the EUS examination to identify possible early complications of the procedure

  2. Patient survival time, and tumor recurrence-free survival [ Time Frame: Up to 2 years ]
    Each patient is going to be followed-up for up to 2 years after the surgical intervention an an every-6 month basis, in order to identify events such as death or tumor recurrence.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive patients with a confirmed pancreatic mass (suspected neoplastic) deemed resectable or borderline resectable on multislice (at least 16 simultaneously acquired slices) pancreatic protocol computed tomography (CT), fit and willing to undergo surgery with a curative (R0) intent.
Criteria

Inclusion Criteria:

  • adult (≥ 18 years of age) patients;
  • the presence of a confirmed pancreatic mass (suspected neoplastic) deemed resectable or borderline resectable on multislice (at least 16 simultaneously acquired slices) pancreatic protocol computed tomography (CT);
  • patients fit and willing to undergo surgery with a curative (R0) intent;
  • sign of the informed consent.

Exclusion Criteria:

  • the presence of significant co-morbidities that contraindicate pancreatic resection;
  • previous neo-adjuvant oncologic therapy;
  • distant metastases;
  • lack of discernment;
  • refusal to sign the informed consent..

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02115022


Locations
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Romania
Research Center in Gastroenterogy and Hepatology
Craiova, Dolj, Romania, 200638
University Military Hospital
Bucharest, Romania, 010825
Gastroenterology Department, Clinical Hospital Colentina
Bucharest, Romania, 020125
Fundeni Clinical Institute
Bucharest, Romania
Iuliu Hatieganu University of Medicine
Cluj Napoca, Romania
Sponsors and Collaborators
Clinical Hospital Colentina
University of Medicine and Pharmacy Craiova
Iuliu Hatieganu University of Medicine and Pharmacy
Institutul Clinic Fundeni
Investigators
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Principal Investigator: Mihai Rimbas, MD, PhD Clinical Hospital Colentina, Carol Davila University of Medicine and Pharmacy
Study Chair: Cristian R Baicus, Professor Clinical Hospital Colentina, Carol Davila University of Medicine and Pharmacy
Study Director: Adrian Saftoiu, Professor Craiova research Center in Gastroenterology and Hepatology, Craiova University of Medicine and Pharmacy

Additional Information:

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Responsible Party: Mihai Rimbas, MD, PhD, Assistant Professor, Clinical Hospital Colentina
ClinicalTrials.gov Identifier: NCT02115022     History of Changes
Other Study ID Numbers: Col-gastro 5
First Posted: April 15, 2014    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018
Keywords provided by Mihai Rimbas, Clinical Hospital Colentina:
pancreatic cancer
resectability
endosonography (EUS)
multidetection computer tomography (MDCT)
staging
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases