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| Name | Class |
|---|---|
| University of Medicine and Pharmacy Craiova | OTHER |
| Iuliu Hatieganu University of Medicine and Pharmacy | OTHER |
| Institutul Clinic Fundeni | OTHER |
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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.
Registry procedures:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Staging capability of each study procedure | 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. | Up to 2 weeks, depending on the time of the surgical intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Side-effects related to the EUS examination | Each patient will be monitored for 24 hours after the EUS examination to identify possible early complications of the procedure | Monitored for 24 hours after EUS |
| Patient survival time, and tumor recurrence-free survival |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Mihai Rimbas, MD, PhD | Clinical Hospital Colentina, Carol Davila University of Medicine and Pharmacy | Principal Investigator |
| Cristian R Baicus, Professor | Clinical Hospital Colentina, Carol Davila University of Medicine and Pharmacy | Study Chair |
| Adrian Saftoiu, Professor | Craiova research Center in Gastroenterology and Hepatology, Craiova University of Medicine and Pharmacy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Center in Gastroenterogy and Hepatology | Craiova | Dolj | 200638 | Romania | ||
| University Military Hospital |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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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. |
| Up to 2 years |
| Bucharest |
| 010825 |
| Romania |
| Gastroenterology Department, Clinical Hospital Colentina | Bucharest | 020125 | Romania |
| Fundeni Clinical Institute | Bucharest | Romania |
| Iuliu Hatieganu University of Medicine | Cluj-Napoca | Romania |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |