Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Radical surgical resection is the only curative treatment option for pancreatic cancer, but borderline resectable tumors have a high probability of incomplete exeresis. Although neoadjuvant therapy can improve the chances of complete exeresis, not all patients respond as expected.
Pancreatic cancer is an important cause of cancer-related death worldwide. Radical surgical resection still is the only curative treatment option today, but not all tumors are considered resectable. Among resectable tumors, some are deemed borderline and have a high probability of incomplete exeresis. Neoadjuvant therapy (NAT) can be a game-changer for borderline cases, and there is a lack of evidence on the predictive factors associated with resectability after neoadjuvant treatment.
This study aims to assess the prognostic factors for resectability and survival after NAT in type A borderline resectable pancreatic ductal adenocarcinoma patients.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exploratory Surgery with Resection | Type A BR-PDAC patients that underwent surgical exploration after neoadjuvant therapy and had their tumors resected. |
| |
| Exploratory Surgery without Resection | Type A BR-PDAC patients that underwent surgical exploration after neoadjuvant therapy and did not have their tumors resected. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resection | Procedure | Type A BR-PDAC patients who had a favorable tumor/vascular structures relationship confirmed during surgical exploration underwent resection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of type A BR-PDAC patients who, after receiving NAT (≥3 cycles), undergo resection. | NAT was administered up to 6 cycles, and cycles were administered every 2 weeks. The minimum time interval between the last NAT session and surgery was 4 weeks. | From 6 weeks until the end of the observation period (December 2019) or death (whichever occurs first) |
| The evolution of the plasmatic levels of CA 19-9 from starting NAT until the surgical exploration. | NAT was administered up to 6 cycles, and cycles were administered every 2 weeks. The minimum time interval between the last NAT session and surgery was 4 weeks. | Up to 16 weeks |
| The evolution of the degree of vascular involvement in 64-MDCT scans from starting NAT until the surgical exploration. | We will evaluate the tumor's anatomical relationship with neighboring vascular structures before and after NAT, measured with 64-MDCT (multidetector computerized tomography) scans. NAT was administered up to 6 cycles, and cycles were administered every 2 weeks. The minimum time interval between the last NAT session and surgery was 4 weeks. | Up to 16 weeks |
| Overall survival | Time until death (from any cause) | From starting NAT until the end of the observation period (December 2019) or death (whichever occurs first). |
| The evolution of the plasmatic levels of CA 19-9 | From starting NAT until end of the observation period (December 2019) or death (whichever occurs first). | |
| The evolution of the degree of vascular involvement in 64-MDCT scans | The tumor's anatomical relationship with neighboring vascular structures; measured with 64-MDCT scans. |
| Measure | Description | Time Frame |
|---|---|---|
| The number (percentage) of deaths at the end of the observation period. | From starting NAT until end of the observation period (December 2019) | |
| The number (percentage) of patients presenting disease progression at the end of the observation period. | Disease progression will be considered as the development of metastatic disease and/or an increase in the primary tumor size. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
All BR-PDAC patients that required an evaluation by the Digestive and General Surgery Department from January 2010 to December 2019 were assessed for eligibility. These patients live within the Bellvitge University Hospital (tertiary level hospital) service area.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juli Busquets, MD, PhD | Contact | 034932607623 | jbusquets@bellvitgehospital.cat | |
| Luis Secanella, MD | Contact | 034932607623 | lsecanella@bellvitgehospital.cat |
| Name | Affiliation | Role |
|---|---|---|
| Luis Secanella, MD | Hospital Universitari de Bellvitge | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D021441 | Carcinoma, Pancreatic Ductal |
| ID | Term |
|---|---|
| D044584 | Carcinoma, Ductal |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
Not provided
Not provided
Not provided
Not provided
Not provided
| No Resection | Procedure | Type A BR-PDAC patients who did not have a favorable tumor/vascular structures relationship confirmed during surgical exploration did not undergo resection. |
|
| From starting NAT until end of the observation period (December 2019) or death (whichever occurs first). |
| Progression-Free Survival | Time until disease progression | From starting NAT until end of the observation period (December 2019) or disease progression (whichever occurs first). |
| The evolution of the plasmatic levels of CA 19-9 | From starting NAT until end of the observation period (December 2019) or disease progression (whichever occurs first). |
| The evolution of the degree of vascular involvement in 64-MDCT scans | The tumor's anatomical relationship with neighboring vascular structures; measured with 64-MDCT scans. | From starting NAT until end of the observation period (December 2019) or disease progression (whichever occurs first). |
| From starting NAT until end of the observation period (December 2019) |
| The number (percentage) of patients presenting stable disease at the end of the observation period. | Stable disease will be considered as an insufficient increase or reduction in the primary tumor size or in its relationship with neighboring vascular structures (i.e., cases that cannot be classified as responders). | From starting NAT until end of the observation period (December 2019) |
| The number (percentage) of patients considered responders at the end of the observation period. | Patients will be considered responders when the primary tumor presents a reduction in size and/or in its relationship with neighboring vascular structures. | From starting NAT until end of the observation period (December 2019) |
| The number (percentage) of patients surgically explored at the end of the observation period. | From starting NAT until end of the observation period (December 2019) |
| The Resection Rate at the end of the observation period. | The Resection Rate will be calculated by dividing the total number of resections performed by the total number of patients treated with NAT. | From starting NAT until end of the observation period (December 2019) |
| D009370 |
| Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D010190 | Pancreatic Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |