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Trial Title:
Predictive Factors for Resection and Survival in Type A Borderline Resectable Pancreatic Ductal Adenocarcinoma Patients After Neoadjuvant Therapy
NCT ID:
NCT05489458
Condition:
Carcinoma, Pancreatic Ductal
Conditions: Official terms:
Adenocarcinoma
Carcinoma, Pancreatic Ductal
Conditions: Keywords:
BR-PDAC
Pancreatic Ductal Adenocarcinoma
Borderline Resectable
CA 19-9
Anatomical
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Procedure
Intervention name:
Resection
Description:
Type A BR-PDAC patients who had a favorable tumor/vascular structures relationship
confirmed during surgical exploration underwent resection.
Arm group label:
Exploratory Surgery with Resection
Intervention type:
Procedure
Intervention name:
No Resection
Description:
Type A BR-PDAC patients who did not have a favorable tumor/vascular structures
relationship confirmed during surgical exploration did not undergo resection.
Arm group label:
Exploratory Surgery without Resection
Summary:
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.
Detailed description:
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Patients ≥18 years old.
- Both sexes.
- Diagnosed with a type A BR-PDAC between January 2010 and December 2019.
- Minimum follow-up period of 12 months.
Exclusion Criteria:
- Patients diagnosed with a type B or type C BR-PDAC.
- Patients diagnosed with a type A BR-PDAC who had disease progression prior to
receiving NAT.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
September 2022
Completion date:
January 2023
Lead sponsor:
Agency:
BUSQUETS, JULI
Agency class:
Other
Source:
Hospital Universitari de Bellvitge
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05489458
