A prospective single-centre pilot study investigating the feasibility and safety of EUS-guided choledochostomy as primary drainage strategy in patients with distal malignant biliary obstruction using a FCSEMS through LAMS to reduce stent dysfunction.
The investigators' goal is to conduct a prospective multicenter study to evaluate the yield and outcomes of screening of pancreas cancer in individuals who are at-risk for pancreatic cancer. We plan to use International Cancer of the Pancreas Screening (CAPS3) Consortium recommendations to standardize study population, screening methodology, and study outcomes.
The purpose of this study is to determine the feasibility and safety of combining digoxin as a modulator of the hypoxia pathway in combination with FOLinic acid, 5-Fluorouracil, IRINotecan and OXaliplatin (FOLFIRINOX) in participants with resectable pancreatic cancer.
A dose escalation, safety study of local (intra-arterially) delivered gemcitabine to the pancreas using the RenovoCath R120 catheter to determine the maximum tolerated dose.
The investigators hypothesize that intensification of local therapy will lead to improvements in local control and survival in patients with unresectable and borderline resectable pancreatic cancer. We propose to do this by combining nab-paclitaxel concurrently with dose-escalated radiation therapy. In the first part of this phase I study (sub-trial 1), the nab-paclitaxel dose will be escalated while the radiation dose is held constant at a standardly accepted level. The use of this novel chemoradiotherapy regimen will take advantage of nab-paclitaxel's specific anti-tumor and anti-stromal properties, which may enhance the efficacy of radiation therapy, and thereby improve local control. After the MTD of nab-paclitaxel had been determined, a second arm in sub-trial 1 will evaluate the addition of paricalcitol to nab-paclitaxel concurrently with dose-escalated radiation therapy. In addition, after the MTD of the nab-paclitaxel is reached in sub-trial 1 arm A, in the second part of this study (sub-trial 2), we will administer nab-paclitaxel at the determined MTD concurrently with escalated doses of radiation. We will utilize IMRT or protons to safely deliver high doses of radiation while maximally sparing surrounding normal tissue. Patients will also preferentially have 2-3 fiducial markers placed in or around the tumor for daily localization. Chemotherapy before and/or after chemoradiotherapy may be given as per standard of care. Correlative tissue and serum biomarkers are an important, but optional, part of this study.
The primary objective of the study will be to estimate the prevalence of germline mutations in patients who present consecutively within 12 weeks of a confirmed diagnosis of pancreatic ductal adenocarcinoma.
The purpose of this study is to find out the maximum dose of SBRT that can be safely given after chemotherapy for treatment of pancreatic cancer that cannot be removed surgically.
Diagnosis of lesions of pancreas, the upper gastrointestinal tract, as well as adjacent structures, such as lymph nodes, is still showing advancements especially with the increased use of endoscopic ultrasound. Endoscopic ultrasound-guided fine needle aspiration and fine needle biopsy (EUS-FNA/FNB) have become mainstay diagnostic techniques for these lesions. The purpose of the study is to compare between the currently used, ProCore needles and the new biopsy needle, SharkCore, for the histological diagnosis and evaluation of lesions.
Few chemotherapeutic options exist for pancreatic cancer. Moreover, objective criteria are lacking for deciding which regimen is more beneficial for patient presenting with metastases at diagnosis.
This study investigates whether organoid generation from tumour samples of pancreatic cancer is a safe and feasible process for testing of multiple chemotherapy regimens in the laboratory.
By participating to this study, patients will have a part of the tumour tissue retrieved and sent to the laboratory for organoid generation and drug testing. For surgically-resectable tumors, tumoral tissue samples will be collected from the main surgical specimens, before sending it for final pathological examination. In case of suspected metastatic lesion at diagnosis, curative surgery is not indicated. Therefore, we will offer patients to undergo port-a-cath implantation for chemotherapy delivery and concomitant laparoscopic surgical excisional biopsy of suspicious metastatic (either hepatic or peritoneal) lesions.
At this stage of the study, the treatment that the patient will receive after surgery will not be affected by the results of the laboratory testing. In fact, all patients will receive the standard of care treatment based on the most recent oncologic guidelines and on the oncologist's clinical judgement. As part of the study, each patient will be followed for 30 days to assess possible surgical complications related to the surgical biopsy.
This study will help to speed up the implementation of organoid generation in the clinical routine for the choice of the best treatment of patients affected by pancreatic cancer.
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Infusing doxorubicin beads into the liver, and blocking blood flow to the tumor, may keep doxorubicin near the tumor and kill more tumor cells.
PURPOSE: This clinical trial is studying the side effects of doxorubicin beads and to see how well they work in treating patients with unresectable liver metastases from neuroendocrine tumors.
