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NCT05351983
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.
NCT06344507
The aim of the TAILOR-EUS study (Iconographic Registry of Bilio-Pancreatic Endoscopic Ultrasound Procedures) is to establish a clinical registry comprising images and videos generated during endoscopic procedures conducted for the investigation of pancreatic diseases (PD). The study will compile historical, pathological, and imaging data from approximately 12,000 patients (2,000 retrospectively and 10,000 prospectively) who underwent endoscopic ultrasound procedures for inflammatory pancreatic conditions (e.g., acute, recurrent, chronic pancreatitis), autoimmune bilio-pancreatic diseases (e.g., autoimmune pancreatitis), neoplastic bilio-pancreatic conditions, and screenings for individuals at high risk of developing such diseases at the Bilio-Pancreatic Endoscopy and Endoscopic Ultrasound Unit of the IRCCS San Raffaele Hospital between 2000 and 2027. Participants have undergone or will undergo the standard diagnostic pathway appropriate for their conditions as part of routine clinical practice. All instrumental examinations and endoscopic ultrasound procedures are integral to the standard diagnostic and therapeutic approach for pancreatic diseases.
NCT06563232
The investigators conduct a multicenter randomized controlled study to evaluate the diagnostic value and safety of 22G Adapt Aspiration puncture needle for histopathology of solid lesions.
NCT04104230
The Quebec Pancreas Cancer Study is a prospective clinic-based study consisting of clinical, family history and epidemiologic data, with accompanying biospecimens, from patients diagnosed with either pancreas cancer, a related cancer or a related pre-cancerous condition, and their families.
NCT05714111
The purpose of this study is to collect all radiological data which evaluated with clinical data may help assess malignancy and prognosis of pancreatic disease.This registry aims to collect retrospective data from 2014 and prospective data until 2027 with a maximum follow-up of 3 years per patient.
NCT03834701
This study evaluates the possibility and the safety of performing local therapy for Pancreatic neuroendocrine neoplasms (PanNENs) using radiofrequency ablation of the tumor under ultrasonography (EUS) guidance.
NCT02243358
To evaluate the safety and effectiveness of a novel neoadjuvant treatment strategy incorporating 5-fluorouracil/leucovorin with oxaliplatin ( FOLFOX )chemotherapy in combination with chemo-radiation with gemcitabine.
NCT04164602
The aim of this study is to accomplish the early diagnosis of pancreatic cancer, in patients over 60 years of age with newly diagnosed diabetes. Only patients with type 2 diabetes are meant to be included. The early diagnosis of pancreatic cancer could be the way to enable efficient cure for the patients.
NCT04841616
Endoscopic ultrasound (EUS) is an indispensable tool for tissue acquisition for pancreatic lesions. Fine needle aspiration (FNA) is once considered as the first line diagnostic method especially when rapid on-site evaluation (ROSE) by cytopathologist is available. However, FNA alone has several limitations including inadequate acquisition of cells, and unable to provide core tissue for further histological analysis. Furthermore, ROSE is not available in many endoscopic centres due to limited resources. Endosonographers around the world, are discovering methods to overcome the limitations, including the use of new on-site evaluation technique by endoscopists, new fine-needle biopsy (FNB) needles, contrast-enhanced harmonic EUS-guided FNB. In this study, the investigators propose to compare the diagnostic performance between contrast-enhanced EUS-guided FNB versus conventional EUS-guided FNB technique with an aim to define the best EUS-guided tissue acquisition technique in the absence of ROSE. Results obtained from this research is expected to have significant impact in providing new insights on the best EUS-guided tissue acquisition method. It may replace FNA with ROSE as the gold standard for EUS-guided tissue acquisition in an affordable manner. It will also save the patients from unnecessary procedures and fasten the treatment pathways.
NCT05356039
This study aims to assess overall survival, quality of life and resection rates in locally advanced pancreatic cancer
NCT03957135
When pancreatic cancer of the body and tail is diagnosed, a distal pancreatectomy is planned. This operation can be performed with open surgery, or with laparoscopic surgery. This study is a multicenter randomized controlled trial to evaluate the operative outcomes and survival of open versus laparoscopic distal pancreatectomy for pancreatic cancer of the body and tail.
NCT05095831
The diagnosis of pancreas diseases is based on a combination of clinical signs, symptoms, and laboratory tests, but mainly on imaging techniques such as computed tomography (CT) and magnetic resonance (MR). However, CT/MR have variable sensitivity and specificity, with certain disadvantages. Endoscopic ultrasound with elastography is an important resource with higher diagnostic accuracy in assessing solid pancreas lesions. Shear wave velocities of healthy parenchyma, acute, chronic and autoimmune pancreatitis, neoplastic lesions of the pancreas must be evaluated and compared.
NCT03649035
Pancreatic cancer represents the 11th most commonly diagnosed cancer in men and 9th in women, being the third leading cause of cancer-related death in the Western countries. Pancreatic cancer has a very poor prognosis and median overall survival is less than 5 months in population-based studies. Approximately 80% of patients with pancreatic cancer present with unresectable disease, which is either due to locally advanced or metastatic disease. About 40% of patients have metastases at the time of diagnosis and in another 30 to 40 % of the patients tumour resection is not feasible because of vascular invasion, or poor general conditions. In resectable patients surgical resection with negative margins (R0) continues to be worldwide considered the only chance to cure, however, this standard treatment is usually reserved to a small number of patients. In patients with locally advanced tumour, neoadjuvant treatment has been proposed in various modalities as a way to decrease size and downstage the tumour leading to a resectable disease. Several phase I - II studies have shown the capability of chemotherapy alone or chemo radiotherapy based regimens to increase the resection rates of these patients and the related median overall survival. Systemic chemotherapy followed by chemoRT or stereotattic body radiation therapy (SBRT) is an option for selected patients with unresectable disease and good PS who have not developed metastatic disease. This sequence is especially recommended in cases in which it is highly unlikely that the patient will become resectable (ie, complete encasement of SMA/superior celiac artery). Due to the significant rate of toxicity of the radio therapy (RT) treatment alone or in adjunct to chemotherapy, other local treatments with the goal to downstage the primary tumour with less or no toxicity as compared to RT have been proposed. Radiofrequency (RF) has been used with success in solid cancers like the hepatocellular carcinoma while cryoablation has been used for breast and renal cancers. RFA has been applied in few clinical trials in human pancreatic cancer either without any imaging guidance or just under intra-operatory ultrasound control during palliative open surgery. The HybridTherm probe (HTP), (ERBE Elektromedizin GmbH, Tübingen, Germany) combines bipolar RF-ablation with cryogenic induced cooling. A bipolar radiofrequency system creates ablation with less collateral thermal damage than standard monopolar systems but with the trade-off to lose overall efficiency. In a recent in-vivo study the feasibility of the HTP in patients with unresectable locally advanced pancreatic adenocarcinoma has been shown. HTP has been applied under EUS-guidance to patients who have been already treated by chemotherapy (two lines) and in many cases with the adjunct of RT.
NCT04687410
The aim of this study is to compare tissue quality and molecular yield between a novel crown-cut biopsy needle (FNB) and a standard aspiration needle (FNA) for EUS-guided diagnosis of solid pancreatic lesions.
NCT03803930
The purpose of this study is to compare the diagnosis accuracy of 22G EUS Procore fine needle biopsy （FNB）device and 20G EUS Procore fine needle biopsy device for solid pancreatic lesions.
NCT00198081
The purpose of the study is to find out whether the drug celecoxib has beneficial effects on people with pre-cancerous lesions of the pancreas.
NCT00930410
The endomicroscopy is an adaptation of traditional optical microscopy in the digestive endoscopy. Furthermore, with the integration of a miniaturized laser confocal microscope to a videoendoscope, it's possible to study the digestive mucous by "optical biopsy". This monocentric, non randomized and prospective study uses the Intra-ductal confocal endomicroscopy for the characterization of pancreas and bile duct tumor.
NCT00683358
Feasibility and efficacy of combined modality intervention using chemotherapeutic agent gemcitabine with anti-angiogenic peptide vaccination targeting VRGFR1 should be determined in case of advanced/inoperable or therapy-resistant pancreatic cancer patients. Gemcitabine 1,000mg/m2 BSA will be administered on day1, day8, day15, day29, day36, day43, respectively. HLA-A\*2402-restricted VEGFR1-derived peptide (VEGFR1-A24-1084; SYGVLLWEI) emulsified with Montanide ISA51 will be subcutaneously injected twice weekly for 8weeks (total 16 doses).