View clinical trials related to Bile Duct Neoplasms.
Filter by:The goal of this randomized controlled trial is to compare uncovered, partially covered, and fully covered self-expandable metal stents (SEMS) in the palliative treatment of distal malignant biliary obstruction in a Swedish multicenter study. The main questions it aims to answer is: Is the stent patency rate different depending of stent type? Is the stent patency time different depending of stent type? Is the patient survival different between the groups? Which complications are seen, and do they differ between the groups? Are there different mechanisms behind the stent failure depending on stent type? Patients will at ERCP, with a guidewire passed through the stenosis in the bile duct, be allocated to either uncovered, partially covered, and fully covered (SEMS). Totally, 450 patients will be recruited, 150 in each study arm, according to the power analysis. Patients will be followed in a monthly surveillance by a study nurse up to 12 months after stent insertion. Endpoints are: alive after 12 months with a patent stent, death with a patent stent, stent dysfunction with a subsequent intervention i.e. repeated ERCP or PTC = "objective stent failure", stent dysfunction, jaundice or cholangitis, but not intervention has been undertaken due to a poor condition of the patient, "clinical stent failure", the patient has undergone curative surgery or a bilio-enteric by-pass (a gastro-enteroanastomosis or a duodenal stent is not a reason for exclusion), the patient refuses further follow-up.
This is a randomized trial to compare the standard echoendoscope with the newly developed EndoSound Visual System in the evaluation of lesions in the gastrointestinal tract.
Biliary stricture is mainly malignant in the adults and caused by several types of fatal malignancies such as pancreatic cancer, cholangiocarcinoma, and metastatic tumor, which have poor prognosis that the overall survival of unresectable lesions is no more than 15 months. The poor outcome often relates to a lack of reliable strategies for early diagnosis, which results in most patients with malignant biliary stricture being already advanced-stage disease at presentation. Therefore, it is critical to discover novel and effective strategies for the early diagnosis of malignant biliary strictures. Brush cytology and biopsy during endoscopic retrograde cholangiopancreatography (ERCP) are the main methods for recognizing malignant diseases of the bile duct, but their sensitivity is relatively low, 45% and 48.1%, respectively. Even when combined with other biomarkers like carbohydrate antigen 19-9 (CA19-9), their sensitivity is still less than 80%. In the previous study, the investigators found that bcf-eccDNA has excellent diagnostic value in predicting uncertain bile duct stricture, and the sensitivity and specificity of a related eccDNA in 40 samples are 80.8% and 100%. The sensitivity and specificity of another eccDNA were 92.3% and 92.9%, respectively. However, the sample size is still relatively small, and further prospective studies are needed to evaluate its diagnostic efficacy.
The goal of this clinical trial is to provide evidence for the general tolerability of radiofrequency ablation (bRFA) in patients with unresectable bile duct cancer undergoing systemic palliative treatment consisting of chemotherapy (gemcitabine and cisplatin) plus durvalumab (immune-checkpoint-inhibitor, ICI). The main question it aims to answer is whether it is safe to combine chemotherapy (gemcitabine and cisplatin) and immunotherapy (durvalumab) - CICI therapy. Participants will be assigned to either the control group or the experimental group. In the control group, the standard of care consists of endoscopy with stent placement in the bile duct and CICI, whereas in the experimental group, bRFA will be performed in addition to the standard of care. Participants will be followed up for 6 months, during the follow-up, the stage of the tumor, blood examination, the duration of the stent from the insertion until its failure, adverse events and quality of life will be examined. Researchers will compare the standard of care alone to the experimental group to see if the additional bRFA procedure causes higher or no difference in adverse events rate.
This is a first-in-human, single-arm, open-label, dose escalation clinical study to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics, immunogenicity and preliminary efficacy of UCMYM802 (Circular mRNA encoding Anti-Mesothelin CAR-T) injection in patients with Mesothelin-positive advanced malignant solid tumors.
This is a multi-center, prospective, feasibility study using a 1.1 mm flexible cryoprobe SU via percutaneous access in the bile duct. The device has a CE-approval. First feasibility and safety for application assessed in the bile duct performed ex vivo and in a patient case report study. The study will take place at 5 different sites in Germany. Recruitment is competitive. In total, 15 patients will be enrolled. Patients are screened for study inclusion at the participating hospitals. Primary objective: • Feasibility of percutaneous cryobiopsy in the bile duct Secondary objectives: - Size of biopsy (mean area (in mm2) of each biopsy technique) - Percentage of successful retrievals of biopsies by each biopsy technique - Representativeness of each biopsy sample - Quality of each biopsy sample - Grade of crash artifacts occurrence defined as crush artifact area per biopsy - Rate of safety-relevant aspects, like for example bleeding, post-bleeding, perforation, infection and abscess
This is a early Phase 1 open-label study to explore the safety and possible efficacy of EX02 CAR T cell therapy in the treatment of patients with unresectable and/or metastatic pancreatic/bile duct cancer. Each participant will undergo leukapheresis after enrolment, receive treatment of the conditioning chemotherapy of cyclophosphamide and fludarabine, and an intra-tumoral injection or intraperitoneal infusion of Ex02 CAR T cells, probably followed by an intravenous infusion of EX02 CAR T cells. Each participant will proceed through the following study procedures: - Screening - Enrollment/Leukapheresis - Conditioning chemotherapy - CAR T treatment - Post-treatment assessment - Long-term follow-up
The goal of this clinical trial is to learn about radiofrequency ablation in patients with unresectable bile duct cancer who receive systemic chemotherapy and bile duct stenting. The main questions it aims to answer are: - Does radiofrequency ablation of tumorous bile duct occlusion reduce risk of complications in these patients (eg stent dysfunction, delay of chemotherapy, infections etc)? - Is radiofrequency ablation safe in these patients? All participants will receive standard treatment with systemic chemotherapy and bile duct stenting. Researchers will compare two groups (one group will receive additional radiofrequency ablation, the other not).
The goal of this observational study is to detect the methylation characteristics of cfDNA in the bile and plasma of patients with bile duct stricture. The main question it aims to answer is: Can the developed model, using peripheral blood and bile cell-free DNA sequencing, work well in screening and classifying unknown biliary stricture? Participants will collect approximately 10ml of peripheral blood and 5ml of bile from the patient.
The incidence rate and mortality rate of periampullary cancer at home and abroad both show an increasing trend, seriously affecting the health level of the people. Pancrecoduodenectomy (PD) is the only effective treatment for periampullary cancer. However, due to the complex technology and difficulty of PD surgery, laparoscopic pancreaticoduodenectomy (LPD) is more difficult, and the postoperative mortality can reach 5%. The important reason is the most serious complication- -pancreatic fistula. The occurrence of pancreatic fistula is related to many factors, and the most critical factor is the method and technology of pancreatico-intestinal anastomosis, so the improvement and innovation of pancreaticoco-intestinal anastomosis technology has always been a hot topic in surgical clinical research. Blumgart Pancreatic anastomosis was originally created by Professor L.H.Blumgart in the United States, and was widely used in OPD due to its low incidence of pancreatic fistula. However, the traditional Blumgart anastomosis is complicated and is not suitable for application in LPD. According to our own experience, our team simplified and improved the traditional Blumgart anastomosis to OPD, and through retrospective study, it has the advantages of reducing the incidence of pancreatic fistula. However, the application value in LPD still needs to be further discussed. Therefore, this study intends to use a prospective randomized controlled trial, using the LPD patients with traditional Blumgart pancreatecointestinal anastomosis as the control group, and the LPD patients with modified Blumgart pancreatecointestinal anastomosis as the test group, compare the clinical relevant indicators and the incidence of postoperative complications, and explore whether the application value in LPD can truly simplify the surgical procedure and ensure the lower incidence of pancreatic leakage.