araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

Clinical trial: Comparison of Biliary Stenting Alone vs. Stenting With Photodynamic Therapy (PDT) During ERCP

Summary: This study entails retrospective and prospective review of data from a database protocol. Data gathered will be then analyzed for a set amount of patients. In this study, the investigators will compare biliary stenting vs. biliary stenting plus photodynamic therapy (PDT) and assess if PDT can improve quality of life and prolong survival.

Detailed description: Successful palliation of biliary obstruction is the main goal for reducing morbidity and mortality in patients with biliary disease and biliary obstruction related to cholangiocarcinoma. Surgical biliary bypass is unfortunately complicated by a 30-day postoperative mortality rate of between 7 and 24%. Moreover, because of recovery time the quality of life following surgery is only improved in a minority. At present endoscopic insertion of a plastic or metal stent is the method of choice to relieve obstructive jaundice without the high morbidity and mortality associated with surgery. But this relief is unfortunately temporary since stents tend to become obstructed and the fact that effective biliary drainage in the proximal lesion is challenging. Photodynamic Therapy (PDT) is a new therapeutic approach that specifically targets neoplastic cells. This therapy involves the intravenous administration of a photosensitizing agent followed by activation of the agent by illumination with non-thermal light of a specific wavelength, resulting in cell death from direct cytotoxicity and ischemic necrosis. Cytotoxicity is directly proportional to tissue oxygenation.
  A prospective, randomized and controlled trial study by Ortner et all confirmed the significant advantage of PDT with regard to relief of jaundice, quality of life, and survival. The improvement of survival in the randomized PDT group was so impressive that it was believed unethical to continue with randomization after the first 39 patients (20 and 19 in each group).Previously, the principal investigator conducted such a study (and also conducted Endoscopic Retrograde Cholangiopancreatography with PDT) at the University of Virginia, and would continue to conduct these procedures, as well as the study at WCMC.

Eligibility: Inclusion Criteria:
  -  Any patient who has undergone ERCP (Endoscopic Retrograde Cholangiopancreatography) and Biliary stenting with or without Photodynamic Therapy.
  -  Biliary disorder or obstruction due to Cholangiocarcinoma.
  -  Above 18 years of age.
  Exclusion Criteria:
  -  Any patient who has not undergone ERCP and biliary stenting.
  -  Not diagnosed with Cholangiocarcinoma.
  -  Below 18 years of age

Relevance to patient case: not relevant
Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

Clinical trial: Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry

Summary: The objective of this protocol is to establish a multicenter registry to evaluate the impact of radiofrequency ablation in the management of patients with pancreatico-biliary disorders including malignancies.

Detailed description: Bile duct cancer and pancreatic cancer are cancers that cannot be surgically removed. As the cancer grows, it blocks the drainage of the bile ducts that carry digestive juices from the gall bladder and pancreas to the small intestine. ERCP (endoscopic retrograde cholangiopancreatography) is often prescribed during which a tube with a tiny camera attached is inserted through the subject's mouth and advanced to a place in the small intestine where the bile duct empties. Through this scope the doctor enlarges the ducts with tiny balloons and places plastic or metal stents (straws) that help keep the bile ducts open so they can drain properly. However, due to the cancer, the stents are blocked eventually.
  The purpose of this registry is to record information and evaluate the impact of radiofrequency ablation (RFA) of endoscopic radiofrequency ablation (RFA) probes in improving the management of bile duct cancer or pancreatic cancer by ablating the tissue in the bile duct(s) before the stent(s) are implanted. By using radiofrequency (RF) energy to heat the tissue in the duct(s) prior to stent(s) insertion, the surrounding tissue becomes coagulated and this may delay tumor growth and the time before the stent lumen becomes blocked. Thereby, allowing increased periods between the need for intervention and further stent implantation(s). The registry will evaluate the efficacy and safety of RFA procedures conducted for pancreatico-biliary disorders.
  The safety and efficacy of various radio frequency ablation probes have been assessed in a series of studies. This multi-center registry has been initiated:
  1. To document the immediate and post procedure clinical performance of radio frequency ablation in a 'real world' patient population requiring stent implantation for pancreaticobiliary disorders.
  2. To assess the immediate and 6 months post procedure adverse event rate in patients.
  3. To assess the impact of RFA on the life expectancy of patients suffering from pancreaticobiliary malignancies.

Eligibility: Inclusion Criteria:
  -  Patients who have undergone RFA for pancreaticobiliary disorders
  -  Above 18 years of age
  Exclusion Criteria:
  -  Patients who have not undergone RFA
  -  Below 18 years of age

Relevance to patient case: not relevant
Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

Clinical trial: Pilot Study of Irreversible Electroporation (IRE) to Treat Metastatic Liver Cancer & Cholangiocarcinoma

Summary: Single-arm pilot clinical trial. Patients will be subjected to irreversible electroporation (IRE) as the sole treatment of nodules not considered treatable by resection or thermal ablation.

Detailed description: Single-arm pilot clinical trial. Patients will be subjected to irreversible electroporation (IRE) as the sole treatment of nodules not considered treatable by resection or thermal ablation.
  This pilot study was designed to study the feasibility and safety of treatment as an alternative therapeutic IRE in the treatment of neoplastic nodules in the liver, with particular reference to metastatic liver cancer and cholangiocarcinoma, where the current therapeutic arsenal is inadequate or counter-indicated.
  To perform the IRE procedure the IRE NanoKnife™ System (AngioDynamics) will be used.

Eligibility: Inclusion Criteria:
  -  older than 18 years,
  -  male or female,
  -  diagnosis of secondary liver cancer or cholangiocarcinoma based on positive biopsy or noninvasive criteria,
  -  presence of at least one lesion untreatable by surgical resection or ablation for microwave or radio frequency,
  -  the target nodule must have a diameter of ≤ 5 cm
  -  ECOG score(Eastern Cooperative Oncology Group) 0,
  -  ASA score (American Society of Anesthesiologists) ≤ 3,
  -  prothrombin time ratio >50%
  -  platelet count >50x10^9/l,
  -  patient's ability to discontinue anticoagulant and antiplatelet therapy for seven days before and seven days after surgery with NanoKnife™,
  -  ability to understand and willingness to sign the written informed consent form (ICF),
  -  life expectancy of at least 3 months.
  Exclusion Criteria:
  -  presence of more than 5 liver lesions,
  -  previous treatment of the target nodule,
  -  patient received systemic chemotherapy within 30 days of treatment with the IRE NanoKnife™,
  -  heart failure, coronary artery disease or arrhythmia in progress, active implantable devices (eg pacemaker),
  -  pregnant women or women of childbearing potential not using an acceptable method of contraception,
  -  patient undergoing treatment with an investigational drug within 30 days of treatment with the IRE NanoKnife™,
  -  in the opinion of the researcher, anyone who can not follow the calendar of visits and assessments of the Protocol.

Relevance to patient case: not relevant
Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

Clinical trial: Long Time Follow up After HJ Following Iatrogenic Bile Duct Injuries

Summary: Introduction: Bile duct injury (BDI) after cholecystectomy remains a serious complication with major implications for patient outcome. For most major BDIs, the recommended method of repair is a hepaticojejunostomy (HJ). We conducted a retrospective review from 5 Danish hepatobiliary centres aiming to examine the perioperative and the long-term outcome after reconstructive HJ.


Eligibility: Inclusion Criteria:
  -  All patients with iatrogenic Bile duct injury (BDI) after cholecystectomy reconstructed with hepatojejunostomy/choledochojejunostomy.
  Exclusion Criteria:
  -  Patients with non-cholecystectomy-related BDI or with cholecystectomy-related BDI that had been definitively managed by other techniques.

Relevance to patient case: not relevant
Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

Clinical trial: Stenting Malignant Jaundice for Quality of Life

Summary: Endoscopic stent insertion is considered the method of choice for palliation of malignant bile duct obstruction (MBDO). However, it can cause complications and requires periodic stent exchanges. While endoscopic stenting is clearly indicated for relief of cholangitis or refractory pruritus, its role in patients with jaundice alone is less clear. Endoscopic stenting for this relative indication might be justified, if there is a significant improvement in quality of life (QOL) of such patients. The aim of the investigators study was to determine whether endoscopic stenting for MBDO results in improved QOL.

Detailed description: Most malignant tumors causing bile duct obstruction, such as pancreatic adenocarcinoma, gallbladder carcinoma or cholangiocarcinoma, have an extremely poor prognosis. At the time of diagnosis the majority of these tumors will be unresectable with a median survival of 4-6 months. Palliation is the goal for those patients with unresectable tumors and limited survival and for those at high risk for attempts at curative resection.
  Endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic stent insertion is considered the method of choice for palliative treatment of malignant bile duct obstruction (MBDO). However, it can cause complications, such as pancreatitis, bleeding, perforation, cholangitis and stent migration in a significant proportion of treated patients. Clogging of plastic stents is a predictable consequence and requires periodic stent exchanges with attendant risks and costs. While endoscopic stenting is clearly indicated for relief of cholangitis or refractory pruritus, the role of stenting in patients with jaundice alone, abdominal pain, or failure to thrive due to malignancy is less clear. Given the risk for complications and costs, endoscopic therapy might be justified in these clinical scenarios if quality of life (QOL) is significantly improved. A few available studies have demonstrated improved QOL in stented patients. However, these studies include a small number of patients and/or are retrospective in design. Therefore, more evidence to support routine palliative biliary drainage in patients with MBDO is desired.

Eligibility: Inclusion Criteria:
  -  Patients with suspected or proven malignant biliary obstruction who were unresectable or inoperable and were undergoing ERCP and biliary stenting for biliary depression.
  Exclusion Criteria:
  -  Had previously undergone biliary stenting
  -  Surgery was planned
  -  A guidewire could not be passed through the stricture
  -  Suspected survival of < 3 months
  -  Impending duodenal obstruction

Relevance to patient case: not relevant
Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

Clinical trial: Hepatic Arterial Infusion in Treating Patients With Locally Advanced, Non-Metastatic Cholangiocarcinoma

Summary: This pilot clinical trial studies the safety and effectiveness of continuous hepatic arterial infusion (HAI) of floxuridine (FUDR) alone or in combination with other chemotherapeutic drugs in treating patients with locally advanced cholangiocarcinoma that cannot be removed by surgery. HAI is a method to deliver higher concentrations of FUDR more directly to liver tumors and reduces side effects. HAI alone or in combination with oxaliplatin and/or gemcitabine may significantly improve clinical outcomes of patients with locally advanced cholangiocarcinoma.


Eligibility: Inclusion Criteria:
  -  Patient must have suspected intrahepatic or hilar cholangiocarcinoma with minimal extrahepatic disease. Diagnosis must be histologically or cytologically confirmed for continued treatment on study after pump placement.
  -  Patient must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan/MRI
  -  Patient must have disease that is unresectable or borderline resectable with < 70% liver involvement by cancer
  -  Patient must be >= 18 years old.
  -  Patient's Eastern Cooperative Oncology Group (ECOG) performance status must be =< 2 (Karnofsky >= 60%)
  -  Patient must have normal organ and marrow function as defined below:
  -  Absolute neutrophil count >= 1,500/mcL
  -  Platelets >= 75,000/mcL
  -  Total bilirubin =< 2 mg/dL
  -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 5 X institutional upper limit of normal
  -  Creatinine <= institutional upper limit normal
  -  Patient must be able to understand and willing to sign a written informed consent document
  Exclusion Criteria:
  -  Patients must not have had prior treatment with FUDR
  -  Patient must not be receiving any other investigational agents
  -  Patient must not have a diagnosis of Gilbert's disease
  -  Patient must not have a diagnosis of hepatic encephalopathy
  -  Patient must not have had prior external beam radiation to the liver
  -  Patient must not have a diagnosis of sclerosing cholangitis
  -  Patient must not have any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  -  Patient must not be pregnant or breastfeeding

Relevance to patient case: not relevant
Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

Clinical trial: Endoscopic Therapy of Malignant Bile Duct Strictures

Summary: Patients with malignant bile duct stenosis have poor prognosis and most of the patients are not good candidate for surgery at the time of diagnosis. Placement of the stent is the palliative care for these patients. However over 50% of the stents get blocked within 6-8 months. Use of the radiofrequency ablation before the stent placement may improve stent patency. Heat will be applied to the bile duct in order to open the blockage and prevent the re-growth of tissue into the stent. The investigators are looking to see how safe and feasible RFA catheter is in patient with malignant bile duct stenosis.

Detailed description: As part of medical care subjects will be undergoing an endoscopic procedure (ERCP) in order to evaluate and stent a bile duct blockage. During the ECRP and just prior to the stent placement subjects will undergo the placement of a radiofrequency ablation catheter into the bile duct blockage. Heat will be applied to the bile duct in order to open the blockage and prevent the re-growth of tissue into the stent; after the radiofrequency ablation, stent will be placed. Three days after the procedure subjects will receive a phone call from the research coordinator to check any adverse or unwanted effects of the treatment. The study procedure (radiofrequency ablation) takes place over 10 minutes during ERCP. The subjects will undergo routine follow up for their medical problems. No follow up visits are required as part of the study.

Eligibility: Inclusion Criteria:
  -  Documented malignant biliary obstruction requiring ERCP guided stenting
  Exclusion Criteria:
  -  Coagulopathy (INR > 2.0 or PTT > 100 sec or platelet count < 50,000)
  -  Evidence of high-grade symptomatic duodenal obstruction
  -  Poor performance status
  -  Active suppurative cholangitis
  -  Complex stenoses will not be eligible for the trial
  -  Patients without access to duodenum or ampulla are not candidates for ERCP and stenting
  -  Candidates for a Whipple resection
  -  Patients who do not speak English

Relevance to patient case: not relevant
Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

Clinical trial: Safety and Efficacy of Activated Recombinant Human Factor VII in Patients Undergoing Orthotopic Liver Transplantation

Summary: This trial is conducted in Europe, North America and Oceania. The aim of this trial is to evaluate the haemostatic efficacy of activated recombinant human factor VII in subjects undergoing orthotopic liver transplantation surgery.


Eligibility: Inclusion Criteria:
  -  Scheduled to undergo orthotopic liver transplantation
  -  Liver disease classified as Child-Turcotte (Pughs modification) score B or C
  Exclusion Criteria:
  -  Previous liver transplantation
  -  Scheduled multi-organ transplantation
  -  Scheduled for living related donor transplantation
  -  Present renal insufficiency requiring dialysis
  -  Pregnancy

Relevance to patient case: not relevant
Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

Clinical trial: Cardiac CT's Role in Asymptomatic Patients With Diabetes and Metabolic Syndrome

Summary: This study looked at the role of cardiac CT in improving risk factor control in those with diabetes.


Eligibility: Inclusion Criteria:
  -  Age > 18
  -  Diabetes
  -  Metabolic Syndrome
  Exclusion Criteria:
  -  Symptoms of heart disease
  -  Heart Disease
  -  Renal disease

Relevance to patient case: not relevant
Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

Clinical trial: Bile and Bile Duct/Pancreatic Duct Brushings Database for Patients With Pancreato-biliary Stricture

Summary: The purpose of this study is to create a long-term storage of bile and brushings of pancreato-biliary duct in patients diagnosed with pancreato-biliary stricture for future research.
  Recently, a lot of research has been done to test for certain markers in the bile and brushings to detect cancer in a stricture. The samples will be used to measure biomarkers (proteins) in biliary diseases.

Detailed description: Recently, a lot of research has been done to test for certain markers like fluorescence in situ hybridization (FISH), digital image analysis (DIA), and quantifiable morphometric results in biliary stricture brushings. Recently, polysomy FISH has been studied as a promising marker in predicting cancer in a pancreato-biliary stricture. Many genetic, epigenetic, and protein alterations arise during pancreaticobiliary tumor process. The types of markers that have been commonly evaluated as diagnostic assays are mutations, chromosomal gains and losses, and DNA methylation alterations. However there are only a few studies in this area. Testing for these markers can help determine whether the narrowing or stricture in your bile duct is cancer or not.

Eligibility: Inclusion Criteria:
  -  Any patient diagnosed with pancreato-biliary stricture.
  -  Age >18 years
  -  Ability to provide an informed consent
  Exclusion Criteria:
  -  Patients with altered mental status, who will not be able to provide an informed consent
  -  Pregnant women

Relevance to patient case: not relevant
Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

Clinical trial: Duodenal Cancer - Retrospective Analysis

Summary: To see how a cohorte of 55 patients over periode 1997-2011 were mannaged, treated and survived duodenal cancer. Also to see how advanced the tumors were at time of diagnose and at time of operation.


Eligibility: Inclusion Criteria:
  -  duodenal cancer
  Exclusion Criteria:
  -  other cancers of the upper GI tract such as pancreatic cancer,
  -  cholangiocarcinoma,
  -  papilla Vateri cancer

Relevance to patient case: not relevant
Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

Clinical trial: Protocol for High-Risk Assessment, Screening, and Early Detection of Pancreatic Cancer

Summary: The purpose of this study is to find out whether Endoscopic Ultrasound (EUS) can detect early stage pre-cancerous or cancerous changes in the pancreas in patients at high-risk for the development of pancreatic cancer. Endoscopic refers to the use of an instrument called an endoscope - a thin, flexible tube with a tiny video camera and light on the end. Ultrasound refers to an imaging technique that uses sound waves to produce pictures. EUS in this research study is a method of combining endoscopy and ultrasound imaging to obtain high quality images of the pancreas.


Eligibility: Inclusion Criteria:
  -  Patients will be eligible if they have 2 or more relatives with pancreatic cancer and have a first degree relationship with at least one of the relatives with pancreatic cancer
  -  If only 2 family members are affected then both must have had pancreatic cancer and a first-degree relationship with individual screened
  -  If there are more than 2 affected individuals on the same side of the family at least one of the individuals must have a first-degree relationship with the member being screened
  -  Patients at least 40 years old or 10 years younger than the youngest affected individual
  -  Peutz-Jeghers Syndrome (PJS) patients age>30
  -  Hereditary pancreatitis patients
  -  Patients with Familial Atypical Multiple Mole Melanoma Syndrome (FAMMM)
  -  Patients with BRCA2 mutation and at least one first or second degree relative with documented pancreatic cancer
  -  Willingness to undergo (EUS) with possible Fine Needle Aspiration (FNA)
  -  Willingness to undergo surgical evaluation for abnormal EUS/FNA finding
  -  Willingness to undergo radiographic evaluation if screening findings are abnormal
  Exclusion Criteria:
  -  Medical contraindications to undergoing endoscopy or obstruction of the GI tract that precludes passage of the endoscope
  -  Personal history of pancreatic adenocarcinoma
  -  Previous partial or complete resection of the pancreas for adenocarcinoma
  -  Prior partial or total gastrectomy with Billroth II or Roux-en-Y anastamosis
  -  Previous computed tomography (CT) scan, magnetic resonance imaging/magnetic resonance cholangiopancreatography (MRI/MRCP) or EUS of the abdomen in the past 3 years
  -  Coexisting cancer in other organs or acquired immunodeficiency syndrome/human immunodeficiency virus (AIDS/HIV)
  -  Life expectancy less than 5 years
  -  Pregnancy

Relevance to patient case: not relevant