[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"billiary-track-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:billiary-track-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100636042","nutritional-intervention-implication-in-enhanced-recovery-after-surgery-for-whipple-procedure-100636042",false,"NCT07560540","Nutritional Intervention Implication in Enhanced Recovery After Surgery for Whipple Procedure","Implication of Nutritional Intervention in Enhanced Recovery After Surgery for Whipple Procedure\u002FPylorus Preserving Pancreatoduodenectomy","{ERAS}","Inclusion Criteria:\n\n* Malignancy of;\n\n  * Distal common bile duct\n  * Pancreatic head\n  * Periampullary\n  * Duodenal\n* Patients scheduled for elective Whipple's procedure (laparoscopic and open)\n* Age 18 and above\n\nExclusion Criteria:\n\n* Patients undergoing Whipple's procedure for reasons other than malignancy\n* Patients undergoing emergency procedures\n* Patients with significant preoperative complications prohibiting oral intake\n* Age below 18","ALL","18 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"NA","The objective of this research is to assess the impact of personalized nutritional intervention on postoperative complications and length of stay in Whipple's patients via assessing the parameters related to body composition, nutritional status, weight maintenance, biochemical profile (LFTs, RFTs, CBC, CRP, serum electrolytes, coagulation profile and HbA1c) and muscle preservation postoperatively. Moreover, enhanced recovery after surgery (ERAS) guidelines in Whipple's patients will also be monitored. Exactly 20 patients undergoing Whipple's Procedure\u002FPPPD in 1 year will be recruited for the study. Medical nutrition therapy will include energy intake of 25- 30 Kcal\u002Fkg body weight and protein 1.2-1.5g\u002Fkg body weight. Enteral nutrition and parenteral nutrition will be given accordingly. After discharge, patients receiving chemotherapy and patients not receiving chemotherapy will be nutritionally intervened accordingly. Follow-ups will be done in the 2nd week, 3rd month and 6th month after surgery. Data will be analyzed using SPSS version 27. To assess the significant difference among study groups t-test, repeated measure analysis of variance (ANOVA) and regression model will be applied. The level of significance will be kept at 5%. t-test for treatment groups.",[27,28,29],"Pancreatic Cancer","Ampulla of Vater Adenocarcinoma","Billiary Track Cancer","RECRUITING","2026-04-27",{"date":33,"type":34},"2026-05-01","ACTUAL",{"date":36,"type":34},"2025-12-01",{"date":38,"type":21},"2026-12",{"name":40,"class":41},"University of Veterinary and Animal Sciences, Lahore - Pakistan","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":42},"100516218","phase-2-perioperative-gemcitabine-cisplatin-and-pembrolizumab-in-potentially-resectable-biliary-tract-cancers-100516218","NCT06001658","Perioperative Gemcitabine, Cisplatin, and Pembrolizumab in Potentially Resectable Biliary Tract Cancers","Tumor Microenvironment Features of Response to Perioperative Gemcitabine, Cisplatin, and Pembrolizumab in Potentially Resectable Biliary Tract Cancers","Inclusion Criteria:\n\n* Must have a newly diagnosed, biopsy-proven biliary tract cancer (BTC) including gallbladder, intrahepatic, extrahepatic, and hilar cholangiocarcinoma.\n* Resectable BTC (biliary tract cancer)\n* Measurable disease per RECIST 1.1 as determined by the investigator.\n* Age ≥18 years.\n* ECOG (Eastern Cooperative Oncology Group) performance status ≤1 or Karnofsky ≥80\n* Patients must have adequate organ and marrow function defined by study-specified laboratory tests.\n* Patients must have adequate liver function defined by study-specified laboratory tests.\n* Patients with chronic or acute HBV or HCV infection must have disease controlled prior to enrollment.\n* Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test.\n* For both Women and Men, must use acceptable form of birth control while on study.\n* Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Receiving, or previously received, any systemic chemotherapy, or investigational agent for BTC.\n* Has received prior radiotherapy within 2 weeks of start of study intervention.\n* Patients with a history of prior treatment with anti-PD-1 and anti-PD-L1.\n* Have been diagnosed with another cancer or myeloproliferative disorder whose natural history or treatment has the potential to interfere with safety or efficacy assessment of this study's investigational drugs.\n* Has a known history of Human Immunodeficiency Virus (HIV)\u002FAIDS\n* Has active co-infection with HBV and HDV.\n* Has a diagnosis of immunodeficiency.\n* Has active autoimmune disease that has required systemic treatment in the past 2 years.\n* Systemic or topical corticosteroids at immunosuppressive doses.\n* Prior allogeneic stem cell transplantation or organ transplantation.\n* Prior tissue or organ allograft or allogeneic bone marrow transplantation, including corneal transplants.\n* Uncontrolled intercurrent active medical and\u002For psychiatric illness\u002Fsocial psychosocial problems that that would limit compliance with study requirements.\n* Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Evidence of clinical ascites.\n* Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Previously identified allergy or hypersensitivity to monoclonal antibodies or any component of the study treatment formulations.\n* Pregnant or breastfeeding.\n* WOCBP and men with female partners (WOCBP) who are not willing to use contraception.\n* Subjects unable to undergo venipuncture and\u002For tolerate venous access.\n* Patient is at the time of signing informed consent a regular user (including \"recreational use\") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol).",{"count":51,"type":21},27,[53],"PHASE2","The purpose of this study is to determine the safety of peri-operative gemcitabine, cisplatin, and pembrolizumab in patients with BTC, as well as whether the combination of gemcitabine, cisplatin, and pembrolizumab (gem\u002Fcis\u002Fpembro) is feasible and lead to pathologic responses.",[29],[57,58,59,60,61,62,63,64,65],"Biliary Tract cancer","Pembrolizumab","Gemcitabine","Cisplatin","Immunotherapy","Potentially resectable biliary tract cancer","Anti PD-L1","PD-L1","Carcinoma",{"date":67,"type":34},"2025-12-03",{"date":69,"type":34},"2024-07-08",{"date":71,"type":21},"2028-06",{"name":73,"class":41},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":17,"minAge":18,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":86,"conditions":87,"keywords":93,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":103,"locationsCount":42},"100606546","a-cell-free-dna-methylation-blood-based-test-for-biliary-tract-cancers-screening-100606546","NCT07176962","A Cell-free DNA Methylation Blood-Based Test for Biliary Tract Cancers Screening","A Cell-free DNA Methylation Liquid Biopsy for Diagnosis and Management of Biliary Tract Cancers","Inclusion Criteria Internal Training and Validation Cohorts\n\n* BTC patients\n\n  1. Willing to voluntarily participate and able to comply with study procedures; if unable to read or sign, informed consent must be signed by a legally authorized representative (LAR).\n  2. Age 18-80 years (inclusive).\n  3. Able to provide required blood samples.\n  4. Pathologically confirmed biliary tract carcinoma (TNM stage I-IV).\n  5. Stable vital signs; ECOG performance status 0-1.\n  6. Adequate organ function: AST\u002FALT ≤ 5 × ULN; Child-Pugh class A or B; WBC \\> 3 × 10⁹\u002FL; ANC ≥ 1.5 × 10⁹\u002FL; Platelets ≥ 75 × 10⁹\u002FL; Hemoglobin ≥ 90 g\u002FL; Creatinine clearance ≥ 60 mL\u002Fmin; Total bilirubin ≤ 3 × ULN.\n* Other gastrointestinal malignancies (to exclude BTC non-specific signals)\n\n  1. Voluntary participation with signed informed consent (or by LAR).\n  2. Age 18-80 years (inclusive).\n  3. Able to provide required blood samples.\n  4. Pathologically confirmed gastrointestinal malignancies other than BTC, including hepatocellular carcinoma, gastric cancer, colorectal cancer, and pancreatic cancer (TNM stage I-IV).\n  5. Stable vital signs; ECOG performance status 0-1.\n* Non-cancer participants (benign biliary disease)\n\n  1. Able to provide written informed consent.\n  2. Able to provide required blood samples.\n  3. Age 18-80 years (inclusive).\n  4. Pathologically or clinically diagnosed benign biliary diseases, including cholecystitis, cholelithiasis, choledocholithiasis, adenomyomatosis, gallbladder polyps, xanthogranulomatous cholecystitis, or primary sclerosing cholangitis.\n\nExternal Validation Cohorts\n\n* BTC patients\n\n  1. Voluntary participation with signed informed consent (or by LAR).\n  2. Imaging findings of malignant biliary stricture or mass, or serum CA19-9 \\> 100 U\u002FmL, highly suspicious for BTC, with planned surgery or biopsy for pathological confirmation.\n  3. Age 18-80 years (inclusive).\n  4. Able to provide required blood samples.\n  5. Stable vital signs; ECOG performance status 0-1.\n  6. Adequate organ function: AST\u002FALT ≤ 5 × ULN; Child-Pugh class A or B; WBC \\> 3 × 10⁹\u002FL; ANC ≥ 1.5 × 10⁹\u002FL; Platelets ≥ 75 × 10⁹\u002FL; Hemoglobin ≥ 90 g\u002FL; Creatinine clearance ≥ 60 mL\u002Fmin; Total bilirubin ≤ 3 × ULN.\n* Healthy volunteers\n\n  1. Able to provide written informed consent.\n  2. Able to provide required blood samples.\n  3. Age 18-80 years (inclusive).\n\nExclusion Criteria Training and Validation Cohorts\n\n* Cancer patients\n\n  1. Pregnant or breastfeeding women.\n  2. History of organ transplantation or prior allogeneic bone marrow\u002Fstem cell transplantation.\n  3. Blood transfusion within 7 days prior to blood collection.\n  4. History of curative cancer treatment within 3 years prior to blood collection.\n  5. Use of anti-tumor drugs within 30 days prior to blood collection.\n  6. Known bleeding disorders.\n  7. Known autoimmune diseases.\n  8. Concurrent other malignancies or multiple primary tumors.\n* Non-cancer participants\n\n  1. Pregnant or breastfeeding women.\n  2. History of organ transplantation or prior allogeneic bone marrow\u002Fstem cell transplantation.\n  3. Blood transfusion within 7 days prior to blood collection.\n  4. History of any malignant tumor.\n  5. Known bleeding disorders.\n  6. Known autoimmune diseases.\n  7. Clinically significant abnormalities on routine examination (excluding hepatitis, hepatic cysts, or benign pulmonary nodules).\n\nExternal Validation Cohorts\n\n* Cancer patients\n\n  1. Pregnant or breastfeeding women.\n  2. History of organ transplantation or prior allogeneic bone marrow\u002Fstem cell transplantation.\n  3. Blood transfusion within 7 days prior to blood collection.\n  4. History of or ongoing curative cancer treatment within 3 years prior to blood collection.\n  5. Use of anti-tumor drugs within 30 days prior to blood collection.\n  6. Known bleeding disorders or autoimmune diseases.\n  7. Concurrent other malignancies (including multiple primaries) or known cancer susceptibility gene carriers.\n  8. Pathology confirmed benign disease after biopsy\u002Fsurgery.\n  9. Failure to confirm malignancy by pathology or imaging within 42 days after blood collection, or unclear lesion site\u002Fevidence.\n  10. Special exclusion criteria:\n* Pathology confirmed precancerous lesions.\n* Any local\u002Fregional or systemic anti-tumor therapy (including surgery, radiotherapy, targeted therapy, or immunotherapy) prior to blood collection.\n* Healthy volunteers\n\n  1. Pregnant or breastfeeding women.\n  2. History of organ transplantation or prior allogeneic bone marrow\u002Fstem cell transplantation.\n  3. Blood transfusion within 7 days prior to blood collection.\n  4. History of any malignant tumor.\n  5. Known bleeding disorders or autoimmune diseases.\n  6. Clinically significant abnormalities on health examination (excluding hepatitis, hepatic cysts, or benign pulmonary nodules).",true,"80 Years",{"count":84,"type":21},1800,"OBSERVATIONAL","Biliary tract carcinoma (BTC), including gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma, ranks sixth in incidence among gastrointestinal malignancies and tenth in cancer-related mortality worldwide. Due to the lack of specific early symptoms, high malignancy, and frequent recurrence and metastasis, the rate of curative resection is only about 16.5%, and the overall 5-year survival rate is less than 5%. Early and accurate detection is therefore critical for improving patient outcomes. Circulating tumor DNA (ctDNA), a fraction of circulating free DNA (cfDNA), carries genetic and epigenetic information from tumor cells and can be detected even at the early stages of cancer development. Among various liquid biopsy biomarkers, ctDNA methylation shows particular advantages in sensitivity and specificity for early cancer detection and monitoring. This study aims to evaluate the application of cfDNA methylation liquid biopsy in the diagnosis and management of BTC.",[88,89,90,91,29,92],"Gall Bladder Cancer","Intrahepatic Cholangiocarcinoma (Icc)","Extrahepatic Cholangiocarcinoma","Hilar Cholangiocarcinoma","ctDNA",[94,95,96,29],"ctDNA methylation","Early diagnosis","Liquid biopsy","2025-09-10",{"date":99,"type":34},"2025-09-16",{"date":101,"type":34},"2020-01-01",{"date":33,"type":21},{"name":104,"class":41},"Yingbin Liu, MD, PhD, FACS"]