[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pancreaticoduodenectomy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pancreaticoduodenectomy":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,41,66,96,128,148,174,201],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100525548","phase-3-postoperative-anti-infective-strategy-following-pancreaticoduodenectomy-in-patients-with-preoperative-biliary-stent-100525548",false,"NCT06123169","Postoperative Anti-infective Strategy Following Pancreaticoduodenectomy in Patients With Preoperative Biliary Stent","FRENCH24 ANIS","Inclusion Criteria:\n\n* Planned pancreaticoduodenectomy for periampullary neoplasms\n* Endoscopic or radiological pre-operative biliary drainage\n* Age ≥ 18 years old\n* Patient able to comply with the study protocol, in the investigator's judgment\n* Patient affiliated with, or beneficiary of a social security (national health insurance) category\n* Person of full age having read and understood the information letter and signed the consent form\n* Women of childbearing potential (a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile) with hightly effective contraception (Cf. CTFG) combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system ( IUS), bilateral tubal occlusion, vasectomised partner, sexual abstinence) since 1 month and during the duration of the study and a negative blood pregnancy test by beta-HCG at inclusion.\n* Women permanently sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy.\n* Postmenopausal women: A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.\n\nExclusion Criteria:\n\n* Contraindication to PIPERACILLIN\u002FTAZOBACTAM PANPHARMA 4g \u002F 500mg powder for solution for injection in accordance with its SmPC\n* Patients allergic to beta-lactam antibiotics\n* Others pancreatic resection\n* Absence of preoperative biliary drainage\n* Surgical or anaesthesiological contra-indications:\n* non-controlled congestive heart failure - non-treated angina - recent myocardial infarction (in the previous year) - non-controlled AHT (SBP \\>160 mm or DBP \\> 100 mm, despite optimal drug treatment), long QT\n* major non-controlled infection\n* severe liver failure\n* Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent\n* Any significant disease, which, in the investigator's opinion, would exclude the patient from the study\n* Pregnant or parturient or breastfeeding woman or absence of contraceptionn\n* Person deprived of liberty by administrative or judicial decision or person placed under judicial protection, under guardianship or supervision\n* Simultaneous participation in another interventional research with the same primary endpoint.","ALL","18 Years",{"count":19,"type":20},326,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The main objective of the study is to compare 2 broad-spectrum antibiotic (Piperacillin \u002F Tazobactam) treatment modalities, following pancreaticoduodenectomy in patients with preoperative biliary stent, to demonstrate the superiority of a 5-day post-operative antibiotic therapy to antibiotic prophylaxis on the occurrence of surgical site infections (SSI)",[26,27],"Pancreaticoduodenectomy","Antibiotherapy","NOT_YET_RECRUITING","2026-06-05",{"date":31,"type":32},"2026-06-09","ACTUAL",{"date":34,"type":20},"2026-07",{"date":36,"type":20},"2028-09",{"name":38,"class":39},"University Hospital, Rouen","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":40},"100621399","phase-2-omitting-nasogastric-tube-decompression-in-minimally-invasive-pancreaticoduodenectomy-100621399","NCT07370116","Omitting Nasogastric Tube Decompression in Minimally Invasive Pancreaticoduodenectomy","Safety and Feasibility of Omitting Nasogastric Decompression in Minimally Invasive Pancreaticoduodenectomy: a Multicenter Non-inferiority Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age between 18 years and 75 years.\n2. Indication for MIPD confirmed by MDT evaluation.\n3. Ability to understand trial requirements and willingness to adhere to study protocols.\n4. Written informed consent obtained before registration.\n5. Curative-intent treatment consistent with international clinical guidelines.\n\nExclusion Criteria:\n\n1. Requirement of partial or total pancreatectomy or other palliative procedures, or presence of distant metastases (peritoneal, hepatic, distant nodal, or other organ involvement); therefore, these patients are not candidates for MIPD.\n2. American Society of Anaesthesiologists (ASA) Physical Status ≥ IV.\n3. Pregnant or breastfeeding women.\n4. Severe psychiatric disorders.\n5. History of other malignancy.\n6. Neoadjuvant chemoradiotherapy prior to surgery.\n7. Body mass index \\>35 kg\u002Fm2.\n8. History of nasopharyngeal, gastric or oesophageal surgery.\n9. Preoperative gastrointestinal obstruction.\n10. Contraindications to nasogastric intubation, including recent caustic ingestion, oesophageal stricture\u002Fdiverticulum, or maxillofacial trauma.\n11. Participation in any other clinical trials within 3 months.","75 Years",{"count":50,"type":20},200,[52],"PHASE2","This study will evaluate two perioperative nasogastric tube strategies in patients undergoing laparoscopic pancreatoduodenectomy. The goal is to determine whether routine omission of a nasogastric tube is not worse than routine nasogastric tube placement in terms of overall complications and postoperative recovery.\n\nParticipants will be randomly assigned to one of two groups. Each group will receive the assigned nasogastric tube strategy during and after surgery, and will be followed during the hospital stay and after discharge for up to postoperative 90 days. Information will be collected from routine clinical care, including discomfort score, symptoms, imaging or laboratory tests when clinically indicated, and postoperative outcomes.\n\nThe main outcome of this study is the overall burden of postoperative complications within 30 days after surgery, measured using the Comprehensive Complication Index, which summarizes all complications into a single score. Secondary outcomes include rates of pancreas surgery-specific complications (such as delayed gastric emptying, pancreatic fistula, bile leak, bleeding, and chyle leak), other abdominal and pulmonary complications, and organ dysfunction (including kidney injury, sepsis, and new cardiac dysfunction). The study will also evaluate patient discomfort related to the nasogastric tube (pain\u002Fdiscomfort scores), the need for nasogastric tube reinsertion, postoperative recovery milestones (ability to resume oral intake and length of hospital stay), healthcare costs, and all-cause mortality at 30 and 90 days after surgery.",[26,55,56],"Nasogastric Tube Decompression","Minimally Invasive Surgical Procedures","2026-03-11",{"date":59,"type":32},"2026-03-12",{"date":61,"type":20},"2026-04-01",{"date":63,"type":20},"2026-09",{"name":65,"class":39},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":74,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":40},"100621466","phase-2-prevention-of-postoperative-pancreatic-fistula-following-pancreaticoduodenectomy-by-preoperative-radiotherapy--a-phase-2-trial-100621466","NCT07370987","Prevention of Postoperative Pancreatic Fistula Following Pancreaticoduodenectomy by Preoperative Radiotherapy : a Phase 2 Trial","Prevention of Postoperative Pancreatic Fistula Following Pancreaticoduodenectomy by Preoperative Radiotherapy: a Phase 2 Trial","PreFiR","Inclusion Criteria:\n\n* Aged ≥ 45 years old\n* Candidate for pancreaticoduodenectomy by laparotomy\n* Body mass index (BMI) ≥ 25kg\u002Fm2\n* Diameter of main pancreatic duct (MPD) \\\u003C 3 mm on preoperative CT scan or MRI at the isthmus of the pancreas (future pancreatic section area)\n* Affiliation to a social security system (AME excepted)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Surgery indication : Chronic pancreatitis\n* Surgery indication : Pancreatic ductal adenocarcinoma\n* History of syndromic or hereditary pancreatic tumor\n* Contraindication to pancreaticoduodenectomy\n* Planned multivisceral resection involving organs or parts of organs not normally involved in pancreatico-duodenectomy\n* Planned external drainage of the main pancreatic duct at the end of the surgery\n* Neoadjuvant treatment planned or performed by chemotherapy or radiotherapy\n* History of chronic hepatitis (F3) or cirrhosis (F4)\n* Contraindication to radiotherapy\n* Previous history of abdominal radiotherapy\n* Extended pancreatic resection on the left beyond the radiotherapy area (left of the pancreatic isthmus)\n* History of complicated peptic ulcer\n* Patient treated for less than 4 weeks for an ulcer\n* History of pancreatic surgery\n* Ongoing pregnancy (confirmed by a test beta-HCG) or breast feeding or absence of birth control\n* Patients with a active pathology or history that may interfere with the study in progress or the interpretation of its results according to the investigator\n* Patients with a history or suspicion of non-compliance with medical regimens or will be unable to complete the entire study\n* Treatment with systemic corticosteroids (excluding inhaled corticosteroids)\n* Participation in another interventional clinical study (RIPH1, clinical investigation or clinical trial) or exclusion period set after the study\n* Protected persons under legal guardianship or conservatorship","45 Years",{"count":76,"type":20},50,[52],"Design of the study Prospective, single arm, multicentric, phase II open trial Number of participating sites 14 French centers of HPB Surgery departments associated with 14 Radiation Oncology Departments.\n\nImplementation of the study A screening of eligible patients will be made locally by the referring surgeon of each centre based on patient medical records.\n\n* Inclusion visit at the first surgical consultation (W-3 to D1) (V0) The inclusion visit will be done by the surgeon within 3 weeks before the first radiation oncologist visit\n* D1 (V1): first radiation oncologist visit\n* W2 (+\u002F- 3D) and W4 (+\u002F- 3D) (V2 et V3): Preoperative simulation process and treatment delivery\n* A first visit at W+2 (+\u002F- 3 D) will be mandatory to validate the positioning of the target volume by CBCT with IV constrast or MRI\n* Then to start of the administration of radiotherapy at W+4 (+\u002F- 3 D): Radiotherapy with 20 Gy, in 2 fraction of 10Gy with a one-day gap, so over a total period of 3\n\nW9 ( +\u002F- 1W) (V4): post-radiotherapy follow-up\n\n\\- Preoperative visit Day-1 before PD (V5)\n\nW10 (+\u002F- 1W) (V6):\n\n* Pancreaticoduodenectomy and post operative hospitalisation W14 (+\u002F- 1W) (V7): follow up with surgeon (30 days after pancreaticoduodenectomy)\n* W22 (+\u002F-1W) (V8): follow up with surgeon (90 days after pancreaticoduodenectomy)\n* W34 (+\u002F-1W) (V9): Last study visit (radiation oncologist) (6 months after pancreaticoduodenectomy) Medical follow-up by radiation oncologist at 6 months after surgery to assess the occurrence of potential late toxicities due to radiotherapy",[80,26],"Pancreatic Fistula",[82,83,84,85],"Pancreatic fistula","Surgery","pancreaticoduodenectomy","Radiotherapy","RECRUITING","2026-01-22",{"date":89,"type":32},"2026-01-27",{"date":91,"type":20},"2026-02",{"date":93,"type":20},"2027-11",{"name":95,"class":39},"Assistance Publique - Hôpitaux de Paris",{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":104,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":107,"conditions":108,"keywords":112,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":40},"100610663","phase-2-pancreatic-parenchymal-injection-of-n-butyl-2-cyanoacrylate-100610663","NCT07230509","Pancreatic Parenchymal Injection of N-butyl-2-cyanoacrylate","Efficacy of Pancreatic Parenchymal N-Butyl-2-Cyanoacrylate Injection in Pancreaticojejunostomy After Pancreaticoduodenectomy: A Randomized Controlled Trial","NBCA","Inclusion Criteria:\n\n* Patients undergoing pancreaticoduodenectomy for malignant lesions meeting the curative treatment intent in accordance with clinical guidelines.\n* Soft pancreatic texture.\n* Small main pancreatic duct diameter (\\\u003C3 mm).\n* Informed consent obtained.\n\nExclusion Criteria:\n\n* Known hypersensitivity to cyanoacrylate or Lipiodol®.\n* Extremely hard, fibrotic pancreas.\n* Significant pancreatitis involving the pancreatic remnant.\n* Active infection at the surgical site.\n* Uncontrolled coagulopathy.\n* Unfit patients for surgery due to severe medical illness.\n* Inoperable patients with distant metastases, including peritoneal, liver, distant lymph node metastases, and involvement of other organs.\n* Irresectable tumors in diagnostic laparoscopy.\n* Patients requiring left, central or total pancreatectomy or other palliative surgery.\n* Pregnant or breastfeeding women.\n* Patients with serious mental disorders.\n* Patients with vascular invasion and requiring vascular resection.\n* Patients refused to participate in the study.",{"count":105,"type":20},90,[52],"This randomized controlled trial investigates the safety and efficacy of injecting N-butyl-2- cyanoacrylate (Histoacryl®) into the pancreatic parenchyma during pancreaticoduodenectomy (PD) to enhance the security of the pancreaticojejunostomy (PJ) anastomosis and reduce postoperative pancreatic fistula (POPF) rates.",[26,109,110,111],"Postoperative Pancreatic Fistula","Pancreas Cancer","Periampullary Cancer",[113,114,115,116,117,118],"Pancreatic surgery","Anastomotic leak","Tissue adhesive","Postoperative Pancreatic Fistula (POPF)","Pancreaticoduodenectomy (PD)","Pancreaticojejunostomy (PJ)","2025-11-30",{"date":121,"type":32},"2025-12-02",{"date":123,"type":32},"2025-12-01",{"date":125,"type":20},"2027-12-20",{"name":127,"class":39},"Minia University",{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":134,"targetDuration":4,"studyType":21,"phases":136,"briefSummary":138,"conditions":139,"keywords":140,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":145,"leadSponsor":147,"locationsCount":40},"100603132","phase-1-salehs-technique-for-pancreaticojejunostomy-pancreatic-parenchymal-injection-of-n-butyl-2-cyanoacrylate-100603132","NCT07132541","Saleh's Technique for Pancreaticojejunostomy (Pancreatic Parenchymal Injection of N-butyl-2-cyanoacrylate)","Pancreatic Parenchymal Injection of N-Butyl-2-Cyanoacrylate for Pancreaticojejunostomy After Pancreaticoduodenectomy: A Novel Technique",{"count":135,"type":20},30,[137],"PHASE1","This study investigates the safety and efficacy of injecting N-butyl-2-cyanoacrylate (Histoacryl®) into the pancreatic parenchyma during pancreaticoduodenectomy (PD) to enhance the security of the pancreaticojejunostomy (PJ) anastomosis and reduce postoperative pancreatic fistula (POPF) rates.",[26,109,110,111],[113,114,115,116,117,118],"2025-08-25",{"date":143,"type":32},"2025-09-02",{"date":141,"type":32},{"date":146,"type":20},"2026-09-25",{"name":127,"class":39},{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":16,"minAge":155,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":21,"phases":158,"briefSummary":160,"conditions":161,"keywords":164,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":40},"100594278","eras-program-implementation-for-mipd-100594278","NCT07017361","ERAS Program Implementation for MIPD","A Multicenter Randomized Prospective Study on Establishing an ERAS Program and Optimized Clinical Protocol for Patients Undergoing Minimally Invasive Pancreatoduodenectomy (MIPD)","Inclusion Criteria:\n\n* Age ≥ 19 years, scheduled for standard minimally invasive (robotic or laparoscopic) pancreatoduodenectomy for periampullary tumors\n* ECOG performance status of 0 or 1 at screening\n* Able to provide written informed consent, understand study procedures, and complete patient-reported questionnaires\n* ASA physical status classification I-III\n\nExclusion Criteria:\n\n* Hypersensitivity to fentanyl or ropivacaine\n* Cognitive impairment preventing independent use of patient-controlled analgesia or completion of questionnaires\n* Major internal medical or psychiatric disorders affecting treatment response\n* Severe hepatic or renal dysfunction\n* Any condition deemed inappropriate for study participation by the investigator","19 Years",{"count":157,"type":20},140,[159],"NA","To evaluate the impact of an Enhanced Recovery After Surgery (ERAS) program on postoperative recovery in patients undergoing minimally invasive pancreatoduodenectomy (MIPD)",[26,162,163],"ERAS","Minimally Invasive Surgery",[26,162,163],"2025-06-14",{"date":167,"type":32},"2025-06-17",{"date":169,"type":20},"2025-07-15",{"date":171,"type":20},"2027-12-31",{"name":173,"class":39},"Seoul National University Hospital",{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":181,"enrollmentInfo":182,"targetDuration":4,"studyType":21,"phases":184,"briefSummary":185,"conditions":186,"keywords":187,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":40},"100540887","impact-of-external-drainage-of-the-main-pancreatic-duct-and-common-bile-duct-on-pancreatic-fistula-following-pancreaticoduodenectomy-100540887","NCT06322680","Impact of External Drainage of the Main Pancreatic Duct and Common Bile Duct on Pancreatic Fistula Following Pancreaticoduodenectomy","The Impact of External Drainage of the Main Pancreatic Duct and Common Bile Duct on Pancreatic Fistula Following Pancreaticoduodenectomy: A Multi-center Prospective Randomized Controlled Phase Clinical Trial","Inclusion Criteria:\n\n* Signed informed content obtained prior to treatment\n* Age ≥ 18 years and ≤ 80 years\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Life expectancy ≥12 weeks and ASA score ≤2.\n* Based on clinical symptoms, imaging examinations, tumor markers, and other auxiliary examinations, the clinical diagnosis includes but is not limited to tumors of the pancreatic head, ampulla of Vater, duodenum, and distal common bile duct, requiring pancreaticoduodenectomy.\n* No serious dysfunction in blood system, heart, lung function, or autoimmune system (refer to the respective diagnostic criteria)\n* White blood cell (WBC) ≥ 3 × 109\u002FL; Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL; Platelets (PLT) ≥ 100 × 109\u002FL; Hemoglobin (Hgb) ≥ 90 g\u002FL\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]\u002F alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase \\[SGPT\\]) ≤ 2.5 × institutional upper limit of normal (ULN); Total bilirubin (TBIL) ≤ ULN; Creatinine (CRE) ≤ 1.5 × ULN\n* Prothrombin time (PT) and international normalized ratio (INR) ≤ 1.5 × ULN\n* Able to comply with research visit plans and other protocol requirements.\n* With intermediate or high risk of postoperative pancreatic fistula (POPF) according to alternative fistula risk scoring system (A-FRS)\n\nExclusion Criteria:\n\n* Cancer in late stage including distant organ metastasis (liver, lung, peritoneum), metastasis to the hilar bile duct and hepatic duct, extensive metastasis to the hepatic portal lymph nodes, tumor invasion of the superior mesenteric artery, celiac trunk, inferior vena cava, or abdominal aorta.\n* Heart Failure: Congestive heart failure with New York Heart Association (NYHA) heart function classification of 3 or 4.\n* Uncontrolled Hypertension:\n* Renal Failure: Renal failure or insufficiency requiring hemodialysis or peritoneal dialysis.\n* Active Infection: Serious active clinical infection (\\> Grade 2, NCI-CTCAE version 4.0).\n* Pregnancy or Lactation: Pregnant or lactating women.\n* Major Surgery: Patients who have undergone major surgery within 4 weeks of starting the trial or have not recovered from the side effects of such surgery.\n* Other Malignancies: Combined with other malignant tumors (patients who have been cured 3 years ago can be included).\n* Upper Gastrointestinal Bleeding: Excluding patients with upper gastrointestinal bleeding within 4 weeks before surgery or with a clear tendency of gastrointestinal bleeding that cannot be corrected by active medical treatment.\n* Poor Compliance: Poor compliance, unable or unwilling to sign informed consent.","80 Years",{"count":183,"type":20},322,[159],"Pancreaticoduodenectomy (PD) is the standard treatment for tumors of the pancreatic head, distal bile duct, duodenum, and ampulla of Vater. With advances in surgical experience and instrumentation, the mortality rate of PD has decreased to below 5% in high-volume pancreatic centers. However, the postoperative complication rate remains high at 25%-50%, limiting the development and application of PD.\n\nThe main postoperative complications of PD are postoperative pancreatic fistula (POPF), delayed gastric emptying (DGE), post-pancreatectomy hemorrhage (PPH), and biliary leakage (BL). POPF, BL, and the subsequent abdominal infection, PPH, etc. are the main causes of death during hospitalization. Even in large, relatively mature pancreatic centers, the incidence of POPF remains as high as 10%-40%. In recent years, various methods have been used to prevent and treat POPF and BL after PD, such as pancreatic duct stent external drainage and external biliary drainage.\n\nTo date, there have been many studies by domestic and foreign scholars on the advantages and disadvantages of biliary and pancreatic duct external drainage versus internal drainage in PD in terms of perioperative POPF incidence, mortality rate, etc., but the research results are not consistent. Overall, pancreatic duct stent external drainage is only recommended for patients with a high risk of pancreatic fistula during PD. Currently, there have been a few relevant studies exploring and verifying the preventive effect of pancreatic duct stent external drainage on pancreatic fistula in patients with high risk of pancreatic fistula. For example, a retrospective study of 98 patients with soft pancreatic parenchyma by Teruyuki Usub et al. found that there was no significant difference between groups with and without pancreatic duct stent in preventing pancreatic fistula. However, due to the low level of evidence, only a few risk factors such as pancreatic texture and pancreatic duct diameter were included, and the risk of POPF was not systematically evaluated. Further clinical exploration and verification are needed. In 2013, Mark P Callery et al. proposed a pancreatic fistula risk score (The fistula risk score, FRS) based on the pancreatic fistula standard defined by the International Pancreatic Fistula Study Group, which included pancreatic texture, pathological type, pancreatic duct diameter, and intraoperative blood loss. This model can be used to systematically and quantitatively evaluate the risk of POPF. Previous studies did not have a clear stratification for patients undergoing pancreatic duct stent external drainage, which may have included too many patients with a low risk of pancreatic fistula, resulting in inaccurate results. Therefore, it is necessary to re-evaluate the effectiveness of pancreatic duct stent external drainage in preventing clinically relevant pancreatic fistula based on stratification of pancreatic fistula risk and disease type. At the same time, pancreatic juice contains a variety of digestive enzymes, of which pancreatic lipase, trypsin, and chymotrypsin all need to be activated by bile to play a role in digesting and decomposing fat and protein. Theoretically, biliary and pancreatic juice diversion may be able to reduce the incidence of pancreatic fistula and its related complications in PD patients.\n\nThus, the investigators design the present study to evaluate the impact of main pancreatic duct and biliary duct external drainage on postoperative complication, especially POPF.",[26],[26,188,189,190,191],"postoperative pancreatic fistula","delayed gastric emptying","post-pancreatectomy hemorrhage","biliary leakage","2025-01-19",{"date":194,"type":32},"2025-01-22",{"date":196,"type":32},"2024-05-24",{"date":198,"type":20},"2027-02-01",{"name":200,"class":39},"Shanghai Zhongshan Hospital",{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":208,"targetDuration":4,"studyType":21,"phases":209,"briefSummary":210,"conditions":211,"keywords":214,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":40},"100346055","comparing-laparoscopic-and-open-surgery-for-pancreatic-carcinoma-100346055","NCT03785743","Comparing Laparoscopic and Open Surgery for Pancreatic Carcinoma","Total Laparoscopic Pancreaticoduodenectomy Versus Open Pancreaticoduodenectomy for Pancreatic Carcinoma(TJDBPS07) a Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age between 18 years and 75 years.\n2. Histologically confirmed PDAC or clinically diagnosed PDAC by an MDT without histopathologic evidence.\n3. Patients feasible to undergo both LPD and OPD according to MDT evaluations.\n4. Patients understanding and willing to comply with this trial.\n5. Provision of written informed consent before patient registration.\n6. Patients meeting the curative treatment intent in accordance with clinical guidelines.\n\nExclusion Criteria:\n\n1. Patients with distant metastases, including peritoneal, liver, distant lymph node metastases, and involvement of other organs.\n2. Patients requiring left, central or total pancreatectomy or other palliative surgery.\n3. Preoperative American Society of Anaesthesiologists (ASA) score ≥ 4.\n4. History of other malignant disease.\n5. Pregnant or breast-feeding women.\n6. Patients with serious mental disorders.\n7. Patients treated with neoadjuvant therapy.\n8. Patients with vascular invasion and requiring vascular resection as evaluated by the MDT team according to abdominal imaging data.\n9. Body mass index \\> 35 kg\u002Fm2.\n10. Patients participating in any other clinical trials within 3 months.",{"count":50,"type":20},[159],"Background: Pancreatic cancer (PC) is one of the most aggressive malignant neoplasms with poor outcomes. Pancreatoduodenectomy (PD) is the only curative treatment for PC. Minimally invasive surgery has been progressively developed, first with the advent of hybrid-laparoscopy and recently with the total laparoscopy surgeries, but a number of issues are currently being debated, including the superiority between total laparoscopic pancreaticoduodenectomy (TLPD)and the open pancreaticoduodenectomy (OPD). Studies comparing these two surgery techniques are merging and randomized controlled trials (RCT) are lacking but clearly required.\n\nMethods\u002Fdesign: TJDBPS07 is a multicenter prospective, randomized controlled, trial comparing TLPD and OPD in pancreatic cancers. A total of 200 patients with pancreatic cancer underwent PD will be randomly allocated to the TLPD group or OPD group with an enhanced recovery after surgery (ERAS) pattern. The trial's aim is to exploring the overall survival (OS), disease free survival (DFS) and quality of life. The duration of the entire trial is seven years including prearrangement, a presumably five-year follow-up and analyses.\n\nDiscussion: Despite the fact there are several RCTs comparing minimally invasive pancreaticoduodenectomy (MIPD) and Open approach or LPD versus OPD. This trial will be the first comparing TLPD and OPD in a large multicenter setting. TJDBPS01 trial is hypothesized to assess whether TLPD has superiority over OPD in recovery and other aspects.",[212,213,26],"Pancreatic Carcinoma","Laparoscopic",[212,213,26,215],"Survival","2022-02-27",{"date":218,"type":32},"2022-03-02",{"date":220,"type":32},"2019-03-01",{"date":222,"type":20},"2027-05-01",{"name":224,"class":39},"Tongji Hospital"]