[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anastomosis-roux-en-y\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anastomosis-roux-en-y":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100602000","feasibility-and-safety-of-laparoscopic-purse-string-suture-clamp-and-multi-functional-seal-cap-for-totally-laparoscopic-radical-total-gastrectomy-100602000",false,"NCT07117812","Feasibility and Safety of Laparoscopic Purse-string Suture Clamp and Multi-functional Seal Cap for Totally Laparoscopic Radical Total Gastrectomy","Inclusion Criteria:\n\n* Age 18-80 years, regardless of gender; Histologically confirmed gastric or gastroesophageal junction (GEJ) adenocarcinoma. For GEJ cancer, only Siewert type III and type II (without requiring thoracotomy) are eligible (applicable to multiple primary cancers); Preoperative assessment by a gastrointestinal surgeon and imaging specialist confirming cStage I-III disease with eligibility for curative-intent R0 resection. Patient consents to surgery and is deemed surgically fit by the surgeon; Anticipated R0 resection achievable via total gastrectomy with D1+\u002FD2 lymphadenectomy; Expected survival ≥6 months; ECOG Performance Status (PS) score (see Appendix 2) of 0 or 1; Adequate major organ function; Body weight ≥40 kg or BMI \\>18.5 and \\\u003C30 kg\u002Fm²; No prior chemotherapy, radiotherapy, targeted therapy, or immunotherapy; Patient has read and fully understood the informed consent form and voluntarily signed it\n\nExclusion Criteria:\n\n* History of other active malignancies within the past 5 years or concurrent malignancies (except cured localized tumors such as basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate\u002Fcervix\u002Fbreast, Stage I lung\u002Fcolorectal cancer, etc.).\n\nPrevious upper abdominal surgery (excluding laparoscopic cholecystectomy). History of gastrectomy, endoscopic mucosal resection (EMR), or endoscopic submucosal dissection (ESD).\n\nRequirement for concurrent surgery for other diseases. Emergency surgery due to gastric cancer complications (bleeding, obstruction, or perforation).\n\nPlanned or prior organ\u002Fbone marrow transplantation. Blood transfusion within 2 weeks before surgery, bleeding history, or Grade ≥3 hemorrhage (CTCAE v4.0) within 4 weeks.\n\nCoagulopathy (INR \\>1.5 without anticoagulants) or use of anticoagulants (warfarin\u002Fheparin). Prophylactic low-dose warfarin (≤1 mg\u002Fday) or aspirin (≤100 mg\u002Fday) is permitted if INR ≤1.5.\n\nArterial\u002Fvenous thrombosis within 6 months (e.g., stroke, DVT, pulmonary embolism), excluding catheter-related thrombosis from prior chemotherapy.\n\nMyocardial infarction within 6 months or uncontrolled arrhythmia (QTc ≥450 ms \\[men\\]\u002F≥470 ms \\[women\\] by Fridericia's formula).\n\nNYHA Class III-IV heart failure or LVEF \\\u003C50%. Ventilatory dysfunction (FEV1 \\\u003C50% predicted). Urinary protein ≥++ or 24-hour urine protein \\>1.0 g. Clinically significant pleural\u002Fperitoneal effusion requiring intervention. HIV infection. Active tuberculosis. Non-healing wounds or incomplete fracture healing. Active\u002Fsuspected autoimmune disease (stable cases without immunosuppressants allowed).\n\nSevere autoimmune diseases (e.g., SLE, IBD), chronic diarrhea disorders, or active HBV\u002FHCV (HBV DNA \\\u003C500 copies\u002FmL permitted).\n\nSystemic corticosteroids (\\>10 mg\u002Fday prednisone equivalent) within 14 days (topical\u002Finhaled steroids or physiologic replacement doses allowed).\n\nActive infection requiring systemic antibiotics within 14 days (prophylactic antibiotics permitted).\n\nLive vaccines within 28 days (inactivated flu vaccines allowed). Concurrent participation in another surgical trial. Alcohol\u002Fdrug abuse history (abstinent patients eligible). Non-compliance or incomplete data affecting safety\u002Fefficacy assessments. Pregnancy\u002Flactation. Other conditions deemed high-risk by investigators. Investigator-determined ineligibility.","ALL","18 Years","80 Years",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23],"NA","Currently, there are three main methods for endoscopic esophagojejunostomy: circular, linear, and hand-sewn anastomosis, but no universally accepted optimal approach has been established.\n\nHand-sewn anastomosis relies on advanced endoscopic suturing skills, making it technically demanding and only performed in a limited number of hospitals.\n\nLinear anastomosis is simple to perform and the most widely used in clinical practice. However, it requires resection of a longer segment of the distal esophagus and may struggle to ensure adequate margins for high-positioned tumors or unclear resection boundaries.\n\nCircular anastomosis is a classic method. Its end-to-side approach preserves more esophageal length, making it suitable for high-positioned tumors without the need to close a common opening. Various techniques (e.g., the reverse-puncture method and the Orvil™ transoral anvil technique) have been reported. However, due to challenges such as purse-string suturing, complex anvil placement, and restricted stapler maneuverability, widespread adoption remains difficult.\n\nProf. Du Jianjun's team innovatively employed endoscopic purse-string forceps and a multifunctional sealing ring to achieve circular anastomosis, demonstrating preliminary technical advantages. This study further explores its feasibility and short-term outcomes in totally endoscopic total gastrectomy.",[26,27,28,29],"Gastric Cancer (GC)","Gastrectomy","Anastomosis, Roux-en-Y","Laparoscopic","NOT_YET_RECRUITING","2025-08-12",{"date":33,"type":34},"2025-08-15","ACTUAL",{"date":36,"type":20},"2025-09-01",{"date":38,"type":20},"2027-09-01",{"name":40,"class":41},"The First Affiliated Hospital with Nanjing Medical University","OTHER"]