[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621399":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":54,"collaborators":56,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":26,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":26,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":26,"overallStatus":100,"whyStopped":26,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"routine nasogastric tube","ACTIVE_COMPARATOR","standard nasogastric tube placement with the tube retained postoperatively",[13],"Procedure: nasogastric tube decompression",{"label":15,"type":16,"description":17,"interventionNames":18},"routine omission of the nasogastric tube","EXPERIMENTAL","avoidance of prophylactic nasogastric tube placement",[19],"Procedure: Omission of nasogastric tube decompression",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","nasogastric tube decompression","Nasogastric tube decompression means standard NGT placement with the tube retained postoperatively until the drainage volume is \\\u003C500 ml\u002Fday on postoperative day 3. Nasogastric tube placement will adhere to the following requirements: pre-insertion nasal patency assessment excluding the side with septal deviation or polyps, catheter pre-measurement from the apex nasi to the ear lobe and xiphoid process, and lubrication with liquid paraffin. After advancement into the pharynx, conscious patients will undergo repeated swallowing to facilitate passage, whereas unconscious patients will require laryngeal elevation with neck flexion to prevent tracheal intubation.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Omission of nasogastric tube decompression","Omission of nasogastric tube decompression means avoidance of prophylactic NGT placement throughout the perioperative period. If intraoperative NGT insertion becomes necessary because of acute gastric dilatation, the tube should be removed before anesthesia emergence.",[15],[32],{"name":33,"affiliation":34,"role":35},"Min Wang","Department of Pancreatic and Gastric Surgery, National Cancer Centre\u002FNational Clinical Research Centre for Cancer\u002FCancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Junzhe Zhuo","CONTACT","+86 18250336385","jz.zhuo@outlook.com",[43],{"facility":44,"status":26,"city":45,"state":26,"zip":26,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":26},"National Cancer Center\u002FNational Clinical Research Center for Cancer\u002FCancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College","Beijing","China","CN",{"type":49,"coordinates":50},"Point",[51,52],116.39723,39.9075,{"lat":52,"lon":51},{"type":35,"investigatorFullName":33,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Professor; Chief Physician",[57,59,61,63,65,67,69,72,75,77],{"name":58,"class":6},"Zhejiang Provincial People's Hospital",{"name":60,"class":6},"Shanghai Cancer Centre",{"name":62,"class":6},"The Second Hospital of Hebei Medical University",{"name":64,"class":6},"People's Hospital of Chongqing",{"name":66,"class":6},"Shanghai Zhongshan Hospital",{"name":68,"class":6},"Guangdong Provincial Hospital of Traditional Chinese Medicine",{"name":70,"class":71},"Shandong Provincial Hospital","OTHER_GOV",{"name":73,"class":74},"The Second Affiliated Hospital of the Army Medical University","UNKNOWN",{"name":76,"class":6},"West China Hospital",{"name":78,"class":6},"Shanxi Province Cancer Hospital","100621399","phase-2-omitting-nasogastric-tube-decompression-in-minimally-invasive-pancreaticoduodenectomy-100621399",false,"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.","ALL","18 Years","75 Years",{"count":90,"type":91},200,"ESTIMATED","INTERVENTIONAL",[94],"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.",[97,98,99],"Pancreaticoduodenectomy","Nasogastric Tube Decompression","Minimally Invasive Surgical Procedures","NOT_YET_RECRUITING","2026-03-11",{"date":103,"type":104},"2026-03-12","ACTUAL",{"date":106,"type":91},"2026-04-01",{"date":108,"type":91},"2026-09",{"name":5,"class":6},1]