Safety and Feasibility of Omitting Nasogastric Decompression in Minimally Invasive Pancreaticoduodenectomy: a Multicenter Non-inferiority Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Comprehensive Complication Index
研究概览
简要总结
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.
Participants 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.
The 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/discomfort 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 years and 75 years.
- •Indication for MIPD confirmed by MDT evaluation.
- •Ability to understand trial requirements and willingness to adhere to study protocols.
- •Written informed consent obtained before registration.
- •Curative-intent treatment consistent with international clinical guidelines.
排除标准
- •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.
- •American Society of Anaesthesiologists (ASA) Physical Status ≥ IV.
- •Pregnant or breastfeeding women.
- •Severe psychiatric disorders.
- •History of other malignancy.
- •Neoadjuvant chemoradiotherapy prior to surgery.
- •Body mass index >35 kg/m
- •History of nasopharyngeal, gastric or oesophageal surgery.
- •Preoperative gastrointestinal obstruction.
- •Contraindications to nasogastric intubation, including recent caustic ingestion, oesophageal stricture/diverticulum, or maxillofacial trauma.
- •Participation in any other clinical trials within 3 months.
研究组 & 干预措施
routine nasogastric tube
standard nasogastric tube placement with the tube retained postoperatively
干预措施: nasogastric tube decompression (Procedure)
routine omission of the nasogastric tube
avoidance of prophylactic nasogastric tube placement
干预措施: Omission of nasogastric tube decompression (Procedure)
结局指标
主要结局
Comprehensive Complication Index
时间窗: 30 days postoperatively
Comprehensive Complication Index calculates a weighted sum of complications graded by the Clavien-Dindo classification that occur within 30 days postoperatively to generate a continuous score from 0 (no complications) to 100 (death), quantifying the overall postoperative complication burden
次要结局
- pancreaticoduodenectomy-specific complications(30 days postoperatively)
- abdominal complications(30 days postoperatively)
- pulmonary complications(30 days postoperatively)
- comfort(30 days postoperatively)
- Time to tolerate oral intake (liquids/solids)(Up to 90 days postoperatively)
- Hospitalization cost(90 days postoperatively)
- Mortality rate(90 days posoperatively)
- Rescue nasogastric tube insertion(90 days postoperatively)
- Length of stay(Up to 90 days postoperatively)
研究者
Min Wang
Professor; Chief Physician
Cancer Institute and Hospital, Chinese Academy of Medical Sciences