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.
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.
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.
Parallel
nasogastric tube decompression
Procedure/SurgeryNasogastric tube decompression means standard NGT placement with the tube retained postoperatively until the drainage volume is \<500 ml/day 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.
Omission of nasogastric tube decompression
Procedure/SurgeryOmission 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.
Comprehensive Complication Index
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
pancreaticoduodenectomy-specific complications
incidence of pancreaticoduodenectomy-specific complications, defined and classified according to International Study Group of Pancreatic Surgery criteria: delayed gastric emptying, postoperative pancreatic fistula, postoperative bile leak, postpancreatectomy haemorrhage, chyle leak and major complications (Clavien-Dindo grade ≥ II)
abdominal complications
incidence of abdominal complications: surgical-site infection, intra-abdominal abscess, paralytic ileus, gastric dilatation and gastroenteric anastomotic leak
pulmonary complications
incidence of pulmonary complications, including pneumonia, pulmonary embolism, atelectasis and pleural effusion
comfort
nasogastric-tube-related discomfort scores (10-cm visual analogue scale)
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead sponsor
Zhejiang Provincial People's Hospital
Collaborator
Shanghai Cancer Centre
Collaborator
The Second Hospital of Hebei Medical University
Collaborator
People's Hospital of Chongqing
Collaborator
Shanghai Zhongshan Hospital
Collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine
Collaborator
Shandong Provincial Hospital
Collaborator
The Second Affiliated Hospital of the Army Medical University
Collaborator
West China Hospital
Collaborator
Shanxi Province Cancer Hospital
Collaborator
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