Omitting Nasogastric Tube Decompression in Minimally Invasive Pancreaticoduodenectomy

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.

NCT Number	NCT07370116
Lead Sponsor	Cancer Institute and Hospital, Chinese Academy of Medical Sciences Collaborators: Zhejiang Provincial People's Hospital, Shanghai Cancer Centre, The Second Hospital of Hebei Medical University, People's Hospital of Chongqing, Shanghai Zhongshan Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Shandong Provincial Hospital, The Second Affiliated Hospital of the Army Medical University, West China Hospital, Shanxi Province Cancer Hospital
Conditions	Pancreaticoduodenectomy, Nasogastric Tube Decompression, Minimally Invasive Surgical Procedures
Enrollment	200 participants
Start Date	2026-04-01
Primary Completion	2026-07-30 (estimated)
Study Completion	2026-09 (estimated)
Updated on ClinicalTrials.gov	2026-03-12