NCT07321470 Complete vs. Postoperative Nasogastric Tube Omission in Pancreaticoduodenectomied Patients
| NCT ID | NCT07321470 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Taiwan University Hospital |
| Condition | Peri-ampullary Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2025-09-12 |
| Primary Completion | 2027-12-31 |
Trial Parameters
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Brief Summary
Enhanced recovery after surgery (ERAS) programs recommend early removal of a nasogastric tube ( NGT) after operation has been suggested in elective major abdominal surgery, such as colorectal3, gastric4, and hepatic surgery5. However, in spite of immediate removal after operation, NGT is still worldwide routinely inserted before major abdominal surgery. The rationale to insert NGT before operation include prevention of aspiration pneumonia during anesthesia and use for decompression of the distended stomach induced by mask bagging during anesthesia induction. However, the risk of aspiration pneumonia during intubation is so low that even American Society of Anesthesiology (ASA) guidelines for preoperative fasting guideline suggest continuing a clear carbohydrate supplement drink up to 2 hours prior to operation for decreasing the fasting period.6 Indeed, musk bagging during anesthesia occasionally will distend the stomach with air to a great extent to make the operation difficult. Besides, for anatomic reasons, the insertion of NGTs into anesthetized and intubated patients during operation for decompression of distended stomach can be very challenging.7 Therefore, in spite, distended stomach occur only occasionally and insertion of a NGT into conscious patients cause a lot of discomfort, most centers adopt policy to insert it before operation. But, it is not necessary to insert a NGT during operation for decompression of distended stomach. Instead, investigators developed a novelty method to decompress distended stomach intraoperatively by thick needler suction. With this new technique, 578 PDs have been successfully performed with complete omission of NGT (CONGT)8 and none of them needed the intraoperative insertion of NGT for decompression of encountered distended stomach. Based on the excellent results of previous study, investigators further propose a prospective randomized trial to compare complete versus postoperative omission of nasogastric tube in pancreaticoduodenectomied patients. The complete omission of NGT (CONGT) study will be a prospective, single-center randomized controlled trial with 2 groups comparing rate of postoperative complications between pancreaticoduodenectomied patients with complete (CONGT) or traditional postoperative omission of NGT (PONGTR). Key inclusion criteria will be patients between 20 and 75 years of age requiring PD for benign or malignant disease of the biliopancreatic confluence and without symptoms or signs of intestinal obstruction (such as vomiting, presence of nasogastric tube). The primary end point will be the occurrence of a Clavien-Dindo classification grade II or higher postoperative complication. The secondary outcomes will be occurrence of pulmonary complications; occurrence of delayed gastric emptying; occurrence of pancreatic fistula; occurrence of biliary fistula or hemorrhage; the need for surgical reintervention; NGT reinsertion rate; 90-day mortality rate; length of hospital stay; and the readmission rate until 90 days after surgery. 216 patients will be required to have 80 per cent power to test the non-inferiority of CONGT compared with PONGT, with a non-inferiority margin of 20 per cent. Assuming a 10 per cent dropout rate, the final planned sample size will be 240 patients. Analyses will be conducted with the intent-to-treat population. As the most destructive abdominal surgery, PD should be the last type of abdominal surgical procedure performed with CONGT because of associated highest rate of delayed gastric emptying. Therefore, positive results of this study could be implied to millions of patients undergoing abdominal surgery and avoid their NGT-insertion-associated discomfort.
Eligibility Criteria
Inclusion Criteria: * Clinical diagnosis of benign or malignant disease of the biliopancreatic confluence. * Age between 20 and 75 years of age Exclusion Criteria: * previous gastric or esophageal surgery * end-stage kidney disease (creatinine clearance, \<15 mL/min/1.73m2; to convert to mL/s/m2, multiply by 0.0167) * documented chronic respiratory disease * heart failure (New York Heart Association class III or higher) * pregnancy * nursing mothers * persons under legal protection (guardianship).