NCT06413888

Nasogastric Decompression Following Pancreaticoduodenectomy

Routine Nasogastric Drainage vs. No Drainage Using Nasogastric Tube After Pancreaticoduodenectomy: A Randomized Control Trial [NCT ID Not Yet Assigned]

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Pancreaticoduodenectomy (PD) remains the gold-standard operation for peri-ampullary neoplasms. Traditionally, gastric decompression via nasogastric intubation has been employed postoperatively to prevent nausea, vomiting, aspiration pneumonia, anastomotic leakage and delayed gastric emptying. Recently, the implementation of ERAS protocol recommended against routine use of nasogastric tube following PD. however, limited data exists surrounding the identification of those patients needing NGT decompression in the immediate postoperative period. Therefore, we initiated a large prospective randomized controlled trial to evaluate the clinical outcomes of patients who retained the NGT post-PD versus those who had it removed at the end of the procedure. This study aims to assess the effectiveness of nasogastric decompression in PD recovery, with the primary endo point being the need for and impact of NGT in the postoperative recovery. The secondary endpoint will examined the re-insertion rate of NGT and identify factors that necessitate its use in the immediate postoperative period.

Conditions

• Pancreatic Head Neoplasm
• Delayed Gastric Emptying
• Post Operative Ileus
• Whipple Procedure

Interventions

Type	Name	Description
PROCEDURE	pancreaticoduodenectomy	Surgical removal of the head of the pancreas, duodenum, extrahepatic bile duct, distal stomach, and proximal jejunum. Group A cohort will not have NGT placed in the postoperative period. Whereas, group B will have the NGT retained in the posoperative period

Timeline

• Start date: 2018-06-01
• Primary completion: 2023-05-31
• Completion: 2023-12-31
• First posted: 2024-05-14
• Last updated: 2024-05-14

Locations

1 site across 1 country: United States