Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06413888
Status:
COMPLETED
Last Update Posted:
2024-05-14
First Post:
2024-05-07
Brief Title:
Nasogastric Decompression Following Pancreaticoduodenectomy
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Routine Nasogastric Drainage vs No Drainage Using Nasogastric Tube After Pancreaticoduodenectomy A Randomized Control Trial NCT ID Not Yet Assigned
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
whipple
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None