Routine Nasogastric Drainage vs. No Drainage Using Nasogastric Tube After Pancreaticoduodenectomy: A Randomized Control Trial [NCT ID Not Yet Assigned]
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Baylor College of Medicine
- Enrollment
- 230
- Locations
- 1
- Primary Endpoint
- to assess whether nasogastric decompression following a whipple procedure will reduce the incidence and severity of postoperative complications
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All patients 18 years of age or older
- •Patients undergoing successful pancreaticoduodenectomy for benign or malignant neoplasm.
Exclusion Criteria
- •Patients who does not complete the procedure due to locally advanced or metastatic disease discovered during the procedure.
- •Patient who requires prolong postoperative intubation in the postoperative period.
Arms & Interventions
Group A ( No NGT)
Intervention: pancreaticoduodenectomy (Procedure)
Group B (NGT Retained)
Intervention: pancreaticoduodenectomy (Procedure)
Outcomes
Primary Outcomes
to assess whether nasogastric decompression following a whipple procedure will reduce the incidence and severity of postoperative complications
Time Frame: 30-days postoperatively
Severity of post operative complications was graded according to the Clavien-Dindo classification system adopted for pancreaic surgery, which relies on the type of treatment used for each complication with scores range from 1-4, and any complication graded \>2 considered a major complication.
Secondary Outcomes
- identify factors that necessitated its use in the immediate postoperative period(30 days postoperatively)
- Examined the re-insertion rate of Nasogastric tube following pancreaticoduodenectomy(30- days postoperatively)
Investigators
Omar Barakat
Associate Professor
Baylor College of Medicine