Clinical trial NCT06413888: Nasogastric Decompression Following Pancreaticoduodenectomy
Official title: Routine Nasogastric Drainage vs. No Drainage Using Nasogastric Tube After Pancreaticoduodenectomy: A Randomized Control Trial [NCT ID Not Yet Assigned]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Head Neoplasm
Delayed Gastric Emptying
Post Operative Ileus
Whipple Procedure
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2024-05-14
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups of patients. Group 1 patients will have NGT placed in the operating room and continued in the immediate postoperative recovery period. Group 2 patients will have oropharyngeal gastric tube inserted in the operating room and removed at the end of the procedure.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: to assess whether nasogastric decompression following a whipple procedure will reduce the incidence and severity of postoperative complications
timeFrame: 30-days postoperatively
Secondary outcomes:
measure: Examined the re-insertion rate of Nasogastric tube following pancreaticoduodenectomy
timeFrame: 30- days postoperatively
measure: identify factors that necessitated its use in the immediate postoperative period
timeFrame: 30 days postoperatively
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor college of medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Omar Barakat, MD
role: PRINCIPAL_INVESTIGATOR
References: