Nasogastric Decompression Following Pancreaticoduodenectomy

Not Applicable

Completed

• Conditions: Pancreatic Head Neoplasm; Post Operative Ileus; Delayed Gastric Emptying; Whipple Procedure
• Interventions: Procedure: pancreaticoduodenectomy

• Registration Number: NCT06413888
• Lead Sponsor: Baylor College of Medicine

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

Not available

Study Timeline

• Study Start: 2018-06-01
• Primary Completion: 2023-05-31
• Study Completion: 2023-12-31
• Status Verified: 2024-05
• Study First Submitted: 2024-05-07
• Study First Submitted QC: 2024-05-10
• Last Update Submitted: 2024-05-10
• Study First Posted: 2024-05-14
• Last Update Posted: 2024-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B (NGT Retained)	pancreaticoduodenectomy	-
Group A ( No NGT)	pancreaticoduodenectomy	-

Primary Outcome Measures

Name	Time	Method
to assess whether nasogastric decompression following a whipple procedure will reduce the incidence and severity of postoperative complications	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 Outcome Measures

Name	Time	Method
identify factors that necessitated its use in the immediate postoperative period	30 days postoperatively	To identify preoperative factors such as obesity with BMI 30 or more, Preoperative uncontrolled diabtes, older age (over 70), gender (male/female), histroy of gastric outlet obstruction, primary diagnosis (malignant disease vs benign). Intra-operative factor such such as the length of the procedure, blood loss, any concurrent procedure such as extensive lysis of adhesions, colon resection; and postoperative factors including postoperative blood counts, phosphorus and magnesium levels, blood sugar level, and postoperative complications. These factors will be assessed using logistic regression analysis to predict the necessity of nasogastric decompression in the postoperative period following the whipple procedure.
Examined the re-insertion rate of Nasogastric tube following pancreaticoduodenectomy	30- days postoperatively	Patient will be considered to undergo nasogastric decompression with nasogastric tube if he/she demonstrated clinical evidence of postoperative ileus and delayed gastric emptying as defined according to the consensus definition proposed by the international study group of pancreatic surgery (ISGPS), the severity of which was classified into 3 grades (A,B, and C) based on clinical course and postoperative management such as the need nausea and vomiting and inability to tolerate solid oral intake by the end of the first postoperative week.

Trial Locations

Locations (1)

Baylor college of medicine; 🇺🇸 Houston, Texas, United States