Nasogastric Decompression Following Pancreaticoduodenectomy

NCT06413888 | Completed DMC

• 1 other identifier: H-43383
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• to assess whether nasogastric decompression following a whipple procedure will reduce the incidence and severity of postoperative complications

  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.

  30-days postoperatively

Secondary Outcomes (2)

• Examined the re-insertion rate of Nasogastric tube following pancreaticoduodenectomy

  30- days postoperatively

• identify factors that necessitated its use in the immediate postoperative period

  30 days postoperatively

Study Arms (2)

Group A ( No NGT)

ACTIVE COMPARATOR

Procedure: pancreaticoduodenectomy

Group B (NGT Retained)

ACTIVE COMPARATOR

Procedure: pancreaticoduodenectomy

Interventions

pancreaticoduodenectomy PROCEDURE

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

Also known as: Whipple

Group A ( No NGT); Group B (NGT Retained)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients 18 years of age or older
• Patients undergoing successful pancreaticoduodenectomy for benign or malignant neoplasm.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor college of medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Gastroparesis

Interventions

Pancreaticoduodenectomy

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Omar Barakat, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 14, 2024
• Study Start: June 1, 2018
• Primary Completion: May 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)