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Nasogastric Decompression Following Pancreaticoduodenectomy (whipple)

Baylor College of Medicine logo

Baylor College of Medicine

Status

Completed

Conditions

Pancreatic Head Neoplasm
Post Operative Ileus
Whipple Procedure
Delayed Gastric Emptying

Treatments

Procedure: pancreaticoduodenectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT06413888
H-43383

Details and patient eligibility

About

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.

Enrollment

230 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

230 participants in 2 patient groups

Group A ( No NGT)
Active Comparator group
Treatment:
Procedure: pancreaticoduodenectomy
Group B (NGT Retained)
Active Comparator group
Treatment:
Procedure: pancreaticoduodenectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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