Nasogastric Decompression Following Pancreaticoduodenectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pancreatic Head Neoplasm Delayed Gastric Emptying Post Operative Ileus Whipple Procedure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A ( No NGT)

Group Type ACTIVE_COMPARATOR

pancreaticoduodenectomy

Intervention Type 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

Group B (NGT Retained)

Group Type ACTIVE_COMPARATOR

pancreaticoduodenectomy

Intervention Type 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

Interventions

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pancreaticoduodenectomy

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

Intervention Type PROCEDURE

Other Intervention Names

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Whipple

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No