Impact of the Absence of Nasogastric Decompression After Pancreaticoduodenectomy

Study Overview
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Brief Summary
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The use of nasogastric (NG) decompression after pancreaticoduodenectomy (PD) is a current practice. NG tube is associated with a high rate of morbidity including pulmonary morbidity, delayed gastric emptying and finally an increased length of hospital stay. The absence of NG decompression could be the corner stone of the concept of the enhanced recovery program after PD.

Detailed Description
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The use of nasogastric (NG) decompression after pancreaticoduodenectomy (PD) is a current practice. NG tube is associated with a high rate of morbidity including pulmonary morbidity, delayed gastric emptying and finally an increased length of hospital stay. In the era of the enhance recovery after major abdominal surgery, the place of the NG tube remains unproven after PD even if NG tube is clearly abandoned in liver, stomach and colonic surgery. Nowadays, only few retrospective series had reported the feasibility of the absence of nasogastric tube after PD, but not with a randomized control trial. The absence of NG decompression could be the corner stone of the concept of the enhanced recovery program after PD. The objective of this prospective randomized monocentric study is to evaluate the impact of the absence of NG decompression after PD. The aim of the study is to decrease postoperative morbidity after PD including pulmonary and delayed gastric emptying complication. The impact of the absence of systematic NG decompression could be interesting in terms of public health with a decreased of length of hospital stay. Furthermore, this is the first randomized study comparing NG tube decompression after PD to absence of NG tube after PD which would bring relevant elements to improve the recovery after PD.

Official Title
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Impact of the Absence of Nasogastric Decompression After Pancreaticoduodenectomy : A Prospective and Randomized Study

Conditions
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Digestive System Surgical Procedure, Pancreaticoduodenectomy

Intervention / Treatment
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* Device: no nasogastric tube
* Device: nasogastric tube


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years and ≤ 75 years patient requiring a PD for benign of malign pathology of the bilio and pancreatic intersection patient giving free and informed consent Exclusion Criteria: previous gastric of esophagus surgery sever comorbidity such as : end stage renal disease, respiratory failure, heart failure (≥ 3 NYHA) Person with a measure of legal protection (guardianship) Pregnant woman or nursing mother

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: With Nasogastric Decompression<br>This group will receive conventional care according to the protocol of the service in place with removal of the nasogastric tube the 3rd postoperative day if the flow is < 500ml / 24h, if not removal will take place on the 5th postoperative day. | Device: nasogastric tube<br> <br> * Other names: double lumen nasogastric tube;|
| Experimental: Without Nasogastric decompression<br>The nasogastric tube will be take off at the end of the surgery, just after the extubation. | Device: no nasogastric tube<br> <br> * Other names: no double lumen nasogastric tube;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Clavien and Dindo complication ≥ grade II | during hospitalisation to demonstrate the feasibility of the absence of NG decompression after pancreaticoduodenectomy | up to five days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary complication | occurrence of pulmonary complication (including atelectasic, pleural effusion, pneumonitis | up to 90 days after surgery | 
| Gastric emptying | occurrence of gastric delayed emptying (classified to the ISGPS classification ) | up to five days after surgery | 
| Pancreatic fistula | Occurence of pancreatic fistula (classified according to the ISGPS classification) | up to 90 days after surgery | 
| Food intake | Time to oral food intake | up to five days after surgery | 
| First gas | Time to the emission of the first gas | up to five days after surgery | 
| Reinsertion of Nasogastric tube | NG tube reinsertion rate | up to five days after surgery | 
| Reinsertion of Nasogastric tube | NG tube reinsertion time | up to five days after surgery | 
| Reinsertion of Nasogastric tube | NG tube reinsertion for gastroparesis or reintubation | up to five days after surgery | 
| Mortality rate |  | up to 90 days after surgery | 
| Hospital stay | length of hospital stay | up to 90 days after surgery | 
| Readmission rate |  | up to 90 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nasogastric decompression