Clinical trial NCT02594956: Impact of the Absence of Nasogastric Decompression After Pancreaticoduodenectomy
Official title: Impact of the Absence of Nasogastric Decompression After Pancreaticoduodenectomy : A Prospective and Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Digestive System Surgical Procedure
Pancreaticoduodenectomy
Keywords: nasogastric decompression
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of Clavien and Dindo complication ≥ grade II
timeFrame: up to five days after surgery
Secondary outcomes:
measure: Pulmonary complication
timeFrame: up to 90 days after surgery
measure: Gastric emptying
timeFrame: up to five days after surgery
measure: Pancreatic fistula
timeFrame: up to 90 days after surgery
measure: Food intake
timeFrame: up to five days after surgery
measure: First gas
timeFrame: up to five days after surgery
measure: Reinsertion of Nasogastric tube
timeFrame: up to five days after surgery
measure: Reinsertion of Nasogastric tube
timeFrame: up to five days after surgery
measure: Reinsertion of Nasogastric tube
timeFrame: up to five days after surgery
measure: Mortality rate
timeFrame: up to 90 days after surgery
measure: Hospital stay
timeFrame: up to 90 days after surgery
measure: Readmission rate
timeFrame: up to 90 days after surgery
Other outcomes:
Locations:
city: Rennes
country: France
facility: Centre Hospitalier Universitaire Rennes Pontchaillou
Study officials:
affiliation: Rennes UH
name: Laurent Sulpice, MD/PH/prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bergeat D, Merdrignac A, Robin F, Gaignard E, Rayar M, Meunier B, Beloeil H, Boudjema K, Laviolle B, Sulpice L. Nasogastric Decompression vs No Decompression After Pancreaticoduodenectomy: The Randomized Clinical IPOD Trial. JAMA Surg. 2020 Sep 1;155(9):e202291. doi: 10.1001/jamasurg.2020.2291. Epub 2020 Sep 16.