Impact of the Absence of Nasogastric Decompression After Pancreaticoduodenectomy

Not Applicable

Completed

• Conditions: Digestive System Surgical Procedure; Pancreaticoduodenectomy
• Interventions: Device: no nasogastric tube; Device: nasogastric tube

• Registration Number: NCT02594956
• Lead Sponsor: Rennes University Hospital

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.

Study Timeline

• Study First Submitted: 2015-10-29
• Study First Submitted QC: 2015-10-30
• Study First Posted: 2015-11-03
• Study Start: 2015-12-16
• Primary Completion: 2018-09-10
• Study Completion: 2018-12-05
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-11
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Without Nasogastric decompression	no nasogastric tube	The nasogastric tube will be take off at the end of the surgery, just after the extubation.
With Nasogastric Decompression	nasogastric tube	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.

Primary Outcome Measures

Name	Time	Method
Occurrence of Clavien and Dindo complication ≥ grade II	up to five days after surgery	during hospitalisation to demonstrate the feasibility of the absence of NG decompression after pancreaticoduodenectomy

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Rennes Pontchaillou; 🇫🇷 Rennes, France