Impact of the Absence of Nasogastric Decompression After Pancreaticoduodenectomy

Pancreaticoduodenectomy Clinical Trial

— IPOD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02594956
• Other study ID #: RennesUH
• Status: Completed
• Phase: N/A
• Start date: December 16, 2015
• Est. completion date: December 5, 2018

Study information

• Verified date: February 2019
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: December 5, 2018
• Est. primary completion date: September 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Surgical Procedure
• Pancreaticoduodenectomy

Intervention

Device:
• no nasogastric tube

• nasogastric tube

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire Rennes Pontchaillou	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

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