Impact of the Absence of Nasogastric Decompression After Pancreaticoduodenectomy (IPOD)

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

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.

Study Overview

• Status: Completed
• Conditions: Pancreaticoduodenectomy; Digestive System Surgical Procedure
• Intervention / Treatment: Device: nasogastric tube; Device: no nasogastric tube

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 Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35000
    • Centre Hospitalier Universitaire Rennes Pontchaillou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: With Nasogastric Decompression; 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; Other Names: double lumen nasogastric tube
Experimental: Without Nasogastric decompression; The nasogastric tube will be take off at the end of the surgery, just after the extubation.	Device: no nasogastric tube; Other Names: no double lumen nasogastric tube

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Laurent Sulpice, MD/PH/prof, Rennes UH

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2015
• Primary Completion (Actual): September 10, 2018
• Study Completion (Actual): December 5, 2018

Study Registration Dates

• First Submitted: October 29, 2015
• First Submitted That Met QC Criteria: October 30, 2015
• First Posted (Estimate): November 3, 2015

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 11, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: nasogastric decompression
• Other Study ID Numbers: RennesUH