Impact of the Absence of Nasogastric Decompression After Pancreaticoduodenectomy
IPOD
1 other identifier
interventional
125
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2015
CompletedFirst Posted
Study publicly available on registry
November 3, 2015
CompletedStudy Start
First participant enrolled
December 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 5, 2018
CompletedFebruary 15, 2019
February 1, 2019
2.7 years
October 29, 2015
February 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (11)
Pulmonary complication
up to 90 days after surgery
Gastric emptying
up to five days after surgery
Pancreatic fistula
up to 90 days after surgery
Food intake
up to five days after surgery
First gas
up to five days after surgery
- +6 more secondary outcomes
Study Arms (2)
With Nasogastric Decompression
ACTIVE COMPARATORThis 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.
Without Nasogastric decompression
EXPERIMENTALThe nasogastric tube will be take off at the end of the surgery, just after the extubation.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Universitaire Rennes Pontchaillou
Rennes, 35000, France
Related Publications (1)
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.
PMID: 32667635DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laurent Sulpice, MD/PH/prof
Rennes UH
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2015
First Posted
November 3, 2015
Study Start
December 16, 2015
Primary Completion
September 10, 2018
Study Completion
December 5, 2018
Last Updated
February 15, 2019
Record last verified: 2019-02