Digestive System Surgical ProcedureIPODNCT02594956
Impact of the Absence of Nasogastric Decompression After Pancreaticoduodenectomy
A study testing no nasogastric tube and nasogastric tube in people with Digestive System Surgical Procedure and Pancreaticoduodenectomy, run by Rennes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Digestive System Surgical Procedure, Pancreaticoduodenectomy
- What is being tested?
- no nasogastric tube and nasogastric tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteFrance
- Study dates
- 16 Dec 2015to 5 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Universitaire Rennes Pontchaillou
Rennes, 35000
About this study
Official title: 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.
Read the 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.
- Being tested
- no nasogastric tube, nasogastric tube
- Keywords
- nasogastric decompression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no nasogastric tubeDevice
Also called no double lumen nasogastric tube
nasogastric tubeDevice
Also called double lumen nasogastric tube
| Study group | Role | What they receive |
|---|---|---|
| With Nasogastric Decompression | Active comparator | 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. Receives: Device: nasogastric tube |
| Without Nasogastric decompression | Experimental | The nasogastric tube will be take off at the end of the surgery, just after the extubation. Receives: Device: no nasogastric tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Clavien and Dindo complication ≥ grade II
during hospitalisation to demonstrate the feasibility of the absence of NG decompression after pancreaticoduodenectomy
Measured: up to five days after surgery
Secondary outcomes (11)
Pulmonary complication
occurrence of pulmonary complication (including atelectasic, pleural effusion, pneumonitis
Measured: up to 90 days after surgery
Gastric emptying
occurrence of gastric delayed emptying (classified to the ISGPS classification )
Measured: up to five days after surgery
Pancreatic fistula
Occurence of pancreatic fistula (classified according to the ISGPS classification)
Measured: up to 90 days after surgery
Food intake
Time to oral food intake
Measured: up to five days after surgery
First gas
Time to the emission of the first gas
Measured: up to five days after surgery
Reinsertion of Nasogastric tube
NG tube reinsertion rate
Measured: up to five days after surgery
Reinsertion of Nasogastric tube
NG tube reinsertion time
Measured: up to five days after surgery
Reinsertion of Nasogastric tube
NG tube reinsertion for gastroparesis or reintubation
Measured: up to five days after surgery
Mortality rate
Measured: up to 90 days after surgery
Hospital stay
length of hospital stay
Measured: up to 90 days after surgery
Readmission rate
Measured: up to 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study start16 Dec 2015
- Primary completion10 Sep 2018
- Study completion5 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Digestive System Surgical ProcedureStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Sulpice, MD/PH/prof, Principal investigator, Rennes UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594956
- Sponsor's protocol ID
- RennesUH
- Acronym
- IPOD
- Status last verified
- Feb 2019
- First submitted
- 29 Oct 2015
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 32667635
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Absence of Nasogastric Decompression After Pancreaticoduodenectomy : A Prospective and Randomized Study
- ClinicalTrials.gov ID
- NCT02594956
- Acronym / sponsor ID
- IPOD / RennesUH
- Keywords
- nasogastric decompression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 16 Dec 2015 (actual)
- Primary completion
- 10 Sep 2018 (actual)
- Study completion
- 5 Dec 2018 (actual)
- First posted
- 3 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Nasogastric Decompression | Active comparator | Device: nasogastric tubeThis 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 | Experimental | Device: no nasogastric tubeThe nasogastric tube will be take off at the end of the surgery, just after the extubation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no nasogastric tubeAlso: no double lumen nasogastric tube | Device | Without Nasogastric decompression |
| nasogastric tubeAlso: double lumen nasogastric tube | Device | With Nasogastric Decompression |
Primary outcome
Occurrence of Clavien and Dindo complication ≥ grade II
Time frame: up to five days after surgery
during hospitalisation to demonstrate the feasibility of the absence of NG decompression after pancreaticoduodenectomy
11 secondary outcomes
Pulmonary complication
Time frame: up to 90 days after surgery
Gastric emptying
Time frame: up to five days after surgery
Pancreatic fistula
Time frame: up to 90 days after surgery
Food intake
Time frame: up to five days after surgery
First gas
Time frame: up to five days after surgery
Reinsertion of Nasogastric tube
Time frame: up to five days after surgery
Reinsertion of Nasogastric tube
Time frame: up to five days after surgery
Reinsertion of Nasogastric tube
Time frame: up to five days after surgery
Mortality rate
Time frame: up to 90 days after surgery
Hospital stay
Time frame: up to 90 days after surgery
Readmission rate
Time frame: up to 90 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Derived from this study: PubMed 32667635Bergeat 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent Sulpice, MD/PH/prof principal investigator
Rennes UH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing no nasogastric tube and nasogastric tube in people with Digestive System Surgical Procedure and Pancreaticoduodenectomy, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Clavien and Dindo complication ≥ grade II (time frame: up to five days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02594956, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.