Pancreatic DiseaseNutri-DPCNCT01580527
Postoperative Artificial Nutrition After Pancreaticoduodenectomy
A study testing Total parenteral nutrition and Enteral nutrition in people with Pancreatic Disease, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Pancreaticoduodenectomy is a major surgery burdened by important morbidity and mortality partially related to the altered nutritional status of the patients. The perioperative malnutrition is a major risk factor of postoperative complications and worsens the prognosis of the patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Disease
- What is being tested?
- Total parenteral nutrition and Enteral nutrition
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2011to Mar 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients more than 18 years of age.
- Pancreatic surgery by pancreaticoduodenectomy.
- Patient affiliated to a mode of the social security or receiving of such a mode.
- Having given written informed consent prior to any procedure related to the study
Who cannot join
- ASA score ≥4
- Pregnant women
- Patient who cannot give written informed consent.
- Concomitant participation in a biomedical study being able to interfere with this research
- Patient less than 18 years of age or more than 18 years of age, protected by the Law, under guardianship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Unité de Chirurgie Hépatobiliaire et Pancréatique Hopital Edouard Herriot
Lyon, 69437
Mustapha ADHAM, Professor
About this study
Official title: A Prospective, Multicentric, Randomized Trial Comparing Early Enteral Nutrition Versus Parenteral Nutrition After Pancreaticoduodenectomy
Pancreaticoduodenectomy is a major surgery burdened by important morbidity and mortality partially related to the altered nutritional status of the patients. The perioperative malnutrition is a major risk factor of postoperative complications and worsens the prognosis of the patients. The perioperative artificial nutrition has for objectives to correct the preoperative malnutrition, and to maintain the nutritional status in the post-operative period. The current guidelines in surgery are in favour of a realisation of a perioperative artificial nutrition support that privilege the enteral nutrition. However, after pancreaticoduodenectomy, the total parenteral nutrition remains most usually used in the early postoperative period, although rare studies suggest a benefit of the enteral nutrition in term of reduction of the post-operative complications. Indeed, no recommendation was formulated concerning early enteral nutrition after pancreaticoduodenectomy because few studies were realized on its profits.
The data of the literature report rates of complications (essentially major) from 49 % to 59 % after major digestive surgery (not only pancreatic) on patients having received a total parenteral nutrition versus rates from 34 to 43.8 % in patients having received an early enteral nutrition.
Read more
A preliminary prospective study realized in the investigators centre showed a rate of 74 % complication versus 44 %, respectively in the total parenteral nutrition and early enteral nutrition groups (50 patients in every group, with p < 0.01. All the complications were listed prospectively).
Hypothesis :
The early enteral nutrition will allow, after pancreaticoduodenectomy, a decrease of, at least, 19 % complications of any stage according to the classification of Dindo-Clavien (59 % versus 40 %).
- Conditions
- Pancreatic Disease
- Being tested
- Total parenteral nutrition, Enteral nutrition
- Keywords
- postoperative artificial nutrition, parenteral nutrition, enteral nutrition, postoperative complications, cephalic pancreatoduodenectomy
- Medical subject headings
- Pancreatic Diseases, Hyperphagia, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total parenteral nutritionProcedure or surgery
Total parenteral nutrition in postoperative of pancreaticoduodenectomy
Enteral nutritionProcedure or surgery
Early enteral nutrition in postoperative of pancreaticoduodenectomy
| Study group | Role | What they receive |
|---|---|---|
| total parenteral nutrition | Active comparator | Not described Receives: Procedure: Total parenteral nutrition |
| Early enteral nutrition | Experimental | Not described Receives: Procedure: Enteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients presenting one or several postoperative complications
Data recorded during the period of hospitalization (an expected average of 3 weeks) and until control visit 3 months after surgery
Measured: 90 days
Secondary outcomes (9)
Nutritional status
weight, BMI, Index of Nutritional Risk, blood albumin and prealbumin, during the period of hospitalization (an expected average of 3 weeks) and until control visit 3 months after surgery
Measured: 90 days
Infectious complications
Percentage of patients presenting an infectious complication, and type of infectious complication
Measured: within the hospitalization time after surgery (an expected average of 3 weeks)
Evaluation of the severity of the complications
according to classification of Dindo-Clavien
Measured: within the hospitalization time after the surgery (an expected average of 3 weeks)
Pancreatic fistulas
evaluation of the occurrence of pancreatic fistulas, grade B and C, in both groups of patients
Measured: within the hospitalization time after the surgery (an expected average of 3 weeks)
Hemorrhagic complications
evaluation of the occurrence of hemorrhagic complications, grade B and C, in both groups of patients
Measured: within the hospitalization time after the surgery (an expected average of 3 weeks)
gastroparesis
defined as the presence of the nasogastric probe 10 days after the surgery
Measured: within the hospitalization time after the surgery (an expected average of 3 weeks)
Duration of hospital stay
Measured: within the hospitalization time after the surgery (an expected average of 3 weeks)
Time frame of resumption of the intestinal bowel motion
daytime of resumption of flatulencies and\or stools
Measured: within the hospitalization time after the surgery (an expected average of 3 weeks)
Time frame of resumption of the oral food and artificial nutrition weaning
Measured: within the hospitalization time after the surgery (an expected average of 3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2012 (estimated)
- Study startMar 2011
- Primary completionMar 2014 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01580527
- Sponsor's protocol ID
- 2010.627
- Acronym
- Nutri-DPC
- Status last verified
- Apr 2012
- First submitted
- 31 Jan 2012
- Last updated
- 19 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicentric, Randomized Trial Comparing Early Enteral Nutrition Versus Parenteral Nutrition After Pancreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT01580527
- Acronym / sponsor ID
- Nutri-DPC / 2010.627
- Conditions
- Pancreatic Disease
- Keywords
- postoperative artificial nutrition, parenteral nutrition, enteral nutrition, postoperative complications, cephalic pancreatoduodenectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 19 Apr 2012 (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.
Pancreaticoduodenectomy is a major surgery burdened by important morbidity and mortality partially related to the altered nutritional status of the patients. The perioperative malnutrition is a major risk factor of postoperative complications and worsens the prognosis of the patients. The perioperative artificial nutrition has for objectives to correct the preoperative malnutrition, and to maintain the nutritional status in the post-operative period. The current guidelines in surgery are in favour of a realisation of a perioperative artificial nutrition support that privilege the enteral nutrition. However, after pancreaticoduodenectomy, the total parenteral nutrition remains most usually used in the early postoperative period, although rare studies suggest a benefit of the enteral nutrition in term of reduction of the post-operative complications. Indeed, no recommendation was formulated concerning early enteral nutrition after pancreaticoduodenectomy because few studies were realized on its profits.
The data of the literature report rates of complications (essentially major) from 49 % to 59 % after major digestive surgery (not only pancreatic) on patients having received a total parenteral nutrition versus rates from 34 to 43.8 % in patients having received an early enteral nutrition.
A preliminary prospective study realized in the investigators centre showed a rate of 74 % complication versus 44 %, respectively in the total parenteral nutrition and early enteral nutrition groups (50 patients in every group, with p < 0.01. All the complications were listed prospectively).
Hypothesis :
The early enteral nutrition will allow, after pancreaticoduodenectomy, a decrease of, at least, 19 % complications of any stage according to the classification of Dindo-Clavien (59 % versus 40 %).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| total parenteral nutrition | Active comparator | Procedure: Total parenteral nutrition |
| Early enteral nutrition | Experimental | Procedure: Enteral nutrition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients more than 18 years of age.
- Pancreatic surgery by pancreaticoduodenectomy.
- Patient affiliated to a mode of the social security or receiving of such a mode.
- Having given written informed consent prior to any procedure related to the study
Key exclusion criteria (5 listed)
- ASA score ≥4
- Pregnant women
- Patient who cannot give written informed consent.
- Concomitant participation in a biomedical study being able to interfere with this research
- Patient less than 18 years of age or more than 18 years of age, protected by the Law, under guardianship
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 |
|---|---|---|
| Total parenteral nutritionTotal parenteral nutrition in postoperative of pancreaticoduodenectomy | Procedure or surgery | total parenteral nutrition |
| Enteral nutritionEarly enteral nutrition in postoperative of pancreaticoduodenectomy | Procedure or surgery | Early enteral nutrition |
Primary outcome
Percentage of patients presenting one or several postoperative complications
Time frame: 90 days
Data recorded during the period of hospitalization (an expected average of 3 weeks) and until control visit 3 months after surgery
9 secondary outcomes
Nutritional status
Time frame: 90 days
Infectious complications
Time frame: within the hospitalization time after surgery (an expected average of 3 weeks)
Evaluation of the severity of the complications
Time frame: within the hospitalization time after the surgery (an expected average of 3 weeks)
Pancreatic fistulas
Time frame: within the hospitalization time after the surgery (an expected average of 3 weeks)
Hemorrhagic complications
Time frame: within the hospitalization time after the surgery (an expected average of 3 weeks)
gastroparesis
Time frame: within the hospitalization time after the surgery (an expected average of 3 weeks)
Duration of hospital stay
Time frame: within the hospitalization time after the surgery (an expected average of 3 weeks)
Time frame of resumption of the intestinal bowel motion
Time frame: within the hospitalization time after the surgery (an expected average of 3 weeks)
Time frame of resumption of the oral food and artificial nutrition weaning
Time frame: within the hospitalization time after the surgery (an expected average of 3 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total parenteral nutrition and Enteral nutrition in people with Pancreatic Disease, run by Hospices Civils de Lyon 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 Apr 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mustapha ADHAM, Professor (+33 4 72 11 62.61, mustapha.adham@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients presenting one or several postoperative complications (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2012.