HepatectomyPROPILSNCT02041871
Interest of PReOPerative Immunonutrition in Liver Surgery for Cancer
A study testing Oral immunonutrition in people with Hepatectomy and Elective Hepatectomy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
To study the efficacy of preoperative immunonutrition in reducing postoperative morbidity after liver resection for cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatectomy, Elective Hepatectomy, Malignant Tumors
- What is being tested?
- Oral immunonutrition
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 399 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2013to 13 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Non cirrhotic patient
- Elective liver surgery for cancer (primary or secondary malignant tumours)
- Hepatectomy including at least 1 segment or 3 wedge resections
Who cannot join
- Liver resection for benign lesions
- Liver resection associated with biliary tract surgery
- Liver resection associated with gastro-intestinal surgery
- Cirrhosis, defined by transient elastography (Fibroscan®) or by liver biopsy
- Renal failure
- Pregnancy or nursing women
Show all 9Show fewer
- History of hypersensitivity or allergy to arginine, omega-3 fatty acids, or nucleotides
- Inability to take oral nutrition
- Mental condition rendering the subject unable to understand the nature, end-points and consequences of the trial
Trial locations and contacts
1 site in 1 country.
France1 site
AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire
Villejuif, 94800
About this study
Official title: Interest of Preoperative Immunonutrition in Liver Resection for Cancer
To study the efficacy of preoperative immunonutrition in reducing postoperative morbidity after liver resection for cancer.
Read the detailed description
Perioperative immunonutrition has been developed to improve the immuno metabolic host response and outcome in postoperative period and has been proven to be beneficial in reducing significantly postoperative infectious complications and length of hospital stay in patients undergoing elective gastrointestinal surgery for tumors. To date, the effects of preoperative oral immunonutrition (ORAL IMPACT) in non cirrhotic patients undergoing liver resection for cancer are unknown. The purpose of this study is to determine whether the administration of a short-term preoperative oral immunonutrition can reduce postoperative morbidity in non-cirrhotic patients undergoing liver resection for malignant tumours.
- Conditions
- Hepatectomy, Elective Hepatectomy, Malignant Tumors
- Being tested
- Oral immunonutrition, Placebo
- Keywords
- Liver Surgery, Hepatectomy, Immunonutrition, Cancer, Morbidity, Postoperative complication
- Medical subject headings
- Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral immunonutritionDietary supplement
Also called ORAL IMPACT
Powder 74g within 250ml of water, 3 times per day during 7 days before surgery
PlaceboDietary supplement
Powder 74g within 250ml of water, 3 times per day during 7 days before surgery
| Study group | Role | What they receive |
|---|---|---|
| Impact control | Experimental | ORAL IMPACT Powder 74g within 250ml of water, 3 times per day during 7 days before surgery Receives: Dietary Supplement: Oral immunonutrition |
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall complications classified in grade 2-3-4 or 5 by DINDO-CLAVIEN
Measured: In the first 30 postoperative days after Liver surgery
Secondary outcomes (1)
Length of hospital stay
Measured: 30 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 posted22 Jan 2014 (estimated)
- Study startSep 2013
- Primary completion13 Sep 2018
- Study completion13 Sep 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 HepatectomyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 399 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Nestlé Foundation
- Responsible party
- Sponsor
- Investigators
- Denis CASTAING, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041871
- Sponsor's protocol ID
- P120207
- Acronym
- PROPILS
- Status last verified
- Feb 2018
- First submitted
- 20 Jan 2014
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Ciacio O, Voron T, Pittau G, Lewin M, Vibert E, Adam R, Sa Cunha A, Cherqui D, Schielke A, Soubrane O, Scatton O, Salloum C, Azoulay D, Benoist S, Goyer P, Vaillant JC, Hannoun L, Boleslawski E, Agostini H, Samuel D, Castaing D. Interest of preoperative immunonutrition in liver resection for cancer: study protocol of the PROPILS trial, a multicenter randomized controlled phase IV trial. BMC Cancer. 2014 Dec 18;14:980. doi: 10.1186/1471-2407-14-980.
PubMed 25523036
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Preoperative Immunonutrition in Liver Resection for Cancer
- ClinicalTrials.gov ID
- NCT02041871
- Acronym / sponsor ID
- PROPILS / P120207
- Conditions
- Hepatectomy, Elective Hepatectomy, Malignant Tumors
- Keywords
- Liver Surgery, Hepatectomy, Immunonutrition, Cancer, Morbidity, Postoperative complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 399 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Nestlé Foundation
- Study start
- Sep 2013
- Primary completion
- 13 Sep 2018 (actual)
- Study completion
- 13 Sep 2018 (actual)
- First posted
- 22 Jan 2014 (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.
To study the efficacy of preoperative immunonutrition in reducing postoperative morbidity after liver resection for cancer.
Detailed description
Perioperative immunonutrition has been developed to improve the immuno metabolic host response and outcome in postoperative period and has been proven to be beneficial in reducing significantly postoperative infectious complications and length of hospital stay in patients undergoing elective gastrointestinal surgery for tumors. To date, the effects of preoperative oral immunonutrition (ORAL IMPACT) in non cirrhotic patients undergoing liver resection for cancer are unknown. The purpose of this study is to determine whether the administration of a short-term preoperative oral immunonutrition can reduce postoperative morbidity in non-cirrhotic patients undergoing liver resection for malignant tumours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Impact control | Experimental | Dietary Supplement: Oral immunonutritionORAL IMPACT Powder 74g within 250ml of water, 3 times per day during 7 days before surgery |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- Non cirrhotic patient
- Elective liver surgery for cancer (primary or secondary malignant tumours)
- Hepatectomy including at least 1 segment or 3 wedge resections
Key exclusion criteria (9 listed)
- Liver resection for benign lesions
- Liver resection associated with biliary tract surgery
- Liver resection associated with gastro-intestinal surgery
- Cirrhosis, defined by transient elastography (Fibroscan®) or by liver biopsy
- Renal failure
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 |
|---|---|---|
| Oral immunonutritionAlso: ORAL IMPACTPowder 74g within 250ml of water, 3 times per day during 7 days before surgery | Dietary supplement | Impact control |
| PlaceboPowder 74g within 250ml of water, 3 times per day during 7 days before surgery | Dietary supplement | Placebo |
Primary outcome
Overall complications classified in grade 2-3-4 or 5 by DINDO-CLAVIEN
Time frame: In the first 30 postoperative days after Liver surgery
1 secondary outcome
Length of hospital stay
Time frame: 30 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 11 Oct 2018.
- Derived from this study: PubMed 25523036Ciacio O, Voron T, Pittau G, Lewin M, Vibert E, Adam R, Sa Cunha A, Cherqui D, Schielke A, Soubrane O, Scatton O, Salloum C, Azoulay D, Benoist S, Goyer P, Vaillant JC, Hannoun L, Boleslawski E, Agostini H, Samuel D, Castaing D. Interest of preoperative immunonutrition in liver resection for cancer: study protocol of the PROPILS trial, a multicenter randomized controlled phase IV trial. BMC Cancer. 2014 Dec 18;14:980. doi: 10.1186/1471-2407-14-980.
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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.
Denis CASTAING, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral immunonutrition in people with Hepatectomy and Elective Hepatectomy, run by Assistance Publique - Hôpitaux de Paris 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 9 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 11 Oct 2018. 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. Some participants in this study may receive a placebo. 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?
Overall complications classified in grade 2-3-4 or 5 by DINDO-CLAVIEN (time frame: In the first 30 postoperative days after Liver 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 NCT02041871, 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 11 Oct 2018.