Intestinal Failure With a Temporary High-output Double EnterostomyFRYNCT02792543
Impact of Chyme Reinfusion Compared to Parenteral Nutrition on the Incidence of Complications in Patients With a Temporary High-output Double Enterostomy: a Multicentre Randomized Controlled Trial - FRY: efFiciency of Reinfusion of chYme - (FRY)
A study testing Entéromate™ and parenteral nutrition in people with Intestinal Failure With a Temporary High-output Double Enterostomy, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
In the case of intestinal failure with a high-output double enterostomy, the parenteral nutrition (PN) is the gold standard treatment until the surgical reestablishment of digestive continuity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intestinal Failure With a Temporary High-output Double Enterostomy
- What is being tested?
- Entéromate™ and parenteral nutrition
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2017to Sep 2020
- 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
- Aged over 18 years
- Temporary high-output double enterostomy (≥1500ml/24 hours)
- Total small bowel length ≥ 120 cm
- Downstream small bowel consisting of at least 25 cm of healthy bowel, accessible by a stoma, and suitable for chyme reinfusion
- Oral feeding resumed for at least 5 days
- Parenteral nutrition or hydration required until the surgical reestablishment of digestive continuity
Show all 9Show fewer
- Affiliation to an health insurance (general Social Security scheme or an equivalent scheme)
- No current or planned participation in another biomedical research
- Signature of an informed consent form
Who cannot join
- Expected duration of parenteral nutrition or chyme reinfusion less than 2 weeks
- Refusal by the patient to have a mixed texture diet,
- Chemotherapy or radiotherapy before the surgical reestablishment of digestive continuity,
- Not drained intra-abdominal collection,
- Fever, uncontrolled infection, or infection treated for less than 72 hours,
- Shock of any cause,
- Creatinine clearance ≤ 60 ml/min
- Patients under guardianship.
Trial locations and contacts
1 site in 1 country.
France1 site
Hospices Civils de Lyon - Hôpital de la Croix Rousse
Lyon, 69004
Cécile CHAMBRIER, MD, + 33 4 26 73 26 59, cecile.chambrier@chu-lyon.fr
Amélie ZELMAR, + 33 4 72 11 51 15, amelie.zelmar@chu-lyon.fr
About this study
In the case of intestinal failure with a high-output double enterostomy, the parenteral nutrition (PN) is the gold standard treatment until the surgical reestablishment of digestive continuity. PN has its own morbidity, and in the absence of expertise, the risks of infectious, mechanical, and metabolic complications are increased. Chyme reinfusion (CR) is an enteral nutritional technique which reestablishes the functional continuity of the anatomically present small bowel through an extracorporeal circulation of the chyme. In patients with intestinal failure with a temporary high-output double enterostomy, we hypothesize that CR, compared to PN will reduce post-operative complications after surgical reestablishment of digestive continuity, maintain the intestinal function including absorption, and reduce the complications during the transitional period pending the surgical reestablishment of digestive continuity.
- Being tested
- Entéromate™, parenteral nutrition
- Keywords
- nutrition, double enterostomy, chyme reinfusion, randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entéromate™Device
Also called chyme reinfusion
Chyme reinfusion (the experimental treatment) consists of continuously reinfusing the chyme collected from the proximal small bowel segment via the enterostomy, and into the diverted distal small bowel segment. It implies the use of the Entéromate™ pump.
parenteral nutritionDrug
Parenteral nutrition (the gold standard treatment) consists of electrolyte supplementation, hydration, and nutrition through a central venous catheter.
| Study group | Role | What they receive |
|---|---|---|
| parenteral nutrition | Active comparator | Parenteral nutrition consists of electrolyte supplementation, hydration, and nutrition through a central venous catheter. Receives: Drug: parenteral nutrition |
| chyme reinfusion | Experimental | Chyme reinfusion consists of continuously reinfusing the chyme collected from the proximal small bowel segment via the enterostomy, and into the diverted distal small bowel segment. It implies the use of the Entéromate™ pump. Receives: Device: Entéromate™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of complications occurring in patients with a temporary high-output double enterostomy.
The reestablishment of digestive continuity is possible between Month 3 and Month 8 (it is patient-dependent) The complications, and their severity, will be classed using the Dindo-Clavien classification.
Measured: From the day which the patient no longer requires surgical care after the surgical placement of a temporary double enterostomy (Day 0) and up to 30 days after the reestablishment of digestive continuity (Month 4 (minus) - Month 9 (plus))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study startJan 2017
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal Failure With a Temporary High-output Double EnterostomyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 268 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
- NCT02792543
- Sponsor's protocol ID
- 69HCL16_0098
- Acronym
- FRY
- Status last verified
- Jun 2016
- First submitted
- 2 Jun 2016
- Last updated
- 8 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Chyme Reinfusion Compared to Parenteral Nutrition on the Incidence of Complications in Patients With a Temporary High-output Double Enterostomy: a Multicentre Randomized Controlled Trial - FRY: efFiciency of Reinfusion of chYme - (FRY)
- ClinicalTrials.gov ID
- NCT02792543
- Acronym / sponsor ID
- FRY / 69HCL16_0098
- Keywords
- nutrition, double enterostomy, chyme reinfusion, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 7 Jun 2016 (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.
In the case of intestinal failure with a high-output double enterostomy, the parenteral nutrition (PN) is the gold standard treatment until the surgical reestablishment of digestive continuity. PN has its own morbidity, and in the absence of expertise, the risks of infectious, mechanical, and metabolic complications are increased. Chyme reinfusion (CR) is an enteral nutritional technique which reestablishes the functional continuity of the anatomically present small bowel through an extracorporeal circulation of the chyme. In patients with intestinal failure with a temporary high-output double enterostomy, we hypothesize that CR, compared to PN will reduce post-operative complications after surgical reestablishment of digestive continuity, maintain the intestinal function including absorption, and reduce the complications during the transitional period pending the surgical reestablishment of digestive continuity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| parenteral nutrition | Active comparator | Drug: parenteral nutritionParenteral nutrition consists of electrolyte supplementation, hydration, and nutrition through a central venous catheter. |
| chyme reinfusion | Experimental | Device: Entéromate™Chyme reinfusion consists of continuously reinfusing the chyme collected from the proximal small bowel segment via the enterostomy, and into the diverted distal small bowel segment. It implies the use of the Entéromate™ pump. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged over 18 years
- Temporary high-output double enterostomy (≥1500ml/24 hours)
- Total small bowel length ≥ 120 cm
- Downstream small bowel consisting of at least 25 cm of healthy bowel, accessible by a stoma, and suitable for chyme reinfusion
- Oral feeding resumed for at least 5 days
Key exclusion criteria (8 listed)
- Expected duration of parenteral nutrition or chyme reinfusion less than 2 weeks
- Refusal by the patient to have a mixed texture diet,
- Chemotherapy or radiotherapy before the surgical reestablishment of digestive continuity,
- Not drained intra-abdominal collection,
- Fever, uncontrolled infection, or infection treated for less than 72 hours,
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 |
|---|---|---|
| Entéromate™Also: chyme reinfusionChyme reinfusion (the experimental treatment) consists of continuously reinfusing the chyme collected from the proximal small bowel segment via the enterostomy, and into the diverted distal small bowel segment. It implies the use of the Entéromate™ pump. | Device | chyme reinfusion |
| parenteral nutritionParenteral nutrition (the gold standard treatment) consists of electrolyte supplementation, hydration, and nutrition through a central venous catheter. | Drug | parenteral nutrition |
Primary outcome
The frequency of complications occurring in patients with a temporary high-output double enterostomy.
Time frame: From the day which the patient no longer requires surgical care after the surgical placement of a temporary double enterostomy (Day 0) and up to 30 days after the reestablishment of digestive continuity (Month 4 (minus) - Month 9 (plus))
The reestablishment of digestive continuity is possible between Month 3 and Month 8 (it is patient-dependent) The complications, and their severity, will be classed using the Dindo-Clavien classification.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2016.
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 Entéromate™ and parenteral nutrition in people with Intestinal Failure With a Temporary High-output Double Enterostomy, 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 9 inclusion and 8 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 8 Jun 2016. 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 Cécile CHAMBRIER, MD (+33 4 26 73 26 59, cecile.chambrier@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency of complications occurring in patients with a temporary high-output double enterostomy. (time frame: From the day which the patient no longer requires surgical care after the surgical placement of a temporary double enterostomy (Day 0) and up to 30 days after the reestablishment of digestive continuity (Month 4 (minus) - Month 9 (plus))). 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 8 Jun 2016.