Esophageal CancerFREJENONCT07584577
Evaluation of the Administration of Artificial Nutrition by Feeding Jejunostomy During Neoadjuvant Treatment on Postoperative Morbidity in the Context of Esophageal or Stomach Cancer
An observational study of Esophageal Cancer and Surgery Indication, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Malnutrition is common at the time of diagnosis of esogastric cancers. However, there are no recommendations regarding preoperative nutritional support (type and duration) or on the impact of refeeding on postoperative morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Surgery Indication, Malnourished
- What is being tested?
- Enteral or parenteral nutrition
- How many people
- 670 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2026to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Retrospective case-control study including patients with esophageal cancer treated with neoadjuvant therapy. The control group consists of patients who did not receive enteral or parenteral nutrition during neoadjuvant treatment. The case group consists of patients who received enteral or parenteral nutrition during neoadjuvant treatment.
Who may be able to join
- Patient undergoing surgery for esophageal cancer
- Malnourished patient at the time of management
- Receiving neoadjuvant treatment
Who cannot join
- Patient not malnourished at the time of management
- Patient who did not receive neoadjuvant treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hopîtal du Haut Lévêque
Pessac, 33600
Caroline GRONNIER, + 33 5 57 65 60 05, caroline.gronnier@chu-bordeaux.fr
Caroline GRONNIER, MD, PhD
About this study
Malnutrition is common at the time of diagnosis of esogastric cancers. However, there are no recommendations regarding preoperative nutritional support (type and duration) or on the impact of refeeding on postoperative morbidity and mortality.
Read the detailed description
Malnutrition is frequently associated with esogastric cancers at diagnosis (65-80% of cases). It has been shown that malnutrition in digestive oncology is linked to increased mortality, higher rates of postoperative complications, greater toxicity induced by chemoradiotherapy, and reduced survival. Furthermore, malnutrition present before the start of neoadjuvant treatment is likely to worsen during therapy, due to the occurrence of diarrhea, malabsorption, and dysgeusia during chemotherapy.
However, there are no recommendations regarding the use of nutritional support (type and duration) during the neoadjuvant treatment phase for esogastric cancers. Indeed, the data in the literature are quite heterogeneous regarding the duration of preoperative nutrition, ranging from a few days to several weeks, as well as the type of nutritional support to be used. No study has specifically investigated the evolution of nutritional status during this refeeding phase. As for postoperative complications, the results are mixed, although the trend suggests a reduction in postoperative complications for esophageal surgery. For gastric surgery, only one study examined surgical site infections and found a decrease in incidence when adequate nutrition was provided for more than 14 days before surgery. Nevertheless, postoperative mortality was not affected by improved nutritional status. Most of these studies are small retrospective series. The only prospective studies assessed preoperative nutrition for just 7 days before surgery, with limited sample sizes.
An educational review was published in 2012 highlighting the importance of nutritional support in malnourished patients, recommending nutritional supplementation for all patients: oral supplementation for non-malnourished patients, and jejunostomy feeding for malnourished patients.
In this context, the primary objective of this study is to evaluate the rate of postoperative complications with perioperative enteral nutrition compared to the absence of preoperative enteral nutrition.
- Being tested
- Enteral or parenteral nutrition
- Medical subject headings
- Esophageal Neoplasms, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteral or parenteral nutritionDietary supplement
Patients who did not receive enteral or parenteral nutrition during neoadjuvant treatment.
| Study group | Role | What they receive |
|---|---|---|
| Control group | patients who did not receive enteral or parenteral nutrition during neoadjuvant treatment. | |
| Case group | patients who received enteral or parenteral nutrition during neoadjuvant treatment. Receives: Dietary Supplement: Enteral or parenteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of postoperative complications according to the Clavien classification
Proportion of patients experiencing at least one postoperative complication, classified according to Clavien-Dindo, in malnourished patients with versus without nutritional support.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 670 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- French Eso-Gastric Tumors Working Group
- Responsible party
- Sponsor
- Investigators
- Caroline GRONNIER, MD, PhD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07584577
- Sponsor's protocol ID
- CHUBX 2025/060
- Acronym
- FREJENO
- Status last verified
- May 2026
- First submitted
- 19 Sep 2025
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data access via extraction from the national FREGAT database.
Publications
Mariette C, De Botton ML, Piessen G. Surgery in esophageal and gastric cancer patients: what is the role for nutrition support in your daily practice? Ann Surg Oncol. 2012 Jul;19(7):2128-34. doi: 10.1245/s10434-012-2225-6. Epub 2012 Feb 10.
PubMed 22322948Deftereos I, Kiss N, Isenring E, Carter VM, Yeung JM. A systematic review of the effect of preoperative nutrition support on nutritional status and treatment outcomes in upper gastrointestinal cancer resection. Eur J Surg Oncol. 2020 Aug;46(8):1423-1434. doi: 10.1016/j.ejso.2020.04.008. Epub 2020 Apr 18.
PubMed 32336624Deftereos I, Yeung JM, Arslan J, Carter VM, Isenring E, Kiss N, On Behalf Of The Nourish Point Prevalence Study Group. Preoperative Nutrition Intervention in Patients Undergoing Resection for Upper Gastrointestinal Cancer: Results from the Multi-Centre NOURISH Point Prevalence Study. Nutrients. 2021 Sep 15;13(9):3205. doi: 10.3390/nu13093205.
PubMed 34579082
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Administration of Artificial Nutrition by Feeding Jejunostomy During Neoadjuvant Treatment on Postoperative Morbidity in the Context of Esophageal or Stomach Cancer
- ClinicalTrials.gov ID
- NCT07584577
- Acronym / sponsor ID
- FREJENO / CHUBX 2025/060
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 670 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- French Eso-Gastric Tumors Working Group
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 13 May 2026 (actual)
- 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.
Malnutrition is common at the time of diagnosis of esogastric cancers. However, there are no recommendations regarding preoperative nutritional support (type and duration) or on the impact of refeeding on postoperative morbidity and mortality.
Detailed description
Malnutrition is frequently associated with esogastric cancers at diagnosis (65-80% of cases). It has been shown that malnutrition in digestive oncology is linked to increased mortality, higher rates of postoperative complications, greater toxicity induced by chemoradiotherapy, and reduced survival. Furthermore, malnutrition present before the start of neoadjuvant treatment is likely to worsen during therapy, due to the occurrence of diarrhea, malabsorption, and dysgeusia during chemotherapy.
However, there are no recommendations regarding the use of nutritional support (type and duration) during the neoadjuvant treatment phase for esogastric cancers. Indeed, the data in the literature are quite heterogeneous regarding the duration of preoperative nutrition, ranging from a few days to several weeks, as well as the type of nutritional support to be used. No study has specifically investigated the evolution of nutritional status during this refeeding phase. As for postoperative complications, the results are mixed, although the trend suggests a reduction in postoperative complications for esophageal surgery. For gastric surgery, only one study examined surgical site infections and found a decrease in incidence when adequate nutrition was provided for more than 14 days before surgery. Nevertheless, postoperative mortality was not affected by improved nutritional status. Most of these studies are small retrospective series. The only prospective studies assessed preoperative nutrition for just 7 days before surgery, with limited sample sizes.
An educational review was published in 2012 highlighting the importance of nutritional support in malnourished patients, recommending nutritional supplementation for all patients: oral supplementation for non-malnourished patients, and jejunostomy feeding for malnourished patients.
In this context, the primary objective of this study is to evaluate the rate of postoperative complications with perioperative enteral nutrition compared to the absence of preoperative enteral nutrition.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –patients who did not receive enteral or parenteral nutrition during neoadjuvant treatment. |
| Case group | – | Dietary Supplement: Enteral or parenteral nutritionpatients who received enteral or parenteral nutrition during neoadjuvant treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective case-control study including patients with esophageal cancer treated with neoadjuvant therapy. The control group consists of patients who did not receive enteral or parenteral nutrition during neoadjuvant treatment. The case group consists of patients who received enteral or parenteral nutrition during neoadjuvant treatment.
Key inclusion criteria (3 listed)
- Patient undergoing surgery for esophageal cancer
- Malnourished patient at the time of management
- Receiving neoadjuvant treatment
Key exclusion criteria (2 listed)
- Patient not malnourished at the time of management
- Patient who did not receive neoadjuvant treatment
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 |
|---|---|---|
| Enteral or parenteral nutritionPatients who did not receive enteral or parenteral nutrition during neoadjuvant treatment. | Dietary supplement | Case group |
Primary outcome
Rate of postoperative complications according to the Clavien classification
Time frame: Day 30
Proportion of patients experiencing at least one postoperative complication, classified according to Clavien-Dindo, in malnourished patients with versus without nutritional support.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Background: PubMed 22322948Mariette C, De Botton ML, Piessen G. Surgery in esophageal and gastric cancer patients: what is the role for nutrition support in your daily practice? Ann Surg Oncol. 2012 Jul;19(7):2128-34. doi: 10.1245/s10434-012-2225-6. Epub 2012 Feb 10.
- Background: PubMed 32336624Deftereos I, Kiss N, Isenring E, Carter VM, Yeung JM. A systematic review of the effect of preoperative nutrition support on nutritional status and treatment outcomes in upper gastrointestinal cancer resection. Eur J Surg Oncol. 2020 Aug;46(8):1423-1434. doi: 10.1016/j.ejso.2020.04.008. Epub 2020 Apr 18.
- Background: PubMed 34579082Deftereos I, Yeung JM, Arslan J, Carter VM, Isenring E, Kiss N, On Behalf Of The Nourish Point Prevalence Study Group. Preoperative Nutrition Intervention in Patients Undergoing Resection for Upper Gastrointestinal Cancer: Results from the Multi-Centre NOURISH Point Prevalence Study. Nutrients. 2021 Sep 15;13(9):3205. doi: 10.3390/nu13093205.
- Individual participant dataSharing planned: Yes. Data access via extraction from the national FREGAT database.
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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.
Caroline GRONNIER, MD, PhD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer and Surgery Indication, run by University Hospital, Bordeaux 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 2 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: looking for participants now, as of the sponsor's last update on 13 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline GRONNIER, PhD, MD (+335-57-62-24-77, caroline.gronnier@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of postoperative complications according to the Clavien classification (time frame: Day 30). 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 NCT07584577, which also lists 3 linked publications.
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 13 May 2026.