OesophagectomyOESOCALNCT06921668
Perioperative Dynamics of Energy Expenditure in Oesophagectomy Patients
An observational study of Oesophagectomy, run by University Hospital, Rouen at 4 sites in France.
Trial summary
Carcinological oesophageal resection surgery is one of the so-called major digestive surgeries, i.e. involving a high perioperative risk (morbidity and mortality) in patients who are malnourished or at high risk of malnutrition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oesophagectomy
- How many people
- 120 participants
- Where
- 4 sitesFrance
- Study dates
- 1 Sep 2024to 2 Jan 2028
- 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: Consecutive adult patient admitted for digestive surgery for Lewis Santy oesophagectomy
Who may be able to join
- Any adult patient admitted for scheduled digestive surgery for Lewis Santy oesophagectomy whose care pathway includes a stay in an intensive care unit or continuing care unit.
- Member or beneficiary of a social protection scheme
- Patient who has read and understood the information letter and does not object to taking part in the study.
Who cannot join
- Contraindication to indirect calorimetry (oxygen therapy, etc.)
- Refusal to take part in the study
- No social security affiliation
- Patient is a minor
- Patient under legal protection (guardianship)
- Pregnant women
- Oesophagectomy with cervical approach (3-way oesophagectomy)
- Participation in an interventional research protocol likely to have an effect on perioperative nutritional status or surgical technique
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Not yet recruiting
Service d'Anesthésie-Réanimation
Amiens, 80054
Léonie LV VILLERET, Doctor, 3 22 08 78 78 ext. +33, villeret.leonie@chu-amiens.fr
- Not yet recruiting
Department of Anaesthesia and Intensive Care
Brest, 29200
Thomas TG GARGADENNEC, Doctor, 2 30 33 78 94 ext. +33, thomas.gargadennec@chu-brest.fr
- Recruiting
Surgical Intensive Care Department
Rouen, 76031
Emilie EO OCCHIALI, Doctor, 2 32 88 17 29 ext. +33, emilie.occhiali@chu-rouen.fr
Anaïs AC CREY, Doctor, 2 32 88 17 29 ext. +33, anais.crey@chu-rouen.fr
- Not yet recruiting
Department of Anaesthesia, Intensive Care and Perioperative Medicine
Vandœuvre-lès-Nancy, 54511
Julien JB BIRCKENER, Doctor, 3 83 15 52 39 ext. +33, j.birckener@chru-nancy.fr
About this study
Official title: Perioperative Dynamics of Energy Expenditure in Lewis-Santy Oesophagectomy Patients
Carcinological oesophageal resection surgery is one of the so-called major digestive surgeries, i.e. involving a high perioperative risk (morbidity and mortality) in patients who are malnourished or at high risk of malnutrition.
Nutritional therapy for these patients is an important part of overall perioperative management. Lewis-Santy oesophageal surgery requires a thoracic approach (thoracotomy or thoracoscopy) and an abdominal approach (laparotomy or laparoscopy).
Read more
Resumption of oral feeding is contraindicated in the immediate postoperative period. The use of a feeding jejunostomy is not systematic. The methods used to manage artificial nutritional support vary between centres, but the foreseeable duration of fasting and/or intake of less than 50% of nutritional requirements is always greater than 5 days.
At present, total energy requirements are calculated using formulae that take into account the patient's inflammatory state (stable, unstable or stabilised patient), theoretical ideal weight and previous nutritional status, in order to come as close as possible to actual energy expenditure, and are the subject of perioperative nutrition protocols specific to each centre. Indirect calorimetry makes it possible to reliably measure energy expenditure during the perioperative period.
The OESOCAL study continues this line of reasoning. It assumes that energy expenditure may vary according to the surgical approach, and that indirect calorimetry can be used to optimise nutritional support in order to avoid over- or under-nutrition, which may be responsible for an increase in infectious complications.
Read the detailed description
The results of this study should enable current nutrition protocols to evolve and nutritional support to be incorporated into a more global project of individualised perioperative medicine.
- Conditions
- Oesophagectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining perioperative dynamics of energy expenditure
Describe the perioperative dynamics of energy expenditure in patients undergoing Lewis-Santy carcinological oesophagectomy as a function of surgical technique by indirect calorimetry (assessing resting energy expenditure ).
Measured: Perioperative resting energy expenditure: preoperatively on Day-21/Day-15 or Day-1 of the operation and postoperatively on Day2-Day4 and Day6-Day8
Secondary outcomes (5)
Total nutritional intake (vitamin intake)
Assessing patients' total nutritional intake in the perioperative period
Measured: pre-operatively on Day-21/Day-15 or Day-1 of the operation and post-operatively on Day2-Day4
Total nutritional intake (parenteral/enteral nutrition)
Post-operative nutritional support: parenteral/enteral nutrition intake
Measured: pre-operatively on Day-21/Day-15 or Day-1 of the operation and post-operatively on Day2-Day4
Total nutritional intake (Trace elements)
Post-operative nutritional support: trace elements intake
Measured: pre-operatively on Day-21/Day-15 or Day-1 of the operation and post-operatively on Day2-Day4
Comparison of calorie targets set with data measured by indirect calorimetry
Comparison of calorie targets set by the postoperative artificial nutrition protocol with data measured by indirect calorimetry
Measured: Perioperative resting energy expenditure: preoperatively on Day-21/Day-15 or Day-1 of the operation and postoperatively on Day2-Day4 and Day6-Day8
Post-operative complications
Postoperative morbidity and mortality, surgical complications evaluation
Measured: at 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start1 Sep 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion2 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OesophagectomyStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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 only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie EO OCCHIALI, Doctor, Study chair, Surgical Intensive Care Unit, UH of Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921668
- Sponsor's protocol ID
- 2023/0271/OB
- Other IDs
- IDRCB : 2023-A02724-41
- Acronym
- OESOCAL
- Status last verified
- May 2024
- First submitted
- 19 Mar 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data provided will be the property of the sponsor and will be used solely for its own research activities.
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Dynamics of Energy Expenditure in Lewis-Santy Oesophagectomy Patients
- ClinicalTrials.gov ID
- NCT06921668
- Acronym / sponsor ID
- OESOCAL / 2023/0271/OB
- Conditions
- Oesophagectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 2 Jan 2028 (estimated)
- First posted
- 10 Apr 2025 (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.
Carcinological oesophageal resection surgery is one of the so-called major digestive surgeries, i.e. involving a high perioperative risk (morbidity and mortality) in patients who are malnourished or at high risk of malnutrition.
Nutritional therapy for these patients is an important part of overall perioperative management. Lewis-Santy oesophageal surgery requires a thoracic approach (thoracotomy or thoracoscopy) and an abdominal approach (laparotomy or laparoscopy).
Resumption of oral feeding is contraindicated in the immediate postoperative period. The use of a feeding jejunostomy is not systematic. The methods used to manage artificial nutritional support vary between centres, but the foreseeable duration of fasting and/or intake of less than 50% of nutritional requirements is always greater than 5 days.
At present, total energy requirements are calculated using formulae that take into account the patient's inflammatory state (stable, unstable or stabilised patient), theoretical ideal weight and previous nutritional status, in order to come as close as possible to actual energy expenditure, and are the subject of perioperative nutrition protocols specific to each centre. Indirect calorimetry makes it possible to reliably measure energy expenditure during the perioperative period.
The OESOCAL study continues this line of reasoning. It assumes that energy expenditure may vary according to the surgical approach, and that indirect calorimetry can be used to optimise nutritional support in order to avoid over- or under-nutrition, which may be responsible for an increase in infectious complications.
Detailed description
The results of this study should enable current nutrition protocols to evolve and nutritional support to be incorporated into a more global project of individualised perioperative medicine.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult patient admitted for digestive surgery for Lewis Santy oesophagectomy
Key inclusion criteria (3 listed)
- Any adult patient admitted for scheduled digestive surgery for Lewis Santy oesophagectomy whose care pathway includes a stay in an intensive care unit or continuing care unit.
- Member or beneficiary of a social protection scheme
- Patient who has read and understood the information letter and does not object to taking part in the study.
Key exclusion criteria (8 listed)
- Contraindication to indirect calorimetry (oxygen therapy, etc.)
- Refusal to take part in the study
- No social security affiliation
- Patient is a minor
- Patient under legal protection (guardianship)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determining perioperative dynamics of energy expenditure
Time frame: Perioperative resting energy expenditure: preoperatively on Day-21/Day-15 or Day-1 of the operation and postoperatively on Day2-Day4 and Day6-Day8
Describe the perioperative dynamics of energy expenditure in patients undergoing Lewis-Santy carcinological oesophagectomy as a function of surgical technique by indirect calorimetry (assessing resting energy expenditure ).
5 secondary outcomes
Total nutritional intake (vitamin intake)
Time frame: pre-operatively on Day-21/Day-15 or Day-1 of the operation and post-operatively on Day2-Day4
Total nutritional intake (parenteral/enteral nutrition)
Time frame: pre-operatively on Day-21/Day-15 or Day-1 of the operation and post-operatively on Day2-Day4
Total nutritional intake (Trace elements)
Time frame: pre-operatively on Day-21/Day-15 or Day-1 of the operation and post-operatively on Day2-Day4
Comparison of calorie targets set with data measured by indirect calorimetry
Time frame: Perioperative resting energy expenditure: preoperatively on Day-21/Day-15 or Day-1 of the operation and postoperatively on Day2-Day4 and Day6-Day8
Post-operative complications
Time frame: at 6 and 12 months
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 10 Apr 2025.
- Individual participant dataSharing planned: No. The data provided will be the property of the sponsor and will be used solely for its own research activities.
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Esophageal Cancer
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OBSiDiAN in a Stapled Circular Esophagogastric Anastomosis After Ivor Lewis Esophagectomy
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Endoluminal Vacuum Therapy to Prevent Anastomotic Leakage After Esophagectomy Due to Esophageal Cancer
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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.
Emilie EO OCCHIALI, Doctor study chair
Surgical Intensive Care Unit, UH of Rouen
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oesophagectomy, run by University Hospital, Rouen at 4 sites 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 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: looking for participants now, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 David DM MALLET, Director (2 32 88 82 65 ext. +33, Secretariat.DRC@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determining perioperative dynamics of energy expenditure (time frame: Perioperative resting energy expenditure: preoperatively on Day-21/Day-15 or Day-1 of the operation and postoperatively on Day2-Day4 and Day6-Day8). 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 10 Apr 2025.