Major Abdominal SurgeryGLYCOCHIPNCT06285526
Glycocalyx Monitoring in Major Abdominal Surgery
An observational study of Major Abdominal Surgery, run by University Hospital, Rouen at 1 site in France.
Trial summary
The study of the microcirculation and glycocalyx could be an essential element in the monitoring of our patients undergoing major abdominal surgery. It would enable us to better target the objectives of anaesthesia and resuscitation, which until now have been based essentially on macro-circulatory parameters. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Major Abdominal Surgery
- What is being tested?
- Cytoreduction surgery with Hyperthermic Intraperitoneal Chemotherapy and Cephalic DuodenoPancreatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 78 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jul 2022to 13 May 2026
- Phase
- Observational
- 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 to 75 years
- All sexes
- Adult, Older adult
Study population: Patient undergoing major abdominal surgery by cytoreduction combined with an intraperitoneal chemotherapy bath (HIPEC) or cephalic duodeno-pancreatectomy (CDP) with epidural analgesia planned in accordance with the department's usual practice
Who may be able to join
- For the HIPEC group :
- Adult patients
- Age < 75 years
- Receiving HIPEC for primary or secondary peritoneal carcinosis
- For the CDP group :
- Adult patient
Show all 10Show fewer
- Age < 75 years
- Receiving CDP for pancreatic neoplasia
- Patient who has read and understood the information letter and does not object to taking part in the study
- Patient affiliated to a social security scheme
Who cannot join
- Secondary distant peritoneal metastases
- Chronic heart failure
- Chronic liver failure at stage C of the Child-Pugh score
- Stage IV or V chronic renal failure
- Inflammation of the sublingual buccal mucosa or injury that may locally influence sublingual microcirculation
- Patient refusal
- Person deprived of liberty by an administrative or judicial decision or person placed under court protection or guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Perioperative Glycocalyx Monitoring in Major Abdominal Surgery
The study of the microcirculation and glycocalyx could be an essential element in the monitoring of our patients undergoing major abdominal surgery. It would enable us to better target the objectives of anaesthesia and resuscitation, which until now have been based essentially on macro-circulatory parameters.
Read the detailed description
This monitoring is possible in real time and real conditions by micro-camera GlycoCheck™ (Microvascular Health Solutions Inc., Salt Lake City, Utah, USA), a non-invasive monitoring allowing the study of sublingual microcirculation and glycocalyx.
- Conditions
- Major Abdominal Surgery
- Being tested
- Cytoreduction surgery with Hyperthermic Intraperitoneal Chemotherapy, Cephalic DuodenoPancreatectomy
- Keywords
- Glycocalyx, Microcirculation, Cephalic DuodenoPancreatectomy, Hyperthermic Intraperitoneal Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytoreduction surgery with Hyperthermic Intraperitoneal ChemotherapyProcedure or surgery
Also called HIPEC
Cytoreduction surgery with Hyperthermic Intraperitoneal Chemotherapy
Cephalic DuodenoPancreatectomyProcedure or surgery
Also called CDP
Cephalic DuodenoPancreatectomy
| Study group | Role | What they receive |
|---|---|---|
| Group HIPEC | Cytoreduction surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) Receives: Procedure: Cytoreduction surgery with Hyperthermic Intraperitoneal Chemotherapy | |
| Group CDP | Cephalic DuodenoPancreatectomy (CDP) Receives: Procedure: Cephalic DuodenoPancreatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycocalyx thickness
Perioperative variation in glycocalyx thickness (µm)
Measured: between the day before the operation (Day -1) and the post-operative period (Day 1)
Secondary outcomes (5)
Glycocalyx thickness and a biological marker of tissue hypoperfusion
To assess, in each population ((HIPEC and CDC), the association between the thickness of the glycocalyx established by analysis of the sublingual microcirculation using GlycoCheck® and a biological marker of tissue hypoperfusion.
Measured: post-operative period (Day 1)
Glycocalyx thickness and a biological marker of tissue hypoxia
Establish the link between glycocalyx thickness and a biological marker of tissue hypoxia.
Measured: post-operative period (Day 1)
Blood cell velocity and macrocirculatory function
Assess the association between velocity of the red blood cells (µm/s) and cardiac index obtained by Most-Care® monitoring on Day 1.
Measured: post-operative period (Day 1)
Perfused capillary density and macrocirculatory function
Assess the association between perfused capillary density (mm/mm2) and cardiac index obtained by Most-Care® monitoring on Day 1.
Measured: post-operative period (Day 1)
Variation of glycocalyx thickness and the daily entry-exit balance (BES) Day 1
To assess the difference between water and fluid intake (perfusion, nutrition, drug dilution solution) and output (diuresis, digestive aspiration, diarrhoea) over 24 hours
Measured: between Day -1 and Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start5 Jul 2022
- Primary completion3 Mar 2025
- Study completion13 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Abdominal SurgeryStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zoé DEMAILLY, Dr, Principal investigator, University Rouen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285526
- Sponsor's protocol ID
- 2023/0046/OB
- Other IDs
- 2023-A00350-45
- Acronym
- GLYCOCHIP
- Status last verified
- Dec 2025
- First submitted
- 2 Jan 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Perioperative Glycocalyx Monitoring in Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT06285526
- Acronym / sponsor ID
- GLYCOCHIP / 2023/0046/OB
- Conditions
- Major Abdominal Surgery
- Keywords
- Glycocalyx, Microcirculation, Cephalic DuodenoPancreatectomy, Hyperthermic Intraperitoneal Chemotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 3 Mar 2025 (actual)
- Study completion
- 13 May 2026 (actual)
- First posted
- 29 Feb 2024 (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.
The study of the microcirculation and glycocalyx could be an essential element in the monitoring of our patients undergoing major abdominal surgery. It would enable us to better target the objectives of anaesthesia and resuscitation, which until now have been based essentially on macro-circulatory parameters.
Detailed description
This monitoring is possible in real time and real conditions by micro-camera GlycoCheck™ (Microvascular Health Solutions Inc., Salt Lake City, Utah, USA), a non-invasive monitoring allowing the study of sublingual microcirculation and glycocalyx.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group HIPEC | – | Procedure: Cytoreduction surgery with Hyperthermic Intraperitoneal ChemotherapyCytoreduction surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) |
| Group CDP | – | Procedure: Cephalic DuodenoPancreatectomyCephalic DuodenoPancreatectomy (CDP) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient undergoing major abdominal surgery by cytoreduction combined with an intraperitoneal chemotherapy bath (HIPEC) or cephalic duodeno-pancreatectomy (CDP) with epidural analgesia planned in accordance with the department's usual practice
Key inclusion criteria (10 listed)
- Adult patients
- Age < 75 years
- Receiving HIPEC for primary or secondary peritoneal carcinosis
- Adult patient
- Age < 75 years
Key exclusion criteria (7 listed)
- Secondary distant peritoneal metastases
- Chronic heart failure
- Chronic liver failure at stage C of the Child-Pugh score
- Stage IV or V chronic renal failure
- Inflammation of the sublingual buccal mucosa or injury that may locally influence sublingual microcirculation
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 |
|---|---|---|
| Cytoreduction surgery with Hyperthermic Intraperitoneal ChemotherapyAlso: HIPECCytoreduction surgery with Hyperthermic Intraperitoneal Chemotherapy | Procedure or surgery | Group HIPEC |
| Cephalic DuodenoPancreatectomyAlso: CDPCephalic DuodenoPancreatectomy | Procedure or surgery | Group CDP |
Primary outcome
Glycocalyx thickness
Time frame: between the day before the operation (Day -1) and the post-operative period (Day 1)
Perioperative variation in glycocalyx thickness (µm)
5 secondary outcomes
Glycocalyx thickness and a biological marker of tissue hypoperfusion
Time frame: post-operative period (Day 1)
Glycocalyx thickness and a biological marker of tissue hypoxia
Time frame: post-operative period (Day 1)
Blood cell velocity and macrocirculatory function
Time frame: post-operative period (Day 1)
Perfused capillary density and macrocirculatory function
Time frame: post-operative period (Day 1)
Variation of glycocalyx thickness and the daily entry-exit balance (BES) Day 1
Time frame: between Day -1 and Day 1
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 22 May 2026.
- Individual participant dataSharing planned: No
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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.
Zoé DEMAILLY, Dr principal investigator
University Rouen Hospital
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 Major Abdominal Surgery, run by University Hospital, Rouen 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 10 inclusion and 7 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 22 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?
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?
Glycocalyx thickness (time frame: between the day before the operation (Day -1) and the post-operative period (Day 1)). 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 22 May 2026.