Glycocalyx Monitoring in Major Abdominal Surgery

NCT06285526 | Unknown

• 2 other identifiers: 2023/0046/OB2023-A00350-45
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major Abdominal Surgery

Keywords

Glycocalyx; Microcirculation; Cephalic DuodenoPancreatectomy; Hyperthermic Intraperitoneal Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Glycocalyx thickness

  Perioperative variation in glycocalyx thickness (µm)

  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

  post-operative period (Day 1)

• Glycocalyx thickness and a biological marker of tissue hypoxia

  post-operative period (Day 1)

• Blood cell velocity and macrocirculatory function

  post-operative period (Day 1)

• Perfused capillary density and macrocirculatory function

  post-operative period (Day 1)

• Variation of glycocalyx thickness and the daily entry-exit balance (BES) Day 1

  between Day -1 and Day 1

Study Arms (2)

Group HIPEC

Cytoreduction surgery with hyperthermic intraperitoneal chemotherapy (HIPEC)

Procedure: Cytoreduction surgery with Hyperthermic Intraperitoneal Chemotherapy

Group CDP

Cephalic DuodenoPancreatectomy (CDP)

Procedure: Cephalic DuodenoPancreatectomy

Interventions

Cytoreduction surgery with Hyperthermic Intraperitoneal Chemotherapy PROCEDURE

Cytoreduction surgery with Hyperthermic Intraperitoneal Chemotherapy

Also known as: HIPEC

Group HIPEC

Cephalic DuodenoPancreatectomy PROCEDURE

Cephalic DuodenoPancreatectomy

Also known as: CDP

Group CDP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• For the HIPEC group :
• Adult patients
• Age \< 75 years
• Receiving HIPEC for primary or secondary peritoneal carcinosis
• For the CDP group :
• Adult patient
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, 76000, France

RECRUITING

MeSH Terms

Interventions

Hyperthermic Intraperitoneal Chemotherapy; Cytidine Diphosphate

Intervention Hierarchy (Ancestors)

Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced; Cytosine Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Zoé DEMAILLY, Dr

  University Rouen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zoé DEMAILLY, Dr

CONTACT

02 32 88 24 40; Zoe.Demailly@chu-rouen.fr

Emmanuel BESNIER, Pr

CONTACT

02 32 88 82 92; Emmanuel.Besnier@chu-rouen.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: February 29, 2024
• Study Start: July 5, 2022
• Primary Completion: January 5, 2025
• Study Completion: January 5, 2025
• Last Updated: July 18, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)