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WithdrawnNCT04668651PEGASEDUpdated Dec 3, 2025

Preoperative Evaluation of Gastric Contents by Antral Ultrasound in Diabetic Patients

An observational study in Diabetes, sponsored by Centre Hospitalier Universitaire de Nice. Withdrawn at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-03.

Sponsored by Centre Hospitalier Universitaire de Nice · Observational

Why this study was withdrawn
The principal investigator has left Nice University Hospital and no other doctor has taken over for the study.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study summary

Gastric aspiration represents the third cause of perioperative death in France. In scheduled surgery, it can be prevented by preoperative fasting. The French and American guidelines recommend a fasting of 2 hours for clear liquids and 6 hours for solid food. However, these durations could be too short in case of delayed gastric emptying due to medications of diabetes for example. This latter condition has an increasing incidence. Numerous complications are related to chronic hyperglycemia including delayed gastric emptying also known as gastroparesis. Around one third of diabetic patients presents this complication.

Gastric ultrasound represents a non-invasive method to explore the stomach. It allows the qualitative and quantitative evaluations of gastric content.

As diabetic patients present a risk of non-empty stomach despite fasting,investigators decided to conduct a prospective observational study compare the appearance of the stomach assessed by ultrasonography between diabetic and non-diabetic patients before scheduled surgery

Read the detailed description

Gastric aspiration represents the third cause of perioperative death in France. The physiopathology of this complication is multifactorial, implying among other things the lack of respect for the rules of preoperative fasting, especially during emergency operations. Indeed, the presence of food content in the stomach, combined with the decrease in the pressure of the lower sphincter of the esophagus and the protection of the upper airways during the induction of general anesthesia, is accompanied by a significant increase in the risk of regurgitation and inhalation of gastric contents.

There are more than 3 million diabetic patients in France, with an increase in prevalence of more than 5% per year. The main digestive disorder linked to autonomic neuropathy in the diabetic subject is represented by gastroparesis, characterized by a delay in gastric emptying without mechanical impediment, associated with signs of abnormal gastric motility. Gastroparesis results from an impairment of the neurovegetative regulation of the stomach related to exposure to prolonged hyperglycemia. It is estimated that approximately 1/3 of diabetics are affected.

Ultrasound measurement of the antral section area was originally described for the evaluation and study of gastric emptying in obstetrics and medicine. Several studies have shown the interest of this measurement for the evaluation of gastric content and volume in the preoperative period. The antral ultrasound makes it possible to discriminate a "full" stomach from an "empty" stomach with excellent performance. Thus, investigators have at our disposal a simple and non-invasive tool to evaluate in real time the state of gastric vacuity in patients in the operating room.

In practice, ultrasound measurement of the antral section area is performed using an ultrasound scanner equipped with a 2-5 MHz frequency probe. The diameters (longitudinal D1 and anteroposterior D2) of the antrum are measured in the sagittal plane passing through the abdominal aorta and the left lobe of the liver. The value of the antral cross-sectional area is given by the formula: antral area = π x D1 x D2 / 4. This ultrasound measurement of the antral cross-sectional area is commonly performed in the operating room and is recommended in some anesthesia reference books. Several mathematical models have been constructed, in adults and children, to calculate the volume of gastric contents based on this measurement of anal area, with satisfactory accuracy (R² = 0.72 to 0.86). Gastric ultrasound is easily performed at the patient's bedside, before general or local anesthesia, and its use has recently been described to study gastric emptying.

Investigators would like to evaluate the gastric content in diabetics in the perioperative period.

02

Conditions studied

  • Diabetes

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03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

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Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Any treated diabetic and non-diabetic patient requiring elective vascular surgery

Inclusion criteria

  • Age > 18 years old
  • Any treated diabetic and non-diabetic patient requiring elective vascular surgery who has agreed to participate in the study (consent form obtained).
  • Affiliation or beneficiary of social security.

Exclusion criteria

Exclusion Criteria:

  • Pregnant woman
  • Persons of full age protected by law
  • Patient Refusal
  • Patient deprived of liberty
  • History of gastric surgery
  • Any situation requiring urgent treatment that is not compatible with the performance of a gastric ultrasound scan.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • diabetic

    diabetic patients

    Other: antral ultrasound

  • non diabetic

    non-diabetic patients

    Other: antral ultrasound

Interventions

  • Otherantral ultrasound

    Preoperative evaluation of gastric contents by antral ultrasound

06

What researchers measure

Primary outcomes

  1. Antral content

    Evaluation of antral content according to the Perlas classification (0, 1 or 2) and antral surface area between diabetic and non-diabetic patients.

    Time frame: Preoperative

Secondary outcomes

  1. Antral area

    Evaluation of antral surface area between diabetic and non-diabetic patients

    Time frame: Pre-operative, on arrival in the operating room

  2. Perlas grades

    Evaluation of Perlas grades between diabetic and non-diabetic patients

    Time frame: Pre-operative, on arrival in the operating room

  3. Characteristics of diabetes

    Correlate the antral surface area and characteristics of diabetes (type, duration, glycosylated hemoglobin results)

    Time frame: Pre-operative, on arrival in the operating room

  4. Clinical signs of diabetic gastroparesis

    Evaluation of antral surface area and clinical signs of diabetic gastroparesis

    Time frame: Pre-Anesthesia Consultation

  5. Perioperative respiratory complications

    Correlate the antral surface and perioperative respiratory complications: inhalation, pneumopathy and respiratory distress

    Time frame: Peri-operative

07

Study locations

1 site
  • CHU de Nice
    Nice, PACA 06000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04668651
Lead sponsor
Centre Hospitalier Universitaire de Nice
Responsible party
Sponsor
First posted
Dec 16, 2020
Start date
Jan 12, 2021
Primary completion
Apr 5, 2021
Completion
Apr 5, 2021
Last update
Dec 3, 2025

Study contacts

Jean-Christophe ORBAN
principal investigator · Centre Hospitalier Universitaire de Nice

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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