Gastric Volumetry by Gastric Tomodensitometry With Gas (VOLUSCAN)

August 27, 2025 updated by: Hospices Civils de Lyon

Evolution of Gastric Volume Measured by Gastric Tomodensitometry With Gas After Gastric Bypass Surgery or Sleeve Gastrectomy. Research for a Correlation With Weight Evolution : Pilot Study.

The Gastric bypass (GBP) is actually one of the most performed bariatric procedures worldwide. Short term results report 67% of mean Excess Weight Loss (EWL) at 2 years, and 58% EWL at 5 years. Sleeve gastrectomy (SG) which is a restrictive procedure has gained in popularity because of its technical simplicity and its efficiency (60% EWL at 1 year and 48% over 4 years). However, failures are observed because of insufficient weight loss or early weight regain. Several hypotheses have been proposed to explain these failures, such as the size of the gastric pouch that could be correlated to weight evolution.

Purpose of the study Taking the hypothesis that a progressive dilatation of the gastric pouch is one of the main factors of weight loss failure after GBP or SG due to the loss of its restrictive function, the aim of our study is to measure these gastric volumes using gastric tomodensitometry with gas, a new reliable,precise and 3 dimension radiological technique. The investigators will try to identify a positive correlation between gastric dilatation and weight regain.

Methods This is a 2 year interventional, prospective, monocentric study with longitudinal follow-up. Forty-five obese patients (BMI>40kg/m²) eligible for primary GBP (n=25) or SG (n=20) will be included. Gastric volumes will be measured by gastric tomodensitometry with gas at 3 and 12 month after surgery. In the GBP group, the investigators will measure the gastric pouch volume, the candy cane Roux limb volume, the neostomach volume (= gastric pouch+candy cane Roux limb) and the gastro-jejunal anastomosis diameter. In the SG group, the investigators will measure the volume of the gastric tube, of the non resectedantrum, of the whole residual stomach and the gastric tube diameter at the middle of the small curvature. Volume variations between 3 and 12 months will be compared to the EWL and to clinical and metabolic data (HbA1c, Insulinemia, HOMA index, liver steatosis). A 30% dilatation of the neostomach at 12 months will be considered as significant. Reinhold's criteria will be used to define surgical failure: EWL<50% at 12 months. Weight regain will be considered as significant if the weight reached at 12 months is higher than the minimum weight obtained. Gastric volume variation, EWL and BMI evolution between the 3rd and the 12th month will be analysed in the whole population and in each group (GBP and SG) with a Wilcoxon test.

Expected benefits If the investigators valid the hypothesis that the dilatation of the neostomach is an essential factor in weight regain after GBP and SG, the benefit for the patient will be dual: 1/ validate the prognostic value of gastric volumetry by gastric tomodensitometry with gas in order to explain weight regain, and in order to use it as a standard. 2/ the identification of specific risk factors related to the surgical procedure could result in surgical technique improvements as well as a better adaptation of revisional procedures, in order to improve treatment of recurrent obesity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69003
        • Hospices Civils de Lyon- hôpital Edouard Herriot- service de Chirurgie Digestive

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients of both genders, with morbid obesity (BMI > or = 40kg / m ²)
  • Age included between 18 and 60 years
  • Patient who requires a gastric bypass or a Sleeve gastrectomy as a 1st bariatric procedure. Indication validated in pluridisciplinary concertation meeting for bariatric surgery
  • No previous history of bariatric surgery
  • Free and informed consent signed
  • Being affiliated to a French social security system or similar.

Exclusion Criteria:

  • Bariatric surgery with metabolic aim (BMI < 40kg / m ²)
  • Patients with a history of bariatric surgery, after failure of one or several previous procedures
  • Contraindication to radiation exposition: current or planned pregnancy during the study
  • prostate adenoma : contraindication to antispasmodic
  • Known allergy to effervescent salts or butylscopolamine (Scoburen)
  • Glaucoma
  • Inability to express a consent
  • Unaffiliated patients to a French national insurance
  • Patients with Pacemaker
  • Patients already enrolled in a study with a conflict of interest with this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with morbid obesity
Patients with morbid obesity and who requires a gastric bypass or a Sleeve gastrectomy as a 1st bariatric procedure.
Device: gastric tomodensitometry with gas at 3 months and 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the neostomach volume measured by gastrictomodensitometry with gas
Time Frame: 3 and 12 month
3 and 12 month
the subjects' weight at the 3rd and the 12th month after GBP or SG
Time Frame: 3 and 12 months
3 and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
the neostomach volume at 12 months and total weightloss
Time Frame: 12 month
12 month
determination of the positive predictive value of the neostomach volume at 3 months, on weight evolution at 12 months after GBP or SG
Time Frame: 3 and 12 month
3 and 12 month
the volume of the neostomach at 3 and 12 months between the subjects who gain weight and thosewho do not
Time Frame: 3 and 12 month
3 and 12 month
standard values for gastricvolumetry by gastrictomodensitometry with gas, at 3 and 12 months after GBP or SG
Time Frame: 3 and 12 month
3 and 12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: MAUD ROBERT, MD, Hospices Civils de Lyon- Hôpital Edouard Herriot

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

October 10, 2013

First Submitted That Met QC Criteria

October 11, 2013

First Posted (Estimated)

October 16, 2013

Study Record Updates

Last Update Posted (Estimated)

September 4, 2025

Last Update Submitted That Met QC Criteria

August 27, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012.721
  • 2012-A00591-42 (Other Identifier: ID-RCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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